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Traumatic brain injury (TBI) is a leading cause of acquired disability in children, who are at risk of significant impairment in executive function (EF). Virtual reality technology provides a novel strategy to offer rich and immersive training content that is both appealing to children and of potential value in improving their daily functioning. The present study aimed to evaluate the feasibility and safety of implementing an innovative VR-based interactive cognitive training (VICT) system for EF rehabilitation designed to meet the developmental and clinical needs of children with TBI.A parallel-group random-block randomized controlled trial was conducted among 26 children 7-17 years with TBI, who completed baseline, postintervention, and 2-month follow-up visits. Feasibility was assessed for recruiting children, measuring outcomes, and implementing the intervention. VR satisfaction was assessed via 5-point Likert scales. Safety outcomes included simulator sickness (0-4) and physical exertion (6-20). Preliminary efficacy was assessed by NIH Toolbox Cognitive Battery tasks.Findings supported the feasibility of recruitment, outcome assessment, and delivery of the intervention. The intervention group reported adequate VR satisfaction in terms of pleasure (The present study found high feasibility, safety, and preliminary efficacy of the VICT system. Further research is required to fully examine the intervention's efficacy as a possible rehabilitation tool for children with TBI. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Objective The aim of the study was to validate a revised version of the Second Victim Experience and Support Tool (SVEST-R). The SVEST survey instrument was developed to measure the emotional and professional impact of medical errors and adverse patient events on healthcare providers and can help healthcare organizations evaluate the effectiveness of support resources. Methods An SVEST-R was completed by 316 healthcare providers from seven neonatal intensive care units affiliated with a large, pediatric hospital. The original 29-item measure was expanded to 43 items to assess eight psychosocial domains (psychological distress, physical distress, colleague support, supervisor support, institutional support, nonwork-related support, professional self-efficacy, resilience) and two employment-related domains (turnover intentions, absenteeism) associated with the second victim experience. Seven additional items assessed desired forms of support (e.g., time away from the unit). A confirmatory factor analysis evaluated the factor structure of the modified measure. Results The initial confirmatory factor analysis did not reveal an acceptable factor structure; thus, eight items were removed because of inadequate factor loadings or for conceptual reasons. This resulted in an acceptable model for the final 35-item measure. The final version included nine factors (i.e., psychological distress, physical distress, colleague support, supervisor support, institutional support, professional self-efficacy, resilience, turnover intentions, and absenteeism), with Cronbach α ranging from 0.66 to 0.86. Conclusions The SVEST-R is a valid measure for assessing the impact of errors or adverse events on healthcare providers. Importantly, the SVEST-R now includes positive outcomes (i.e., resilience) that may result from the second victim experience.

Objective The current study aimed to (a) describe moderate-to-vigorous physical activity (MVPA), sedentary behavior (SB), and cardiorespiratory fitness (VO2Peak) via objective assessment among adolescents with congenital heart disease (CHD), (b) examine gender differences on MVPA, SB, VO2Peak, and the Theory of Planned Behavior elements, and (c) identify whether gender moderates the relationships between the Theory of Planned Behavior elements and MVPA, SB, and VO2Peak. Methods Adolescent CHD survivors (N = 86; ages 15–18 years) wore an accelerometer to assess MVPA and SB, underwent an exercise stress test to assess VO2Peak, and completed a survey of the Theory of Planned Behavior elements as measured by perceived benefits (attitudes), family/friend support and perceived norms (social norms), and self-efficacy and barriers (perceived behavioral control) to engaging in physical activity. Results On average, CHD survivors engaged in 22.3 min (SD = 15.3) of MVPA/day and 9 hr of SB/day (M = 565.8, SD = 102.5 min). Females engaged in less MVPA but not more SB had a lower mean VO2Peak, reported lower self-efficacy, and perceived greater barriers than males. In a regression model, barriers explained unique variance in MVPA and VO2Peak, but the relationship between barriers and MVPA/VO2Peak did not vary by gender. Self-efficacy did not explain unique variance in MVPA and VO2Peak when included in a model with gender and barriers. Conclusions Family/friend support for physical activity engagement may be an important consideration when developing physical activity interventions for adolescent CHD survivors. The role of gender differences in self-efficacy and perceived barriers on physical activity engagement warrants further investigation.

Background Neonatal care of preterm infants may include dietary approaches such as high calorie formulas to promote physical growth. However, continuing growth-promoting strategies beyond the point of necessity, coupled with poverty and food insecurity which are more common among families of children born preterm, may increase the risk of obesity. Because children born preterm tend to have more pressing health conditions that require ongoing care, obesity may go undiagnosed by providers. Methods This retrospective cohort study included 38,849 children (31,548 term, 7301 preterm) born from 2010 to 2015, who received clinical care at a large pediatric medical center (Ohio, USA). Electronic medical record data, linked to Ohio birth certificates, were used to identify children with measured obesity (≥2 weight-for-length values ≥95th percentile before 24 months of age or BMI values ≥95th percentile at or after 24 months of age). Children were considered to have diagnosed obesity if their medical record had an obesity-related phrase or billing code recorded. Modified Poisson regression was used to compare risk of obesity undiagnosis among obese children born preterm versus at term. Results In total, 13,697 children had measured obesity, 10,273 (75%) of which were undiagnosed. Children born preterm with measured obesity were 8% more likely to be undiagnosed compared to children born at term (adjusted relative risk = 1.08 95% CI 1.05, 1.11). The risk was slightly higher for preterm children born to white women or born to women with higher educational attainment. For both groups, Primary Care and subspecialist clinics were the most common settings for undiagnosed obesity (74.9% and 16.8% of undiagnosed cases, respectively). Conclusions and relevance Preterm birth was associated with increased risk of undiagnosed obesity in early childhood. This highlights the need to enhance obesity screening in the preterm population and to further explore reasons for this disparity.

Contamination, when members of a comparison or control condition are exposed to the event or intervention under scientific investigation, is a methodological phenomenon that downwardly biases the magnitude of effect size estimates. This study tested a novel approach for controlling contamination in observational child maltreatment research. Data from The Longitudinal Studies of Child Abuse and Neglect (LONGSCAN; N = 1354) were obtained to estimate the risk of confirmed child maltreatment on trajectories of internalizing and externalizing behaviors before and after controlling contamination. Baseline models, where contamination was uncontrolled, demonstrated a risk for greater internalizing (b = .29, p < .001, d = .40) and externalizing (b = .14, p = .040, d = .19) behavior trajectories. Final models, where contamination was controlled by separating the comparison condition into subgroups that did or did not self-report maltreatment, also demonstrated risks for greater internalizing (b = .37, p < .001, d = .51) and externalizing (b = .22, p = .028, d = .29) behavior trajectories. However, effect size estimates in final models were 27.5%–52.6% larger compared to baseline models. Controlling contamination in child maltreatment research can strengthen effect size estimates for child behavior problems, aiding future child maltreatment research design and analysis.

