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Little is known about the factors African American parents consider when seeking care for their child after emotional and behavioral difficulties emerge. This study aimed to examine factors associated with seeking professional care within 30 days after identifying a child's need (i.e., rapid care seeking) and with deferring care for ≥1 year.This cross-sectional study surveyed African American parents raising a child with emotional or developmental challenges (N=289). Logistic regression was used to examine associations of parent activation, medical mistrust, and care-seeking barriers with two outcomes: rapidly seeking care and deferring care seeking.About 22% of parents rapidly sought care, and 49% deferred care for 1 year or longer. Parents were more likely to rapidly seek care if they had higher parent activation scores; lived with other adults with mental health challenges; or, contrary to the authors' hypothesis, mistrusted doctors. Parents were less likely to rapidly seek care if the challenge did not initially bother them much or if their health insurance would not cover the service. Parents were more likely to defer care if they feared involuntary hospitalization for their child or if their health insurance would not cover the service. Parents were less likely to defer care if they had at least some college education or lived with other adults with mental health challenges.Community-based pediatric and child welfare professionals should be informed about facilitators and barriers to mental health care seeking as part of efforts to develop interventions that support African American families.

Attention-deficit/hyperactivity disorder (ADHD) symptoms affect 40-60% of autistic children and have been linked to differences in adaptive behavior. It is unclear whether adaptive behavior in autistic youth is directly impacted by co-occurring ADHD symptoms or by another associated feature of both autism and ADHD, such as increased irritability. The current study examined relationships between irritability, ADHD symptoms, and adaptive behavior in 3- to 7-year-old autistic children. Results suggest that, after adjusting for co-occurring ADHD symptoms, higher levels of irritability are associated with differences in social adaptive behavior specifically. Understanding relationships between irritability, ADHD, and adaptive behavior in autistic children is critical because measures of adaptive behavior, such as the Vineland Scales of Adaptive Functioning, are often used as a proxy for global functioning, as well as for developing intervention plans and measuring outcomes as primary endpoints in clinical trials.

Background: Youth treated with antipsychotic medications are high risk for weight gain, increased lipids/glucose, and development of metabolic syndrome. Little is known about the dietary intake/nutritional adequacy in this vulnerable population, and effect on weight gain. This secondary data analysis describes the baseline intake and changes in diet after receiving healthy lifestyle education/counseling over 6 months, in a sample of youth with antipsychotic-induced weight gain. Methods: The U.S. Department of Agriculture (USDA) Automated Multiple-Pass Method 24-hour dietary recall was administered to 117 youth at baseline, 3 months, and 6 months. Parent/child received personalized healthy lifestyle education sessions over 6 months. Baseline intake was compared with the USDA Recommended Daily Allowance using independent samples t-tests. Individual dietary covariates were examined for change over 6 months using longitudinal linear mixed modeling. Influence of each on body mass index (BMI) z-score change was tested in a pooled group analysis and then compared by treatment group. Results: Pooled analysis revealed baseline consumption high in carbohydrates, fat, protein, sugar, and refined grains, while low in fruit/vegetables, whole grains, fiber, and water. Change over 6 months demonstrated a statistically significant decrease in daily calories (p = 0.002), carbohydrates (p = 0.003), fat (p = 0.012), protein (p = 0.025), sugar (p = 0.008), refined grains (p = 0.008), total dairy (p = 0.049), and cheese (p = 0.027). Small increases in fruits/vegetables were not statistically significant, although the Healthy Eating Index subscores for total vegetables (p = 0.013) and dark green/orange vegetables (p = 0.034) were. No dietary covariates were predictors of change in BMI z-score. Nondietary predictors were parent weight/BMI and treatment group, with the metformin and switch groups experiencing significant decreases in BMI z-score. Conclusions: Further pediatric studies are necessary to assess the effects of antipsychotic medications on dietary intake, and test efficacy of healthy lifestyle interventions on change in nutrition. The relationship of nutrition to cardiometabolic health in this population must be further investigated. Clinical Trial Registration number: NCT 02877823.

Oxytocin (OT), the brain's most abundant neuropeptide, plays an important role in social salience and motivation. Clinical trials of the efficacy of OT in autism spectrum disorder (ASD) have reported mixed results due in part to ASD's complex etiology. We investigated whether genetic and epigenetic variation contribute to variable endogenous OT levels that modulate sensitivity to OT therapy. To carry out this analysis, we integrated genome-wide profiles of DNA-methylation, transcriptional activity, and genetic variation with plasma OT levels in 290 participants with ASD enrolled in a randomized controlled trial of OT. Our analysis identified genetic variants with novel association with plasma OT, several of which reside in known ASD risk genes. We also show subtle but statistically significant association of plasma OT levels with peripheral transcriptional activity and DNA-methylation profiles across several annotated gene sets. These findings broaden our understanding of the effects of the peripheral oxytocin system and provide novel genetic candidates for future studies to decode the complex etiology of ASD and its interaction with OT signaling and OT-based interventions. LAY SUMMARY: Oxytocin (OT) is an abundant chemical produced by neurons that plays an important role in social interaction and motivation. We investigated whether genetic and epigenetic factors contribute to variable OT levels in the blood. To this, we integrated genetic, gene expression, and non-DNA regulated (epigenetic) signatures with blood OT levels in 290 participants with autism enrolled in an OT clinical trial. We identified genetic association with plasma OT, several of which reside in known autism risk genes. We also show statistically significant association of plasma OT levels with gene expression and epigenetic across several gene pathways. These findings broaden our understanding of the factors that influence OT levels in the blood for future studies to decode the complex presentation of autism and its interaction with OT and OT-based treatment.

The estimated prevalence of autism spectrum disorder (ASD) is consistently higher in males than females. Gender differences in ASD have long been debated and are influenced by the historical period and source of the sample. The current study reports gender differences in core symptoms, associated features, and treatment response in 682 youth (585 males, 97 females) with ASD. The sample included participants (mean = 7.4 years; range 3–17 years) from six federally-funded, multisite, randomized clinical trials. These trials collected the same measures of social disability, repetitive behavior, adaptive skills, disruptive behavior, and anxiety pretreatment and used the Improvement scale of the Clinical Global Impression at study endpoint. Exploratory analyses yielded no differences between males and females across numerous pre-treatment measures. The rate of positive response was 49.7% for males and 53.6% for females (Chi square = 0.50; p = 0.48). In this sample of convenience, youth with ASD clinical characteristics and response to treatment showed no significant gender differences.

Objective: Anxiety disorders are among the most common co-occurring conditions in autism spectrum disorder (ASD). Despite their prevalence and impact, there are no randomized controlled trials (RCTs) aimed at evaluating the efficacy of selective serotonin reuptake inhibitors (SSRIs) for anxiolysis in this population, who may have a different biological basis for anxiety. Methods: Secondary analyses of the STAART double-blind, placebo-controlled RCT of citalopram in children with ASD examined whether citalopram reduced anxiety measured on the parent-reported Child and Adolescent Symptom Inventory-4 (CASI-4) as the primary outcome. An intention-To-Treat analysis involving all 149 participants used multiple imputations for missing data and included baseline stratification factors of age group and site, among others. We prespecified as clinically significant a 33% reduction in anxiety in citalopram versus placebo, coinciding with 80% power. We tested whether communicative ability on the Vineland Communication score moderated treatment effect and explored whether initial anxiety was associated with greater adverse events, which could impact on dose titration and achieving optimal dose. Results: Both groups showed substantial reduction in anxiety. Citalopram was associated with a nonsignificant 16.5% greater reduction (observed coefficient =-0.181, bootstrap standard error = 0.126, p = 0.151, confidence interval =-0.428 to 0.066). Anxiety reports were significantly lower in children with reduced communicative ability, but communicative ability did not moderate the treatment effect (interaction p = 0.294). Initial anxiety levels were not associated with increased adverse effects (interaction ps 0.162-0.954). Conclusion: Citalopram did not statistically significantly improve anxiety in children with ASD. Clinicians should be cautious in their use of SSRIs for this indication. There remains a need for well-powered clinical trials testing the efficacy of SSRIs among autistic children with anxiety disorders.

BACKGROUND: Experimental studies and small clinical trials have suggested that treatment with intranasal oxytocin may reduce social impairment in persons with autism spectrum disorder. Oxytocin has been administered in clinical practice to many children with autism spectrum disorder. METHODS: We conducted a 24-week, placebo-controlled phase 2 trial of intranasal oxytocin therapy in children and adolescents 3 to 17 years of age with autism spectrum disorder. Participants were randomly assigned in a 1:1 ratio, with stratification according to age and verbal fluency, to receive oxytocin or placebo, administered intranasally, with a total target dose of 48 international units daily. The primary outcome was the least-squares mean change from baseline on the Aberrant Behavior Checklist modified Social Withdrawal subscale (ABC-mSW), which includes 13 items (scores range from 0 to 39, with higher scores indicating less social interaction). Secondary outcomes included two additional measures of social function and an abbreviated measure of IQ. RESULTS: Of the 355 children and adolescents who underwent screening, 290 were enrolled. A total of 146 participants were assigned to the oxytocin group and 144 to the placebo group; 139 and 138 participants, respectively, completed both the baseline and at least one postbaseline ABC-mSW assessments and were included in the modified intention-to-treat analyses. The least-squares mean change from baseline in the ABC-mSW score (primary outcome) was −3.7 in the oxytocin group and −3.5 in the placebo group (least-squares mean difference, −0.2; 95% confidence interval, −1.5 to 1.0; P = 0.61). Secondary outcomes generally did not differ between the trial groups. The incidence and severity of adverse events were similar in the two groups. CONCLUSIONS: This placebo-controlled trial of intranasal oxytocin therapy in children and adolescents with autism spectrum disorder showed no significant between-group differences in the least-squares mean change from baseline on measures of social or cognitive functioning over a period of 24 weeks. (Funded by the National Institute of Child Health and Human Development; SOARS-B ClinicalTrials.gov number, NCT01944046.)

Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) that reduces obsessive–compulsive symptoms. There is limited evidence supporting its efficacy for repetitive behaviors (RRBs) in autistic spectrum disorder (ASD). We conducted a randomized controlled trial (RCT) of fluoxetine in 158 individuals with ASD (5–17 years). Following 14 treatment weeks (mean dose 11.8 mg/day), no significant differences were noted on the Children’s Yale-Brown Obsessive Compulsive Scale; the proportion of responders was similar (fluoxetine: 36%; placebo: 41%). There were similar rates of AEs (e.g., insomnia, diarrhea, vomiting); high rates of activation were reported in both groups (fluoxetine: 42%; placebo: 45%). Overly cautious dosing/duration may have prevented attainment of a therapeutic level. Results are consistent with other SSRI RCTs treating RRBs in ASD. Trial Registration: clinicaltrials.gov Identifier: NCT00515320.

When COVID-19 disrupted autism spectrum disorder research globally, many clinical trials of behavioral interventions pivoted to telehealth. Telehealth has the potential to increase geographic reach and improve racial/ethnic diversity in research. This matters because most autism spectrum disorder intervention studies have primarily included White, upper-middle-income families from North America and Europe. Participant homogeneity limits our ability to identify what types of intervention works in which context for which populations. Importantly, telehealth needs to “fit” the local context, and in particular, include strategies that factor in the “digital divide.” This short report details contextual considerations and pre-implementation pragmatic adaptations in two autism spectrum disorder clinical trials that include Early Start Denver Model–informed caregiver coaching in the United States and South Africa. By comparing and contrasting how implementation context informed the telehealth pivot in these two clinical trials in different hemispheres, we highlight equity considerations for adaption. The pandemic is an opportunity to understand how remote intervention can “fit” diverse contexts, while providing valid scientific results. It is however important that adaptations be documented and feasibility of the adapted approach be tracked. COVID-19-related telehealth adaptations of behavioral interventions could facilitate the development of new strategies with wider global impact. Lay abstract COVID-19 caused many autism spectrum disorder caregiver-coaching studies to move to telehealth. Telehealth can increase the diversity of people who take part in research. This matters because most autism spectrum disorder studies have included people who have resources, are White, and live in North America and Europe. When study participants are similar, it is hard to understand which interventions can help different types of people who live in different parts of the world. While telehealth may allow more people to take part in research, it needs to “fit” the local context and consider the “digital divide” because many people around the world have no access to computers and the Internet. This short report describes changes to two research studies that include caregiver coaching based on the Early Start Denver Model in the United States and South Africa. We describe how the local context, including technology and Internet access, guided the telehealth approach. By doing so, we highlight ways to make telehealth available to more people around the world. The pandemic can help us understand how telehealth can “fit” diverse places and support high-quality research. It is important that study changes are tracked and we assess how well the changes work. COVID-19 telehealth changes to caregiver coaching can result in new ways to reach more people around the world.

There are no approved medications for the core symptoms of autism spectrum disorder (ASD), socialization and communication difficulties.To evaluate the efficacy and safety of balovaptan, an oral selective vasopressin 1a receptor antagonist, compared with placebo in children and adolescents with ASD.The aV1ation study was a randomized, double-blind, 24-week, parallel-group, placebo-controlled phase 2 trial. Between November 22, 2016, and September 3, 2019, individuals were screened and randomly assigned to treatment groups. The primary efficacy analysis population comprised participants taking age-adjusted balovaptan equivalent to a 10-mg adult dose and participants from the concurrently randomized placebo group. This multicenter trial took place across 41 sites in the US. Participants were aged 5 to 17 years with diagnosed ASD and an IQ of 70 or greater. Data were analyzed from April 8 to November 16, 2020.Participants were randomly assigned to daily 4-mg or 10-mg adult-equivalent balovaptan or placebo, until the 4-mg group was discontinued.The primary end point was change from baseline on the Vineland-II two-domain composite (2DC; socialization and communication domains) score at week 24.Between November 2016 and September 2019, a total of 599 individuals were screened and 339 participants were randomly assigned to receive 4-mg balovaptan adult-equivalent dose (91 [26.8%]), 10-mg balovaptan adult-equivalent dose (126 [37.2%]), or placebo (122 [36.0%]). Primary analysis included 86 participants assigned to receive 10-mg balovaptan adult-equivalent dose and 81 assigned to receive placebo (mean [SD] age, 12.1 [3.4] years; 139 male participants [83.2%]). No statistically significant differences were observed between the balovaptan and placebo groups in change from baseline on the Vineland-II 2DC score at week 24 (difference in adjusted least-squares mean, -0.16; 90% CI, -2.56 to 2.23; P = .91). No improvements for balovaptan vs placebo were observed at week 24 for any secondary end points. Balovaptan was well tolerated with no emerging safety concerns. Similar proportions of participants reported adverse events (balovaptan, 66 of 86 [76.7%] vs placebo, 61 of 81 [75.3%]) and serious adverse events (balovaptan, 1 of 86 [1.2%] vs placebo, 4 of 81 [4.9%]).In this randomized clinical trial, balovaptan did not demonstrate efficacy in improvement of socialization and communication in this population with pediatric ASD. Balovaptan was well tolerated in children 5 years or older. Further development of robust, sensitive, and objective outcome measures may help to improve future studies in the assessment of therapies targeting communication and socialization in pediatric ASD.ClinicalTrials.gov Identifier: NCT02901431.