Evidence on the role of early growth trajectories and later obesity risk is primarily based on privately insured or universally insured samples.We aimed to characterize and determine factors associated with early growth trajectories and estimate associations with overweight/obesity risk in a Medicaid-insured and uninsured cohort.Infants seen at a large pediatric academic centre in 2010-2016 were included. Weight and length/height measurements were converted to age and sex-specific BMI z-scores (BMIz) based on the World Health Organization (WHO) Growth Standards. Group-based trajectories were modelled using BMIz created groups. Logistic and log-binomial regression models estimated associations between membership in trajectories and maternal/child factors and overweight or obesity at 36, 48, and 60 months, separately. Analyses were performed between 2019 and 2021.The best-fitting model identified five BMIz trajectories among 30 189 children and 310 113 clinical encounters; two trajectories showed rapid rise in BMIz. Lower maternal education, pre-pregnancy maternal overweight/obese status, and maternal smoking were positively associated with both rapid-rising BMIz trajectories. Children in either of the two rapid-rising trajectories were 3.00 (95% CI: 2.85, 3.25), 2.97 (95% CI: 2.77, 3.18) and 2.76 (95% CI: 2.53, 3.01) times more likely to have overweight or obesity at 36, 48, and 60 months, respectively compared to children in the stable trajectory groups.Among Medicaid insured and uninsured children, several maternal and child characteristics were associated with early rapid-rise in BMIz. Clinical monitoring of early rapidly rising BMI may be important to address modifiable risk factors for obesity in families from low-income households.

Youth with craniofacial conditions often have appearance and speech differences and are vulnerable to social stigmatization and body image disturbances. Given sociocultural pressures for female attractiveness, adolescent girls with craniofacial conditions may be especially vulnerable to body dissatisfaction and appearance-related social stigmatization, though such sex differences have been infrequently studied in this population. This study aimed to: (1) examine sex differences in body image disturbance, satisfaction with speech and facial appearance, and perceived stigmatization among adolescents with craniofacial conditions; and (2) evaluate whether stigmatization perceptions are predictive of body image disturbance and satisfaction with facial appearance and speech. Using a cross-sectional design, 110 adolescents from two craniofacial centers completed measures of body image disturbance, satisfaction with speech and facial appearance, and perceived stigmatization. Females reported significantly greater levels of body image disturbance and lower satisfaction with facial appearance compared to males. There were no significant sex differences for satisfaction with speech or perceived stigmatization. Perceived stigmatization was a significant predictor of body image disturbance, and satisfaction with facial appearance and speech while controlling for sex, body mass index, and age. Interventions to prevent and/or address body image and stigmatization concerns are clinically indicated for both sexes.

BACKGROUND: Infants who are admitted to a neonatal intensive care unit (NICU) may experience significant symptom burden. Parents are often distressed by these symptoms, which can affect their long-term coping and distress. There is limited research examining nurse perceptions of infant well-being (symptoms, suffering, and quality of life (QOL) and associations with nurse distress. OBJECTIVE: The objective of this descriptive study was to explore associations between nurse perceptions of infant well-being and self-reported distress. METHODS: Nurses caring for infants with potentially life-threatening/life-limiting conditions were recruited from a Level IV NICU in the Midwestern United States as a part of a study on infant symptom burden. Nurses reported their perceptions of infant well-being and their own distress on a five-point Likert scale. Surveys were administered at the bedside weekly for up to twelve weeks depending on length of stay. Infant suffering and QOL were examined in relation to nurse distress. A cross-classified multilevel model was used to account for dependence within nurse and within patient. RESULTS: A total of 593 surveys were collected from nurses. Using a cross-classified multilevel model with variables entered simultaneously, nurse perception of greater infant suffering and lower infant QOL were significantly associated with greater nurse distress. DISCUSSION: Preliminary evidence shows that greater perceived infant suffering and lower perceived infant QOL may be associated with greater levels of self-reported distress in NICU nurses. Further work is needed to better understand factors related to symptom management in the NICU and the potential role of caregiver distress and compassion fatigue in NICU nurses.

BACKGROUND Dietary DHA intake among US toddlers is low. Healthy physical growth is an important objective for the clinical care of children born preterm. OBJECTIVES The aim of the trial was to examine the effects of supplementing toddlers born preterm with DHA and arachidonic acid (AA) for 180 d on growth and adiposity. METHODS Omega Tots, a randomized placebo-controlled trial, was conducted between April 2012 and March 2017. Children born at

This double-blind, randomized controlled trial, tested fatty acid (FA) supplementation in children (ages 2- 6 years) recently diagnosed with Autism Spectrum Disorder (ASD). Participants received daily oral FA supplement containing omega-3 and omega-6 FA, or a placebo for 90 days based on participant weight. Erythrocyte FAs and the cytokines, IL-1β, IL-2, IFNγ, were measured in plasma obtained from serial blood collections. Treatment increased omega-3 and omega-6 FA levels (1.40 mol% for EPA and 1.62 mol% for DHA) and reduced IL-2 levels compared to placebo (- 0.17 pg/mL, 95% CI - 0.31, - 0.02, d = - 0.62). Omega 3-6 treatment was tolerable and adherence was greater than 70%. Future research will assess the effects of Omega 3-6 treatment on ASD symptoms. Registered on 06/08/2018 with ClinicalTrials.gov: NCT03550209.

Selective eating is a common childhood feeding problem associated with family stress and micronutrient deficiencies. While there are empirically-supported behavioral strategies for addressing selective eating, there are significant systems-level barriers to implementing them. The aim of this study was to develop and test a self-administered intervention for parents of children with selective eating. Participants were 156 parents of children with selective eating ages 18 months-6 years who were randomly assigned to either the handout + video condition (8-module video intervention and detailed handout) or handout condition (detailed handout only). Outcome measures were administered pre-intervention and 4 weeks post-intervention. Only 23 % of participants in the handouts plus video condition played more than one video module. Both groups had significant decreases in maladaptive mealtime parenting practices, undesired child mealtime behaviors, and number of foods offered. No significant effect of study condition was found on the outcome measures. Further research is needed to determine how to encourage engagement of parents with self-administered intervention materials.

Background: Central nervous system (CNS)-directed treatments can cause long-term academic, social, and emotional difficulties for children with cancer. However, limited research has examined the emergence of problems longitudinally and has often stratified risk by diagnosis alone. Therefore, this study compared competence and adjustment in children, who did and did not receive CNS-directed treatment, over the first 3 years following a cancer diagnosis. Procedure: Mothers, fathers, and children (ages 5–18 years at diagnosis) from 217 families reported on the child's competence (academic, social) and adjustment (anxious/depressed, withdrawn/depressed) near a new cancer diagnosis or relapse and 3 years later. Children were categorized into CNS-directed treatment (n = 112; including cranial radiation, intrathecal chemotherapy, and/or neurosurgery) and non-CNS-directed treatment (n = 105) groups. Results: At enrollment, there were few differences in competence and emotional adjustment among children based on treatment or diagnostic group. At 3 years, mothers and fathers reported poorer social competence for the CNS-directed treatment group, and fathers reported poorer school competence for the CNS-directed treatment group. Over time, father ratings of social competence increased for the non-CNS-directed treatment group, but not the CNS-directed treatment group. While father ratings of academic competence declined for the CNS-directed treatment group, mother ratings declined the most for children diagnosed with a brain tumor. All children demonstrated higher anxious/depressed scores over time. Conclusions: CNS-directed treatment may be a valuable indicator to identify childhood cancer survivors at risk for poor competence during early survivorship. Follow-up screening and supportive services are recommended, as well as additional longitudinal research.

PURPOSE: Pediatric cancer survivors may have lower quality of life (QoL), but most research has assessed outcomes either in treatment or long-term survivorship. We focused on early survivorship (i.e., three and five years post-diagnosis), examining the impact of CNS-directed treatment on child QoL, as well as sex and age at diagnosis as potential moderators. METHODS: Families of children with cancer (ages 5–17) were recruited at diagnosis or relapse (N=336). Survivors completed the PedsQL at three (n=96) and five (n=108) years, along with mothers (101 & 105, respectively) and fathers (45 & 53, respectively). The impact of CNS treatment, sex, and age at diagnosis on child QoL was examined over both time since diagnosis and time since last treatment using mixed model analyses. RESULTS: Parent-report of the child’s total QoL was in the normative range and stable between three and five years when examining time since diagnosis, while child reported QoL improved over time (p=0.04). In terms of time since last treatment, mother and child both reported the child’s QoL improved over time (p=0.0002 and p=0.0006, respectively). Based on parent-report, males with CNS-directed treatment had lower total QoL than females and males who did not receive CNS-directed treatment. Age at diagnosis did not moderate the impact of treatment type on total QoL. CONCLUSIONS: QoL in early survivorship may be low among males who received CNS-directed treatment. However, this was only evident on parent-report. Interventions to improve child QoL should focus on male survivors who received CNS-directed treatment, as well as females regardless of treatment type.

Objective Approximately half of male childhood cancer survivors experience impaired fertility, yet fertility preservation (FP) remains underutilized. Although parent recommendation influences adolescents’ decision-making, parents may be uncertain and/or underrate their sons’ parenthood goals. This study assessed parent–adolescent and family-level concordance regarding adolescent fertility perspectives (i.e., values, goals) and associations with FP attempts. Methods A prospective pilot study examined the impact of a family-centered values clarification tool (FAST) on banking attempts among adolescent males newly diagnosed with cancer at risk for infertility. The FAST assessed adolescent and parent perceptions of adolescents’ fertility values and goals (i.e., perceived threat of infertility, perceived benefits/barriers to banking). Parent–adolescent concordance and family-level concordance on fertility perspectives were examined, along with associations with banking attempts and salient demographic factors. Results Ninety-eight participants (32 adolescents aged 12–20, 37 mothers, 29 fathers) from 32 families completed the FAST before treatment initiation. Parent–adolescent dyads were concordant on approximately one-half of responses. Banking attempts were associated with higher family-level concordance regarding perceived benefits, r(32) = .40, p = .02. Older adolescent age was associated with higher family-level concordance regarding perceived threat, r(31) = .37, p = .04, and benefits, r(32) = .40, p = .03. Fathers’ education was associated with higher family-level concordance regarding barriers, r(21) = .53, p = .01. Conclusions When parents were concordant with their son’s fertility values and goals, particularly perceived benefits, adolescents were more likely to attempt FP. Clinicians should facilitate sharing of fertility perspectives within families before cancer treatment, especially with younger adolescents. Psychosocial support for families facing FP decisions is recommended at diagnosis and across the care continuum.

Purpose: Approximately half of all males experience fertility impairment after cancer treatment, which can diminish quality of life. Parents are often responsible for sharing health-related informa...

PURPOSE: Over half of males experience fertility impairment after childhood cancer therapy, which often causes psychosocial distress. Yet, fertility preservation (FP) remains underutilized. The goals of this study were to determine the feasibility and impact of implementing a family-centered FP values clarification tool on sperm banking attempts among adolescent males newly diagnosed with cancer, and identify key determinants of banking attempts. METHODS: A prospective pilot study was conducted among families of males (12–25 years old), prior to cancer therapy. Thirty-nine of 41 families agreed to participate (95%); 98 participants (32 adolescents, 37 mothers, 29 fathers) completed the Family-centered Adolescent Sperm banking values clarification Tool (FAST). Analyses assessed the impact of the FAST on banking attempts and examined associations between demographic/medical characteristics, FAST subscales (perceived threat, benefits, barriers), and banking attempts. RESULTS: Twenty-three (59%) adolescents attempted to bank, compared to 8 adolescents (33%) during baseline assessment (p=.04). Significant associations were identified between banking attempts and adolescents’ report of perceived threat (r(pb)=.45, p=.01) and benefits (r(pb)=.57, p=.01). Only mothers’ proxy reports of adolescent perceived threat (r(pb)=.42, p=.01) and benefits (r(pb)=.47, p=.003) were associated with banking attempts, while fathers’ self-reported perceived benefits (r(pb)=.43, p=.03), self-reported barriers (r(pb)=.49, p=.01), and proxy reports of adolescent perceived threat (r(pb)=.38, p=.04) and benefits (r(pb)=.59, p=.02) were associated with banking attempts. CONCLUSION: Adolescent sperm banking attempt rates significantly increased after implementation of a family-centered FP values clarification tool prior to cancer treatment. Findings underscore the importance of targeting both adolescents and their parents, particularly fathers, in FP efforts.

OBJECTIVE: Little is known about how youth with spina bifida (SB) acquire adaptive functioning skills across development. Therefore, the current study examined: (1) trajectories of adaptive functioning in youth with SB as they transitioned from childhood into adolescence, and (2) neuropsychological functioning as a potential risk factor for long-term adaptive functioning difficulties. METHODS: Participants (n = 131 youth with SB) were recruited as part of a larger ongoing longitudinal study. Growth curves were used to examine changes over time across six adaptive functioning skills: communication, self-direction, functional academics, social, self-care, and home living skills. Additionally, youth’s attention and executive functioning (i.e., working memory, planning/organizational skills, cognitive flexibility, inhibition) were assessed via questionnaires and performance-based assessments, and entered as predictors in the models. RESULTS: Youth’s communication, self-direction, functional academics, self-care, and home living skills increased over time across age, whereas youth’s social skills did not. Scaled scores for youth’s social, communication, self-direction, and functional academics skills were generally within normal limits, whereas those for self-care and home living skills fell in the borderline range. Better attention and executive functioning predicted a higher intercept for many adaptive functioning abilities at 11.5 years old, above and beyond the influence of IQ. However, these variables did not predict growth in adaptive functioning. CONCLUSION: Results indicate that youth with SB acquire skills across development to better meet the demands of daily life. However, youth with poorer neurocognitive functioning may demonstrate adaptive functioning deficits in early childhood and benefit from timely intervention.

Background Because of medical advancements, many congenital heart disease (CHD) survivors are relatively symptom-free until adulthood, at which time complications may occur. Worsening health status likely drives a change in patient-reported outcomes, such as health-related quality of life (HRQoL), although change in HRQoL has not been investigated among adolescent and young adult CHD survivors. Objective The aims of the current mixed cross-sectional and longitudinal study were to (1) examine changes in HRQoL over 3 years and (2) identify any demographic (age, sex, estimated family income, and distance from medical center) and medical predictors (functional status and number of cardiac-related medications) of that change. Methods Baseline and 3-year follow-up data were obtained via an online survey of 172 CHD survivors (15-39 years old at baseline; 25% simple, 45% moderate, 30% complex) recruited from a pediatric hospital and an adult hospital. Medical predictors were abstracted from electronic medical records. Results After controlling for New York Heart Association functional class, mixed-effects models identified significant declines in all subscales of the Research and Development Corporation 36-Item Health Survey 1.0 across the 3-year timeframe. A lower estimated family income (≤$35 000) predicted more decline in physical functioning (b = 0.5, 95% confidence interval, 0.2-0.8; P = .001) and emotional functioning (b = 0.3, 95% confidence interval, 0.1-0.5; P = .017). No other significant demographic or medical predictors were identified. Conclusions Study findings highlight the importance of tracking patient-reported outcomes over time, suggesting that medical staff should discuss HRQoL with CHD survivors during late adolescence and early adulthood before decline.