Parents of children with autism spectrum disorder (ASD) face higher levels of caregiver strain compared to parents of children with other disabilities. This study examined child clinical features that predict high levels of caregiver strain for 374 parents of children with ASD. Caregiver strain was measured using the Caregiver Strain Questionnaire (CGSQ) objective, subjective internalized, and subjective externalized subscales. Confirmatory factor analysis indicated an acceptable fit for the original CGSQ three-factor solution. The strongest child predictors across CGSQ subscales were: disruptive behavior for objective strain, autism severity and disruptive behavior for subjective internalized strain, and oppositional behavior and hyperactivity for subjective externalized strain. Individualized interventions that attend to specific elements of parental strain may reduce strain and improve family wellbeing.

Objective To describe the rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B). Method This phase 2 clinical trial was designed to evaluate the use of intranasal oxytocin treatment to improve social difficulties in individuals with autism spectrum disorder (ASD). In total, 290 participants ages 3 to 17 years with a DSM-5 diagnosis of ASD were enrolled to receive 24 weeks of treatment with either oxytocin or a matched placebo at one of seven collaborating sites. Participants were subsequently treated with open-label oxytocin for 24 additional weeks. Post-treatment assessments were done approximately 4 weeks after treatment discontinuation. Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, and week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response. Results This report describes the rationale, design, and methods of the SOARS-B clinical trial. Conclusions There is a tremendous unmet need for safe and effective pharmacological treatment options that target the core symptoms of ASD. Several studies support the hypothesis that intranasal oxytocin could improve social orienting and the salience of social rewards in ASD, thereby enhancing reciprocal social behaviors. However, due to conflicting results from a number of pilot studies on the prosocial effects of exogenous oxytocin, this hypothesis remains controversial and inconclusive. SOARS-B is the best powered study to date to address this hypothesis and promises to improve our understanding of the safety and efficacy of intranasal oxytocin in the treatment of social deficits in children with ASD.

ObjectiveTo review pharmacologic and nonpharmacologic strategies for treating sleep disturbances in children and adolescents with autism spectrum disorder (ASD) and to develop recommendations for addressing sleep disturbance in this population.MethodsThe guideline panel followed the American Academy of Neurology 2011 guideline development process, as amended. The systematic review included studies through December 2017. Recommendations were based on evidence, related evidence, principles of care, and inferences.Major recommendations (Level B)For children and adolescents with ASD and sleep disturbance, clinicians should assess for medications and coexisting conditions that could contribute to the sleep disturbance and should address identified issues. Clinicians should counsel parents regarding strategies for improved sleep habits with behavioral strategies as a first-line treatment approach for sleep disturbance either alone or in combination with pharmacologic or nutraceutical approaches. Clinicians should offer melatonin if behavioral strategies have not been helpful and contributing coexisting conditions and use of concomitant medications have been addressed, starting with a low dose. Clinicians should recommend using pharmaceutical-grade melatonin if available. Clinicians should counsel children, adolescents, and parents regarding potential adverse effects of melatonin use and the lack of long-term safety data. Clinicians should counsel that there is currently no evidence to support the routine use of weighted blankets or specialized mattress technology for improving disrupted sleep. If asked about weighted blankets, clinicians should counsel that the trial reported no serious adverse events with blanket use and that blankets could be a reasonable nonpharmacologic approach for some individuals.

The presence of attention deficit/hyperactivity disorder (ADHD) symptoms in children with autism spectrum disorder (ASD) is associated with worse cognitive control. Children with ASD and ADHD often respond poorly to medications, thus we need alternative treatments. We examined the feasibility, acceptability, and preliminary efficacy of Project Evo-a digital treatment. Nineteen children with ASD and co-occurring ADHD symptoms completed this app-based treatment that targets multi-tasking through gameplay versus a comparison educational treatment. Children had a high engagement with both treatments, and parents and children reported high acceptability. Within-group analyses suggest the multi-tasking but not the educational treatment may improve cognitive control. This multi-tasking treatment is feasible, acceptable, and possibly efficacious for cognitive control impairments in children with ASD and ADHD.