Objective Suicidal behavior (SB) in young children is rare yet in 2019, suicide was the fifth leading cause of death in 5-12-year-old youth. Understanding the risks associated with childhood suicidal ideation (SI) and SB will determine which factors should be targeted for prevention programming. This study examined clinical characteristics and emotional reactivity/regulation (ERR) in children with (SI+) and without (SI-) SI. Method One hundred seventeen children, 6–9 years, and one biological parent were enrolled. Children completed interviews concerning SI/SB and parents completed interviews/self-reports about SI/SB, psychiatric distress, and history of abuse/neglect and their child's SI/SB, mental health, and ERR. Independent t-tests and Chi-square analyses using Bonferroni correction were conducted to examine SI group differences. Variables were then screened using forward stepwise logistic regression to determine association with SI + status. The final logistic regression included variables that survived screening procedures only. Results Univariate analyses revealed SI + children were more likely to have a parental history of suicide attempt (PH+), higher rates of current psychotropic medication use, higher scores on the CBCL-DSM oriented scales (e.g., ADHD problems), and higher negative affect compared to SI- children. After analytic screening procedures, PH+, anxiety problems, ADHD problems, and anger survived. The final logistic regression revealed PH + status and anxiety problems were associated with SI + status. Conclusion Long-term follow-up is needed to determine if these factors are predictive of a first-time suicide attempt in this at-risk group.

OBJECTIVE Despite calls to increase prognosis communication for adolescents with cancer, limited research has examined their perceptions of prognosis as compared with their parents. We assessed adolescents' understanding of their prognosis relative to parents and oncologists. METHODS Families of adolescents (aged 10-17) were recruited at two pediatric institutions following a new diagnosis or relapse. Seventy-four adolescents, 68 mothers, and 40 fathers participated at enrollment; 76 adolescents, 69 mothers, and 35 fathers participated one year later. The adolescent's primary oncologist reported on prognosis only at enrollment. Participants rated the likelihood of the adolescent's survival in five years, as well as reporting prognosis communication and sources of information. RESULTS Most oncologists (65%) and fathers (63%) discussed prognosis in numerical terms with the adolescent at baseline, which was greater than mother report (49%) of discussions of numerical prognosis with adolescents. Adolescents reported a better prognosis than oncologists, but comparable with mothers at diagnosis and one year. Adolescents' prognosis estimates were stable over time (P > .05). At diagnosis, adolescent-father (P = 0.025) and adolescent-oncologist (P

Background Marijuana is the most-used illicit substance during pregnancy in the USA, but only two cohort studies, begun over 30 years ago, were specifically established to assess the association of pregnancy use with childhood outcomes. They found use to be associated with specific deficits in executive function at 8+ years, but did not focus on these outcomes earlier in life when intervention may be more successful. Two general purpose cohorts found increased aggression in exposed female toddlers and increased behavioural problems and tic disorders in exposed school-age children. Objectives The Lifestyle and Early Achievement in Families (LEAF) study assesses the association of in utero marijuana exposure, documented prospectively by biomarker, self-report, and medical records, with executive function and aggression at age 3½-7 years. Methods This ambidirectional cohort (historical cohort with continued follow-up) includes women enrolled in the Perinatal Research Repository during prenatal care at Ohio State University Wexner Medical Center and their children, recontacted 3½-7 years post-birth. Children complete 1-2 study visits including cognitive testing, behavioural observation, and maternal and teacher report of behaviour. Family and social environmental factors are assessed. Results Child follow-up began in September 2016; visits continue through August 2020. There are 362 eligible children; 32% had mothers who used marijuana during pregnancy, 10% of mothers completed college, and 23% did not complete high school. Mean maternal age at study registration in pregnancy was 26.4 years, and 63% of mothers were African American. To date, 268 children have completed at least 1 study visit. Conclusions The LEAF Study will document the association of prenatal marijuana exposure with development and behaviour in the current era when marijuana is more potent than when previous cohorts were studied. The results may inform policy and interventions to counsel reproductive-aged women about the risks of use during pregnancy and guide prevention and treatment of adverse effects among children.

Background/AimsThe Intent to Attend is a brief questionnaire recommended by the National Research Council to address dropout concerns and improve prediction of missing data in clinical trials, although implementation has been very limited. As a formative study in pediatric research, the relationship between caregiver intentions and study compliance was investigated in a 180-day trial of dietary supplementation of preterm toddlers. Treatment effect estimation in the context of missing data was also explored.MethodsStudy compliance (i.e. study completion, supplement adherence, and diary completion) was tracked over three study visits. Baseline questionnaires asked caregivers about intentions concerning study completion via the Intent to Attend, screened for mental health symptoms (depression, trait anxiety), and captured family demographics. Simple and multiple logistic regression models were built to examine associations between caregiver intent and compliance outcomes. The Intent to Attend was also employed as an auxiliary variable to account for missing data within mixed models estimating the treatment effect on the primary outcomes.ResultsOf the 316 caregiver–child dyads included, 95% of caregivers with low intentions had a child complete the study, but only 87% of caregivers with high intentions had a child complete the study. Low intentions to complete the study were associated with a more than 60% lower odds of study non-completion, but the confidence interval included the null (odds ratio: 0.36; 95% confidence interval: 0.11, 1.20). No effect measure modification by caregiver mental health, child sex, or annual income was detected. Income was the only significant predictor of study non-completion; the lowest income group was almost four times more likely to be study non-completers compared with the highest income group, even after adjustment for child sex and caregiver mental health (adjusted odds ratio = 3.59, 95% confidence interval: 1.38, 9.31). When using Intent to Attend as an auxiliary variable, similar results were obtained when compared with the original treatment effect estimates on the primary outcomes.ConclusionContrary to prior adult studies, there is no clear relationship between caregiver intentions and study compliance. Findings elucidate the complexities of caregiver–child interactions during pediatric trial participation.

OBJECTIVE The majority of childhood cancer survivors develop at least one late effect subsequent to treatment (eg, cardiovascular disease and obesity). Consistent engagement in recommended health behaviors may mitigate some of these conditions. Researchers have identified early survivorship as a teachable moment, yet few studies have examined positive health behaviors during this period. METHODS Families of children with cancer (ages 5-17) were initially recruited following a diagnosis or relapse of cancer. Three years post diagnosis, survivors (n = 82, Mage = 13.3, SD = 3.7) and their mothers (n = 103, Mage = 41.1, SD = 7.6) completed a questionnaire assessing exercise, dietary, and sleep patterns among survivors. A follow-up assessment was conducted 2 years later. Mixed models tested change in health behavior over time. RESULTS At 3- and 5-year post diagnosis, mother and self-report indicated that few survivors engaged in appropriate levels of low-intensity exercise, fruit/vegetable intake, and dairy consumption. However, most survivors engaged in recommended levels of high intensity exercise, fast food restriction, and sleep. Health behaviors remained stable over time, except for mother report of sleep duration, which decreased (b = -0.6, P

We prospectively examined rates of outpatient oral medication adherence in children after hematopoietic stem cell transplant (post-HSCT). For 6 months after first discharge post-HSCT, 50 patients (aged 0 to 16 years) and their primary caregivers agreed to store 1 oral medication in an electronic pill bottle that date and time stamps each bottle opening. Demographics, disease, donor type, and prescribed post-HSCT medication regimen were collected via chart review. For each patient percent adherence was calculated by dividing the number of doses taken as indicated by the electronic pill bottle by the number of doses prescribed for the same time period. Average percent adherence ranged from 63% at 1 month after discharge to 57% at 6 months after discharge. For patients who received an allogeneic transplant, lower adherence was associated (P .005) with higher infection rates, after controlling for age and time since transplant. No such relationship was observed for patients who received an autologous transplant. This study demonstrates that poor oral medication adherence is prevalent, persistent, and, for patients receiving an allogeneic transplant, associated with increased incidence of infections during the outpatient treatment period. This study highlights the need for further research examining factors that hinder medication adherence as well as monitoring, promoting, and intervening to maximize medication adherence throughout the HSCT course.

Background Children born preterm are at increased risk of autism spectrum disorder (ASD). n-3 (ω-3) Combined with n-6 (ω-6) fatty acids including γ-linolenic acid (GLA) may benefit children born preterm showing early signs of ASD. Previous trials have reported that docosahexaenoic acid (DHA) promotes cognitive development in preterm neonates and n-3 fatty acids combined with GLA improve attention-deficit-hyperactivity disorder. Objectives The objectives of the pilot Preemie Tots Trial were 1) to confirm the feasibility of a full-scale trial in toddlers born very preterm and exhibiting ASD symptoms and 2) to explore the effects of supplementation on parent-reported ASD symptoms and related behaviors. Methods This was a 90-d randomized, fully blinded, placebo-controlled trial in 31 children 18-38 mo of age who were born at ≤29 wk of gestation. One group was assigned to daily Omega-3-6-9 Junior (Nordic Naturals, Inc.) treatment (including 338 mg eicosapentaenoic acid, 225 mg DHA, and 83 mg GLA), and the other group received canola oil (124 mg palmitic acid, 39 mg stearic acid, 513 mg linoleic acid, 225 mg α-linolenic acid, and 1346 mg oleic acid). Mixed-effects regression analyses followed intent-to-treat analysis and explored effects on parent-reported ASD symptoms and related behaviors. Results Of 31 children randomly assigned, 28 had complete outcome data. After accounting for baseline scores, those assigned to treatment exhibited a greater reduction in ASD symptoms per the Brief Infant Toddler Social Emotional Assessment ASD scale than did those assigned to placebo (difference in change = - 2.1 points; 95% CI: - 4.1, - 0.2 points; standardized effect size = - 0.71). No other outcome measure reflected a similar magnitude or a significant effect. Conclusions This pilot trial confirmed adequate numbers of children enrolled and participated fully in the trial. No safety concerns were noted. It also found clinically-significant improvements in ASD symptoms for children randomly assigned to receive Omega-3-6-9 Junior, but effects were confined to one subscale. A future full-scale trial is warranted given the lack of effective treatments for this population. This trial was registered at www.clinicaltrials.gov as NCT01683565.

Background Despite advances in the health and long-term survival of infants born preterm, they continue to face developmental challenges including higher risk for autism spectrum disorder (ASD) and atypical sensory processing patterns. Aims This secondary analysis aimed to describe sensory profiles and explore effects of combined dietary docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), and gamma-linolenic acid (GLA) supplementation on parent-reported sensory processing in toddlers born preterm who were exhibiting ASD symptoms. Study design 90-day randomized, double blinded, placebo-controlled trial. Subjects 31 children aged 18–38 months who were born at ≤ 29 weeks' gestation. Outcome measure Mixed effects regression analyses followed intent to treat and explored effects on parent-reported sensory processing measured by the Infant/Toddler Sensory Profile (ITSP). Results Baseline ITSP scores reflected atypical sensory processing, with the majority of atypical scores falling below the mean. Sensory processing sections: auditory (above = 0%, below = 65%), vestibular (above = 13%, below = 48%), tactile (above = 3%, below = 35%), oral sensory (above = 10%; below = 26%), visual (above = 10%, below = 16%); sensory processing quadrants: low registration (above = 3%; below = 71%), sensation avoiding (above = 3%; below = 39%), sensory sensitivity (above = 3%; below = 35%), and sensation seeking (above = 10%; below = 19%). Twenty-eight of 31 children randomized had complete outcome data. Although not statistically significant ( p = 0.13), the magnitude of the effect for reduction in behaviors associated with sensory sensitivity was medium to large (effect size = 0.57). No other scales reflected a similar magnitude of effect size (range: 0.10 to 0.32). Conclusions The findings provide support for larger randomized trials of omega fatty acid supplementation for children at risk of sensory processing difficulties, especially those born preterm.

Objectives To examine parent-child communication (i.e., openness, problems) and child adjustment among youth with advanced or non-advanced cancer and comparison children. Methods Families (n = 125) were recruited after a child's diagnosis/relapse and stratified by advanced (n = 55) or non-advanced (n = 70) disease. Comparison children (n = 60) were recruited from local schools. Children (ages 10-17) reported on communication (Parent-Adolescent Communication Scale) with both parents, while mothers reported on child adjustment (Child Behavior Checklist) at enrollment (T1) and one year (T2). Results Openness/problems in communication did not differ across groups at T1, but problems with fathers were higher among children with non-advanced cancer versus comparisons at T2. Openness declined for all fathers, while changes in problems varied by group for both parents. T1 communication predicted later adjustment only for children with advanced cancer. Conclusions Communication plays an important role, particularly for children with advanced cancer. Additional research with families affected by life-limiting conditions is needed.

Delayed language development may be an early indicator of autism spectrum disorder (ASD). Early intervention is critical for children with ASD, and the present study presents pilot data on a clinical trial of omega-3 and -6 fatty acid supplementation and language development, a secondary trial outcome, in children at risk for ASD. We randomized 31 children to receive an omega-3 and -6 supplement or a placebo for 3 months, and measured their language abilities at baseline and after supplementation. Gesture use, but not word production, increased for children in the treatment group more than children in the placebo group. These results suggest possible effectiveness of omega-3 and -6 supplementation for language development in children at risk for ASD.