Pediatric psychotropic prescription rates are rising, emphasizing the need for careful monitoring of drug safety in this population. Currently, no standardized assessments are used in clinical trials for adverse event (AE) elicitation focused on long-term drug treatment in pediatric patients. Despite a lack of standardized AE elicitation methods in psychiatric clinical trials, it is clear that psychiatric medications have developmentally dependent AEs that differ from those observed in adults. In this review, we discuss the use of general inquiry elicitation, drug-specific checklists, and systematic elicitation scales for AE reporting in pediatric psychopharmacology trials. The checklists evaluated include the Barkley Side Effect Rating Scales (SERS), the Pittsburg side effect rating scale, and the Systematic Monitoring of Adverse events Related to TreatmentS (SMARTS) checklist. The systematic assessment scales discussed include the Systematic Assessment for Treatment of Emergent Events (SAFTEE) and the Safety Monitoring Uniform Report Form (SMURF). We review the advantages and disadvantages of each method and discuss the need for optimal assessment of AEs. AE instruments that are created and utilized for pediatric psychiatric trials must begin to incorporate symptoms that are relevant to this population and account for the nature of the disorders to better characterize treatment-emergent AEs and monitor long-term safety.

Antipsychotics are used for many psychiatric conditions in youth. Although developmentally inappropriate weight gain and metabolic abnormalities, which are risk factors for premature cardiovascular mortality, are especially frequent in youth, optimal strategies to reduce pediatric antipsychotic-induced overweight/obesity are unclear. The Improving Metabolic Parameters in Antipsychotic Child Treatment (IMPACT) was a randomized, parallel group, 24-week clinical trial which enrolled overweight/obese, psychiatrically stable youth, aged 8-19 years, with a DSM-IV diagnosis of severe mental illness (schizophrenia spectrum disorder, bipolar spectrum disorder or psychotic depression), at four US universities. All of them had developed substantial weight gain following treatment with a second-generation antipsychotic. The centralized, computer-based randomization system assigned participants to unmasked treatment groups: metformin (MET); antipsychotic switch (aripiprazole or, if already exposed to that drug, perphenazine or molindone; SWITCH); or continued baseline antipsychotic (CONTROL). All participants received healthy lifestyle education. The primary outcome was body mass index (BMI) z-score change from baseline, analyzed using estimated least squares means. Altogether, 127 participants were randomized: 49 to MET, 31 to SWITCH, and 47 to CONTROL. BMI z-score decreased significantly with MET (week 24: -0.09±0.03, p=0.002) and SWITCH (week 24: -0.11±0.04, p=0.003), while it increased non-significantly with CONTROL (week 24: +0.04±0.03). On 3-way comparison, BMI z-score changes differed significantly (p=0.001). MET and SWITCH were each superior to CONTROL (p=0.002), with effect sizes of 0.68 and 0.81 respectively, while MET and SWITCH did not differ. More gastrointestinal problems occurred in MET than in SWITCH or CONTROL. The data safety monitoring board closed the perphenazine-SWITCH arm because 35.2% of subjects discontinued treatment due to psychiatric worsening. These data suggest that pediatric antipsychotic-related overweight/obesity can be reduced by adding metformin or switching to a lower risk antipsychotic. Healthy lifestyle education is not sufficient to prevent ongoing BMI z-score increase.

Clinical research in neurodevelopmental disorders remains reliant upon clinician and caregiver measures. Limitations of these approaches indicate a need for objective, quantitative, and reliable biomarkers to advance clinical research. Extant research suggests the potential utility of multiple candidate biomarkers; however, effective application of these markers in trials requires additional understanding of replicability, individual differences, and intra-individual stability over time. The Autism Biomarkers Consortium for Clinical Trials (ABC-CT) is a multi-site study designed to investigate a battery of electrophysiological (EEG) and eye-tracking (ET) indices as candidate biomarkers for autism spectrum disorder (ASD). The study complements published biomarker research through: inclusion of large, deeply phenotyped cohorts of children with autism spectrum disorder (ASD) and typical development; a longitudinal design; a focus on well-evidenced candidate biomarkers harmonized with an independent sample; high levels of clinical, regulatory, technical, and statistical rigor; adoption of a governance structure incorporating diverse expertise in the ASD biomarker discovery and qualification process; prioritization of open science, including creation of a repository containing biomarker, clinical, and genetic data; and use of economical and scalable technologies that are applicable in developmental populations and those with special needs. The ABC-CT approach has yielded encouraging results, with one measure accepted into the FDA’s Biomarker Qualification Program to date. Through these advances, the ABC-CT and other biomarker studies in progress hold promise to deliver novel tools to improve clinical trials research in ASD.