STUDY OBJECTIVES: This secondary analysis characterized sleep patterns for toddlers born preterm and tested effects of docosahexaenoic acid (DHA)+ arachidonic acid (AA) supplementation on children’s caregiver-reported sleep. Exploratory analyses tested whether child sex, birth weight, and caregiver depressive symptomatology were moderators of the treatment effect. METHODS: Omega Tots was a single-site 180-day randomized (1:1), double-blinded, placebo-controlled trial. Children (n = 377) were age 10 to 16 months at enrollment, born at less than 35 weeks’ gestation, assigned to 180 days of daily 200 mg DHA + 200 mg AA supplementation or placebo (400 mg corn oil), and followed after the trial ended to age 26 to 32 months. Caregivers completed a sociodemographic profile and questionnaires about their depressive symptomatology (Center for Epidemiologic Studies Depression Scale) and the child’s sleep (Brief Infant Sleep Questionnaire). Analyses compared changes in sleep between the DHA+AA and placebo groups, controlling for baseline scores. Exploratory post hoc subgroup analyses were conducted. RESULTS: Eighty-one percent (n(tx) = 156; n(placebo) = 150) of children had 180-day trial outcome data; 68% (n(tx) = 134; n(placebo) = 122) had postintervention outcome data. Differences in change between the DHA+AA and placebo groups after 180 days of supplementation were not statistically significant for the entire cohort. Male children (difference in nocturnal sleep change = 0.44, effect size = 0.26, P = .04; sleep problems odds ratio = 0.36, 95% confidence interval = 0.15, 0.82) and children of depressed caregivers (difference in nocturnal sleep change = 1.07, effect size = 0.65, P = .006; difference in total sleep change = 1.10, effect size = 0.50, P = .04) assigned to the treatment group showed improvements in sleep, compared to placebo. CONCLUSIONS: Although there is no evidence of an overall effect of DHA+AA supplementation on child sleep, exploratory post hoc analyses identified important subgroups of children born preterm who may benefit. Future research including larger samples is warranted. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Identifier: NCT01576783 CITATION: Boone KM, Rausch J, Pelak G, Li R, Turner AN, Klebanoff MA, Keim SA. Docosahexaenoic acid and arachidonic acid supplementation and sleep in toddlers born preterm: secondary analysis of a randomized clinical trial. J Clin Sleep Med. 2019;15(9):1197–1208.

BACKGROUND AND OBJECTIVES: Many adolescents with type 1 diabetes experience diabetes-related distress (DRD; the negative emotional reactions specific to managing diabetes), but most research on DRD among adolescents relies on cross-sectional data. We assess adolescents’ longitudinal DRD patterns and predictors of chronic DRD. METHODS: This secondary analysis of data from a depression prevention clinical trial included 264 adolescents with type 1 diabetes randomly assigned to a resilience or education intervention (mean age: 15.7 ± 1.1 years; 59.8% female). Youth reported their DRD at 5 assessments over 16 months. Using latent class growth analysis, we classified adolescents into trajectory groups according to baseline starting point (intercept) and rate of change (slope) of DRD. We examined bivariate associations between trajectory group membership and demographic and clinical factors. Baseline predictors of chronic DRD were assessed via multiple logistic regression. RESULTS: Participants were classified into 4 groups: stable high DRD (7.2%; high intercept, flat slope), stable moderate DRD (28.0%; above-average intercept, flat slope), improving DRD (33.7%; average intercept, downward slope), and low DRD (31.1%; below-average intercept, downward slope). Lower hemoglobin A1c, greater adherence, fewer socioemotional difficulties, and more adaptive coping distinguished the improving and low DRD trajectories. Chronic DRD patterns were associated with female sex and higher depressive symptoms and hemoglobin A1c. CONCLUSIONS: In this study of adolescents’ DRD trajectories during and after a psychoeducational intervention, one-third of youth were classified as having chronic, elevated DRD. Links with multiple clinical factors support efforts for routine DRD screening and comprehensive interventions for distressed youth.

Key Points Question Does the disproportionate increase in suicide rates among female youth indicate a narrowing of the historically large gap between male and female youth in suicide? Findings This cross-sectional study of 85 051 youth suicide deaths found a significant reduction in the gap between male and female rates of suicide among youth aged 10 to 19 in the United States, with the most pronounced narrowing in younger individuals. Female suicide rates by hanging or suffocation are approaching those of male youth, and significant differences by race/ethnicity also exist. Meaning A narrowing gap between male and female youth suicide rates underscores the importance of early suicide prevention efforts that take both sex and developmental level into consideration., This cross-sectional study investigates trends in suicide rates among US youth aged 10 to 19 years by sex, age group, race/ethnicity, and method of suicide., Importance Suicide is a leading cause of death among youth aged 10 to 19 years in the United States, with rates traditionally higher in male than in female youth. Recent national mortality data suggest this gap may be narrowing, which warrants investigation. Objective To investigate trends in suicide rates among US youth aged 10 to 19 years by age group, sex, race/ethnicity, and method of suicide. Design, Setting, and Participants Cross-sectional study using period trend analysis of US suicide decedents aged 10 to 19 years from January 1, 1975, to December 31, 2016. Data were analyzed for periods defined by statistically significant changes in suicide rate trends. Suicide rates were calculated using population estimates. Main Outcomes and Measures Period trends in suicide rates by sex and age group were assessed using joinpoint regression. Incidence rate ratios (IRRs) were estimated using negative binomial regression comparing male and female suicide rates within periods. Results From 1975 to 2016, we identified 85 051 youth suicide deaths in the United States (68 085 male [80.1%] and 16 966 female [19.9%]) with a male to female IRR of 3.82 (95% CI, 3.35-4.35). Following a downward trend until 2007, suicide rates for female youth showed the largest significant percentage increase compared with male youth (12.7% vs 7.1% for individuals aged 10-14 years; 7.9% vs 3.5% for individuals aged 15-19 years). The male to female IRR decreased significantly across the study period for youth aged 10 to 14 years (3.14 [95% CI, 2.74-3.61] to 1.80 [95% CI, 1.53-2.12]) and 15 to 19 years (4.15 [95% CI, 3.79-4.54] to 3.31 [95% CI, 2.96-3.69]). Significant declining trends in the male to female IRR were found in non-Hispanic white youth aged 10 to 14 years (3.27 [95% CI, 2.68-4.00] to 2.04 [95% CI, 1.45-2.89]) and non-Hispanic youth of other races aged 15 to 19 years (4.02 [95% CI, 3.29-4.92] to 2.35 [95% CI, 2.00-2.76]). The male to female IRR for firearms increased significantly for youth aged 15 to 19 years (χ2 = 7.74; P = .02 for sex × period interaction). The male to female IRR of suicide by hanging or suffocation decreased significantly for both age groups (10-14 years: χ2 = 88.83; P

Self-administered treatments may overcome access barriers to evidence-based care for pediatric sleep problems. Two hundred thirty-nine families participated in a randomized controlled trial with 3 study arms: a DVD intervention condition (the Sleep Easy Solution), a Website comparison condition, and a Wait-List comparison condition. The primary outcome was trichotomous—Do you consider your child’s sleep a problem? (not a problem at all, a small problem, a very serious problem). DVD was superior to Wait-List in terms of the primary outcome ( P = .03; odds ratio = 0.44; 95% confidence interval = 0.21-0.93). Similarly, regarding secondary outcomes, DVD was superior to Wait-List in terms of longer continuous sleep periods ( P = .003), more favorable perceptions of the child’s overall sleep ( P = .001), and higher parental confidence in managing the child’s sleep ( P = .001). Results suggest that the DVD intervention is a promising self-administered treatment for pediatric insomnia.

Purpose The purpose of this study was to examine patterns of adherence to a novel dietary supplement in pediatric cystic fibrosis. Adherence to dietary supplementation in cystic fibrosis is challenging, and examination of patterns of adherence behavior over time is needed to better characterize subgroups of patients who need self-management support. Design and methods We prospectively examined adherence to Lym-X-Sorb™ (LXS), an organized lipid matrix dietary supplementation for patients with cystic fibrosis (CF) and pancreatic insufficiency (PI), over a 12-month period. Adherence for participants aged 5–17 years with CF and PI (N = 109) was monitored monthly via supplement packet counts. Group-based trajectory modeling was employed to examine patterns in adherence behavior over time. Results Four distinct trajectories best characterized adherence in this sample, with 18% of participants demonstrating near perfect adherence, 42% demonstrating good adherence (at or above 80%), 16% demonstrating poor adherence that declined over time, and 24% demonstrating significant non-adherence ( Conclusions Some patients with CF and PI who are prescribed nutritional supplements will require intensive, individualized behavioral intervention to enhance adherence. Identifying patients who will have difficulty adhering to dietary interventions may result in better treatment-to-patient matching and improved adherence promotion efforts. Practice Implications. Assessment of adherence to dietary supplementation over time can identify patients at risk for continued difficulty with self-management and provide opportunities for early intervention.