Autism spectrum disorders (ASDs) and schizophrenia spectrum disorders co-occur at elevated rates. Although these conditions are diagnostically distinct, they share multiple clinical features and genetic risk factors. This article describes the epidemiologic features and clinical manifestations of psychosis in individuals with ASDs, while also discussing shared genetic risk factors and affected brain regions. Components of a diagnostic assessment, including a thorough developmental, behavioral, medical, and psychiatric history, will be reviewed. The authors highlight the manifestations of catatonia in this population and note the shared features between catatonia and ASDs. Finally, treatment approaches and areas for future study are suggested.

Objectives 1) To describe activation skills of African American parents on behalf of their children with mental health needs. 2) To assess the association between parent activation skills and child mental health service use. Methods Data obtained in 2010 and 2011 from African American parents in North Carolina raising a child with mental health needs (n = 325) were used to identify child mental health service use from a medical provider, counselor, therapist, or any of the above or if the child had ever been hospitalized. Logistic regression was used to model the association between parent activation and child mental health service use controlling for predisposing, enabling, and need characteristics of the family and child. Results Mean parent activation was 65.5%. Over two-thirds (68%) of children had seen a medical provider, 45% had seen a therapist, and 36% had seen a counselor in the past year. A quarter (25%) had been hospitalized. A 10-unit increase in parent activation was associated with a 31% higher odds that a child had seen any outpatient provider for their mental health needs (odds ratio = 1.31, confidence interval = 1.03-1.67, p = 0.03). The association varied by type of provider. Parent activation was not associated with seeing a counselor or a therapist or with being hospitalized. Conclusion African American families with activation skills are engaged and initiate child mental health service use. Findings provide a rationale for investing in the development and implementation of interventions that teach parent activation skills and facilitate their use by practices in order to help reduce disparities in child mental health service use.

We sought to assess the association between age and the prevalence of obesity among children with and without autism spectrum disorder (ASD) in the 2011-2012 National Survey of Children's Health.Analyses were restricted to 43,777 children, ages 10-17, with valid measures of parent-reported weight, height, and ASD status. Exploratory analyses describe the impact of sex, race/ethnicity, and household income on the relationship between age and obesity in ASD.Although the overall prevalence of obesity among children with ASD was significantly (p 0.001) higher than among children without ASD (23.1% vs. 14.1%, 95% confidence interval for difference 3.6 to 14.4), child age significantly (p = 0.035) modified this difference. In a multivariable logistic regression analysis, adjusted for sex, race/ethnicity, and household income, the odds of obesity among children with ASD compared with children without ASD increased monotonically from ages 10 to 17 years. This pattern arose due to a consistently high prevalence of obesity among children with ASD and a decline in prevalence with advancing age among children without ASD. These findings were replicated using a propensity score analysis. Exploratory analyses suggested that the age-related change in obesity disparity between children with and without ASD may be further modified by sex, race/ethnicity, and household income.The patterns of prevalence observed with increasing age among children with and without ASD were unexpected. A better understanding of the etiological and maintenance factors for obesity in youth with ASD is needed to develop interventions tailored to the specific needs of these children.

Objective To evaluate whether umbilical cord blood (CB) infusion is safe and associated with improved social and communication abilities in children with autism spectrum disorder (ASD). Study design This prospective, randomized, placebo-controlled, double-blind study included 180 children with ASD, aged 2-7 years, who received a single intravenous autologous (n = 56) or allogeneic (n = 63) CB infusion vs placebo (n = 61) and were evaluated at 6 months postinfusion. Results CB infusion was safe and well tolerated. Analysis of the entire sample showed no evidence that CB was associated with improvements in the primary outcome, social communication (Vineland Adaptive Behavior Scales-3 [VABS-3] Socialization Domain), or the secondary outcomes, autism symptoms (Pervasive Developmental Disorder Behavior Inventory) and vocabulary (Expressive One-Word Picture Vocabulary Test). There was also no overall evidence of differential effects by type of CB infused. In a subanalysis of children without intellectual disability (ID), allogeneic, but not autologous, CB was associated with improvement in a larger percentage of children on the clinician-rated Clinical Global Impression-Improvement scale, but the OR for improvement was not significant. Children without ID treated with CB showed significant improvements in communication skills (VABS-3 Communication Domain), and exploratory measures including attention to toys and sustained attention (eye-tracking) and increased alpha and beta electroencephalographic power. Conclusions Overall, a single infusion of CB was not associated with improved socialization skills or reduced autism symptoms. More research is warranted to determine whether CB infusion is an effective treatment for some children with ASD.

The presence of attention deficit/hyperactivity disorder (ADHD) symptoms in children with autism spectrum disorder (ASD) is associated with worse cognitive control. Children with ASD and ADHD often respond poorly to medications, thus we need alternative treatments. We examined the feasibility, acceptability, and preliminary efficacy of Project Evo-a digital treatment. Nineteen children with ASD and co-occurring ADHD symptoms completed this app-based treatment that targets multi-tasking through gameplay versus a comparison educational treatment. Children had a high engagement with both treatments, and parents and children reported high acceptability. Within-group analyses suggest the multi-tasking but not the educational treatment may improve cognitive control. This multi-tasking treatment is feasible, acceptable, and possibly efficacious for cognitive control impairments in children with ASD and ADHD.

Background The prevalence of obesity in children with autism spectrum disorder (ASD) exceeds that of the general population, but the level of parental concern about obesity in these children is unexplored. Objective We estimate the prevalence of obesity in children 10–17 years in the redesigned National Survey of Children's Health (NSCH) 2016, and compare parental concern about obesity between parents of children with and without ASD. Methods The nationally representative NSCH 2016 oversampled parents of children with parent-report of special health care needs, including ASD. Parents opted to complete the survey via the web or surface mail. Following report of their child's height and weight, parents were asked “Are you concerned about their weight?” Response options included: “Yes, it's too high,” “Yes, it's too low,” or “No, I am not concerned.” Obesity (>95th percentile BMI) was defined using the 2000 CDC growth reference. We used logistic regression to compare odds of obesity, and odds of parental concern, between children with and without ASD. Results In 24,251 children, ASD (n = 699) increased obesity risk after adjusting for age, sex, and race/ethnicity (OR = 1.54, 95%CI: 1.11, 2.14). ASD medication did not significantly affect obesity. ASD increased obesity concern (OR = 2.17, 95%CI: 1.53, 4.81) among parents with obese children. Parents of boys with obesity and ASD had less obesity concern if he was taking medication for ASD (OR = 0.258, 95%CI: 0.09, 0.78). Conclusion While the prevalence of obesity is elevated in children with ASD, parental obesity concern is high, suggesting opportunities for the development of parent-focused obesity prevention and treatment interventions for this population.

Background Intranasal oxytocin (OT) has been shown to improve social communication functioning of individuals with autism spectrum disorder (ASD) and, thus, has received considerable interest as a potential ASD therapeutic agent. Although preclinical research indicates that OT modulates the functional output of the mesocorticolimbic dopamine system that processes rewards, no clinical brain imaging study to date has examined the effects of OT on this system using a reward processing paradigm. To address this, we used an incentive delay task to examine the effects of a single dose of intranasal OT, versus placebo (PLC), on neural responses to social and nonsocial rewards in children with ASD. Methods In this placebo-controlled double-blind study, 28 children and adolescents with ASD (age: M = 13.43 years, SD = 2.36) completed two fMRI scans, one after intranasal OT administration and one after PLC administration. During both scanning sessions, participants completed social and nonsocial incentive delay tasks. Task-based neural activation and connectivity were examined to assess the impact of OT relative to PLC on mesocorticolimbic brain responses to social and nonsocial reward anticipation and outcomes. Results Central analyses compared the OT and PLC conditions. During nonsocial reward anticipation, there was greater activation in the right nucleus accumbens (NAcc), left anterior cingulate cortex (ACC), bilateral orbital frontal cortex (OFC), left superior frontal cortex, and right frontal pole (FP) during the OT condition relative to PLC. Alternatively, during social reward anticipation and outcomes, there were no significant increases in brain activation during the OT condition relative to PLC. A Treatment Group × Reward Condition interaction revealed relatively greater activation in the right NAcc, right caudate nucleus, left ACC, and right OFC during nonsocial relative to social reward anticipation during the OT condition relative to PLC. Additionally, these analyses revealed greater activation during nonsocial reward outcomes during the OT condition relative to PLC in the right OFC and left FP. Finally, functional connectivity analyses generally revealed changes in frontostriatal connections during the OT condition relative to PLC in response to nonsocial, but not social, rewards. Conclusions The effects of intranasal OT administration on mesocorticolimbic brain systems that process rewards in ASD were observable primarily during the processing of nonsocial incentive salience stimuli. These findings have implications for understanding the effects of OT on neural systems that process rewards, as well as for experimental trials of novel ASD treatments developed to ameliorate social communication impairments in ASD. Electronic supplementary material The online version of this article (10.1186/s11689-018-9228-y) contains supplementary material, which is available to authorized users.

Second-generation antipsychotic (SGA) medications are prescribed to children and adolescents for FDA-indicated treatment of irritability in autism, bipolar spectrum disorders, and psychotic symptoms as well as for off-label treatment of severe aggression and mood dysregulation. Unfortunately pediatric patients are particularly vulnerable to metabolic side effects of these medications compared to adults. This chapter reviews pediatric data on SGA-induced weight gain, dyslipidemia, and hyperglycemia/new-onset diabetes. Possible underlying mechanisms of SGA metabolic side effects are discussed, as well as pharmacologic and non-pharmacologic strategies to manage these health issues. Future research is needed to better identify predictors of pediatric metabolic side effects and novel prevention strategies for SGA-induced obesity.