Background Advances in hematopoietic stem cell transplantation (HSCT) have contributed to increased survival for pediatric patients. However, there are inconsistent findings regarding the impact of HSCT on health-related quality of life (HRQOL) outcomes for children. This study aimed to establish trajectories of HRQOL following HSCT and identify predictors of the HRQOL course. Procedure Ninety caregivers of a child who received HSCT (mean age = 6.42 years) for various oncologic, immunologic, and metabolic conditions completed questionnaires regarding family psychosocial functioning and child HRQOL at the time of discharge from HSCT and follow-up HRQOL at four additional time points. Results There was a significant change in overall HRQOL in 3 months postdischarge, with the greatest improvement in physical functioning. Caregiver stress and social support, and child psychosocial problems predicted changes in HRQOL over time. Conclusions These results point to potentially modifiable factors that are related to the course of HRQOL following HSCT, and interventions aimed at these factors should be implemented.

A dearth of research exists examining provider adherence to preventative health care guidelines at adolescent well-care visits. We examined adherence in 3 domains: documentation of sexual activity, documentation of menstrual characteristics, and administration of the human papillomavirus vaccine. We identified electronic health records of a random sample of 124 adolescent girls seen within the hospital-affiliated pediatric primary care clinics from July 1, 2014, to June 30, 2015. Approximately one quarter of the records examined had no documentation of sexual activity. Documentation occurred more frequently in English speakers ( P = .003). Asian girls had the least documentation of sexual activity ( P = .003). Clinicians documented menses characteristics in only 27% of adolescent girls with no documentation noted for Asian adolescents. Over 40% of eligible adolescents did not receive the human papillomavirus vaccine. Only 19.4% of adolescents received all the 3 recommended services. This study demonstrates that adolescent girls are not receiving recommended assessments or care to protect their reproductive health.

OBJECTIVE The aim is to report 1-year outcomes of the Supporting Teens Problem Solving (STePS) study, a randomized controlled trial comparing a distress and depression prevention program with a diabetes education program for adolescents with type 1 diabetes. RESEARCH DESIGN AND METHODS With 264 adolescents in two locations (Chicago and San Francisco Bay Area), a randomized controlled trial was conducted comparing the Penn Resilience Program for type 1 diabetes (PRP T1D) to Advanced Diabetes Education. Interventions lasted 4.5 months, and assessments were conducted at baseline, and 4.5, 8, 12, and 16 months. Outcomes of interest were diabetes distress (DD), depressive symptoms, resilience, diabetes self-management, and glycemic control. Latent growth curve modeling was used to test between-group differences over time. RESULTS Results indicate that there was acceptable randomization and exposure to interventions, and that exposure to PRP T1D was associated with substantial reductions in DD. In addition, stable glycemic control, resilience characteristics, and depressive symptoms were observed 1 year post-treatment. Diabetes management deteriorated in both groups. CONCLUSIONS Intervening before symptoms of psychological distress start can prevent the development of the DD commonly seen in adolescents with type 1 diabetes. The STePS program represents a promising prevention program, and future reports on 2- and 3-year outcomes will explore benefits over longer periods of time.

Objective Examine friendship qualities (i.e., control, prosocial skills, positive affect, support, companionship, conflict, help, security, and closeness) and perceived self-efficacy in friendships of children with spina bifida (SB) and chosen peers over time through observed behaviors and self-report. Methods Families of children with SB (aged 8-15) were asked to invite the child's "best friend" to participate in-home assessment visits; 127 friendship dyads were included in the current study. Mixed-effects models were used to examine children with SB and their peers across age on observed behaviors and self-reported data about their friendships. Results For observed behaviors, peers displayed more control (p = .002) and prosocial behaviors (p = .007) with age than youth with SB. Male peers displayed higher control in their interactions as they aged (p = .04); and males with SB maintained their level of prosocial behaviors with age, compared to an increase in prosocial behaviors with age for all other groups (p = .003). For self-reported data, there was no evidence to suggest significant differences in friendship qualities across age (ps ≥ .2), with the exception of increased help (p = .002). Female peers reported increases in companionship across age compared to the other groups (p = .04). Conclusions Differing from previous examinations of social characteristics in SB, most longitudinal trends in friendship qualities did not differ for youth with SB compared to their peers. Promotion of this existing social strength may be a key intervention target for future strategies that promote positive outcomes for youth with SB.

BACKGROUND: Despite advances in the health and long-term survival of infants born preterm, they continue to face developmental challenges including higher risk for autism spectrum disorder (ASD) and atypical sensory processing patterns. AIMS: This secondary analysis aimed to describe sensory profiles and explore effects of combined dietary docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), and gamma-linolenic acid (GLA) supplementation on parent-reported sensory processing in toddlers born preterm who were exhibiting ASD symptoms. STUDY DESIGN: 90-day randomized, double blinded, placebo-controlled trial. SUBJECTS: 31 children aged 18–38 months who were born at ≤ 29 weeks’ gestation. OUTCOME MEASURE: Mixed effects regression analyses followed intent to treat and explored effects on parent-reported sensory processing measured by the Infant/Toddler Sensory Profile (ITSP). RESULTS: Baseline ITSP scores reflected atypical sensory processing, with the majority of atypical scores falling below the mean. Sensory processing sections: auditory (above = 0%, below = 65%), vestibular (above = 13%, below = 48%), tactile (above = 3%, below = 35%), oral sensory (above = 10%; below = 26%), visual (above = 10%, below = 16%); sensory processing quadrants: low registration (above = 3%; below = 71%), sensation avoiding (above = 3%; below = 39%), sensory sensitivity (above = 3%; below = 35%), and sensation seeking (above = 10%; below = 19%). Twenty-eight of 31 children randomized had complete outcome data. Although not statistically significant (p = 0.13), the magnitude of the effect for reduction in behaviors associated with sensory sensitivity was medium to large (effect size = 0.57). No other scales reflected a similar magnitude of effect size (range: 0.10 to 0.32). CONCLUSIONS: The findings provide support for larger randomized trials of omega fatty acid supplementation for children at risk of sensory processing difficulties, especially those born preterm.

Objective Childhood obesity remains a significant health issue, especially in disparate populations and during the summer months, when millions of children lose access to school-based feeding programs and suffer gaps in meals. The objective of this study was to measure the efficacy of a three-month garden-based summer intervention targeting low-resource youth. Description Summer Harvest Adventure (SHA) is a five-year randomized controlled trial targeting children and parent/adult caregivers (PAC). In year one (of three), a total of 72 children (ages 8-11 years) were randomized to a garden-based intervention or enhanced control group. The intervention consisted of theoretical-driven and evidence-based group education, produce (fruits, vegetables, and herbs) harvesting, cooking demonstrations, remote motivational interviewing, and e-technologies. Data collected at baseline (month zero) and post-intervention (month three) included sociodemographics, quality of life, dietary patterns, family dynamics, program satisfaction; anthropometrics, body composition, physical activity, cardiovascular risk, and skin carotenoids were measured objectively. Evaluation Sixty-four percent of SHA participants met study adherence criteria (> 75% attendance). The mean age of enrolled was 8.7 (+/- 0.47) years with 50% male and 57% African American or mixed race. Over 90% of SHA participants rated SHA as “excellent or very good.” Compared to controls, SHA youth exhibited greater improvements in FV intake, physical activity, quality of life, family relationships, skin carotenoids, and carotid intimal thickness. Statistically significant improvements were seen in blood pressure and visceral adiposity (both P Conclusion and Implications Powered for three years, this project will continue to evaluate the impact of SHA in promoting an anti-obesogenic environment for low-resource families during the summer months. Information gleaned from this project will be used to empower families and to establish a summer obesity prevention model for youth, built upon replicable criteria that can be implemented on a national scale.

Importance Intake of dietary docosahexaenoic acid (DHA) among toddlers is low. Supplementation may benefit developmental outcomes of toddlers who were born preterm. Objective To determine whether 6 months of daily DHA supplementation improves developmental outcomes of toddlers who were born preterm. Design, Setting, and Participants A randomized, fully masked, placebo-controlled trial was conducted from April 26, 2012, to March 24, 2017, at a large US pediatric academic center with 9 neonatal intensive care units. Children born at less than 35 weeks’ gestation who were 10 to 16 months corrected age underwent 6 months of intervention. Of 4142 children assessed, 1549 were eligible, 1172 declined, and 377 enrolled and were randomized. Analyses were according to intent to treat. Interventions One-to-one allocation to receive daily microencapsulated DHA, 200 mg, and arachidonic acid (AA), 200 mg (DHA+AA), or microencapsulated corn oil (placebo). Main Outcomes and Measures The primary outcome specified a priori was Bayley Scales of Infant and Toddler Development, third edition (Bayley-III), cognitive composite score at 16 to 22 months corrected age. Secondary outcomes were Bayley-III language and motor composite scores and Infant Behavior Questionnaire–Revised and Early Childhood Behavior Questionnaire effortful control and activity level scores. Subgroup analyses defined a priori were by income, sex, and birth weight. Results Among 377 children randomized and included in the analysis (182 girls and 195 boys; median corrected age, 15.7 months), 338 children (89.7%) had complete data on the primary outcome. Bayley-III cognitive scores did not differ between the DHA+AA and placebo groups (difference in change, 0.5 [95% CI, –1.8 to 2.8]; effect size, 0.05;P = .66). Assignment to the DHA+AA group had a small to medium negative effect on Bayley-III language scores among children with lower birth weights (eg, a child with a birth weight of 1000 g assigned to receive DHA+AA experienced a 4.1-point relative decrease, while a child assigned to placebo did not;P = .03 for interaction). Supplementation had a similar negative effect on effortful control scores among children with annual household incomes greater than $35 000 (difference in change, –0.3 [95% CI, –0.4 to –0.1]; effect size, –0.37;P = .01). Bayley-III motor scores and activity level scores were unaffected. Conclusions and Relevance Daily supplementation with 200 mg of DHA and 200 mg of AA for 6 months resulted in no improvement in cognitive development and early measures of executive function vs placebo, and may have resulted in negative effects on language development and effortful control in certain subgroups of children. These findings do not support DHA supplementation in the second year of life for children who are born preterm. Trial Registration ClinicalTrials.gov Identifier:NCT01576783

Adolescents with type 1 diabetes have an increased risk for a variety of emotional and behavioral challenges as well as negative diabetes outcomes. This study was designed to compare the effectiveness of a depression-prevention, resilience promotion program with an advanced diabetes education program. Each program consisted of 9 group-based sessions. There were 264 adolescents enrolled in this multi-site randomized clinical trial. The primary outcomes were depressive symptoms and glycemic control; secondary outcomes included resilience skills, diabetes management and adherence, and diabetes-specific distress. The goal of the present paper is to describe the study design, the intervention, and the baseline characteristics of the sample. Preliminary data suggests that enrollment, randomization and retention were successful. Longitudinal follow-up and examination of mechanisms of action as they relate to psychosocial and glycemic outcomes will be explored in the future.

OBJECTIVE To identify two-year trajectories of health-related quality of life (HRQOL) among children with newly diagnosed epilepsy, and evaluate key predictors of HRQOL trajectories. METHODS This study is part of a prospective study of adherence and HRQOL outcomes in children with epilepsy. Caregivers completed an HRQOL questionnaire at one month post diagnosis and every three months thereafter for two years. Chart review and additional questionnaires were used to collect medical variables and seizure outcomes. RESULTS Participants included 120 children with epilepsy and their caregiver. Unique trajectories for overall HRQOL and PedsQL™ subscales were identified and were predominantly stable. A total side effects score emerged as a consistent predictor of all HRQOL domains. Other variables (i.e., socioeconomic status, seizures, internalizing and externalizing problems) uniquely predicted HRQOL domains. CONCLUSIONS Medical and psychosocial interventions should be implemented soon after treatment initiation to target modifiable factors (e.g., side effects, anxiety symptoms), which could improve HRQOL.

Pediatric Crohn's Disease (CD) is associated with low trabecular bone mineral density (BMD), cortical area, and muscle mass. Low-magnitude mechanical stimulation (LMMS) may be anabolic. We conducted a 12-month randomized double-blind placebo-controlled trial of 10 minutes daily exposure to LMMS (30 Hz frequency, 0.3 g peak-to-peak acceleration). The primary outcomes were tibia trabecular BMD and cortical area by peripheral quantitative CT (pQCT) and vertebral trabecular BMD by QCT; additional outcomes included dual-energy X-ray absorptiometry (DXA) whole body, hip and spine BMD, and leg lean mass. Results were expressed as sex-specific Z-scores relative to age. CD participants, ages 8 to 21 years with tibia trabecular BMD25th percentile for age, were eligible and received daily cholecalciferol (800 IU) and calcium (1000 mg). In total, 138 enrolled (48% male), and 121 (61 active, 60 placebo) completed the 12-month trial. Median adherence measured with an electronic monitor was 79% and did not differ between arms. By intention-to-treat analysis, LMMS had no significant effect on pQCT or DXA outcomes. The mean change in spine QCT trabecular BMD Z-score was +0.22 in the active arm and -0.02 in the placebo arm (difference in change 0.24 [95% CI 0.04, 0.44]; p = 0.02). Among those with50% adherence, the effect was 0.38 (95% CI 0.17, 0.58, p0.0005). Within the active arm, each 10% greater adherence was associated with a 0.06 (95% CI 0.01, 1.17, p = 0.03) greater increase in spine QCT BMD Z-score. Treatment response did not vary according to baseline body mass index (BMI) Z-score, pubertal status, CD severity, or concurrent glucocorticoid or biologic medications. In all participants combined, height, pQCT trabecular BMD, and cortical area and DXA outcomes improved significantly. In conclusion, LMMS was associated with increases in vertebral trabecular BMD by QCT; however, no effects were observed at DXA or pQCT sites. © 2016 American Society for Bone and Mineral Research.