The prevention of obesity in children with DD is a pressing public health issue, with implications for health status, independent living, and quality of life. Substantial evidence suggests that children with developmental disabilities (DD), including those with intellectual disabilities (ID) and autism spectrum disorder (ASD), have a prevalence of obesity at least as high if not higher than their typically developing peers. The paper reviews what is known about the classic and unique risk factors for childhood obesity in these groups of children, including dietary, physical activity, sedentary behavior, and family factors, as well as medication use. We use evidence from the literature to make the case that primary prevention at the individual/family, school and community levels will require tailoring of strategies and adapting existing intervention approaches.

Recognizing positive psychotic symptoms and their diagnostic context in youth is challenging. A large minority say they "hear things others do not hear," though they seldom present with complaints of hallucinations or delusions. Few have schizophrenia spectrum disorder, but many have other psychiatric disorders. Frequently, they have psychotic symptoms for an extended period before diagnosis. Clinicians should understand psychotic symptoms and their differential diagnoses. This article reviews the epidemiology, associated diagnoses, and prognosis of hallucinations and delusions in youth. Strategies for optimizing the clinical diagnostic interview, appropriate laboratory tests, indications for psychological testing, and rating scales are reviewed.

This study examined the long-term effectiveness of lithium for the treatment of pediatric bipolar disorder within the context of combination mood stabilizer therapy for refractory mania and pharmacological treatment of comorbid psychiatric conditions.Outpatients, ages 7-17 years, meeting American Psychiatric Association, diagnostic and statistical manual of mental disorders, 4th ed. (DSM-IV) diagnostic criteria for bipolar disorder I (BP-I) (manic or mixed) who demonstrated at least a partial response to 8 weeks of open-label treatment with lithium (phase I) were eligible to receive open-label lithium for an additional 16 weeks (phase II). Up to two adjunctive medications could be prescribed to patients experiencing residual symptoms of mania or comorbid psychiatric conditions, following a standardized algorithm.Forty-one patients received continued open-label long-term treatment with lithium for a mean of 14.9 (3.0) weeks during phase II. The mean weight-adjusted total daily dose at end of phase II was 27.8 (6.7) mg/kg/day, with an average lithium concentration of 1.0 (0.3) mEq/L. Twenty-five of the 41 patients (60.9%) were prescribed adjunctive psychotropic medications for residual symptoms. The most frequent indications for adjunctive medications were refractory mania (n=13; 31.7%) and attention-deficit/hyperactivity disorder (ADHD) (n=15; 36.6%). At the end of this phase 28 (68.3%) patients met a priori criteria for response (≥50% reduction from phase I baseline in young mania rating scale [YMRS] summary score and a clinical global impressions-improvement [CGI-I] score of 1 or 2), with 22 (53.7%) considered to be in remission (YMRS summary score≤12 and CGI-severity score of 1 or 2). These data suggest that patients who initially responded to lithium maintained mood stabilization during continuation treatment, but partial responders did not experience further improvement during Phase II, despite the opportunity to receive adjunctive medications. The most commonly reported (≥20%) adverse events associated with lithium treatment were vomiting, headache, abdominal pain, and tremor.Lithium may be a safe and effective longer-term treatment for patients with pediatric bipolar disorder who respond to acute treatment with lithium. Partial responders to acute lithium did not appear to experience substantial symptom improvement during the continuation phase, despite the possibility that adjunctive medications could be prescribed.

We examined rural-urban differences in emergency department visits, and child and clinical characteristics associated with visits for U.S. children aged 3-17 years with autism spectrum disorder (ASD). Rural children with ASD were twice more likely to have emergency department visits in urban hospitals than rural children without ASD. The children with ASD in rural areas were economically disadvantaged and concentrated in the South and Midwest regions. Rural children diagnosed with ASD and multiple comorbidities during emergency department visits were 1.6 times as that of urban children. Rural children with ASD, particularly those with multiple comorbidities, require more emergency department services when compared with urban children with ASD.

Functional magnetic resonance imaging (fMRI) has helped to elucidate the neurobiological bases of psychiatric and neurodevelopmental disorders by localizing etiologically-relevant aberrations in brain function. Functional MRI also has shown great promise to help understand potential mechanisms of action of effective treatments for a range of psychiatric and neurodevelopmental disorders, including mood and anxiety disorders, schizophrenia, and autism. However, the use of fMRI to probe intervention effects in psychiatry is associated with unique methodological considerations, including the psychometric properties of repeated fMRI scans, how to assess potential relations between the effects of an intervention on symptoms and on specific brain activation patterns, and how to best make causal inferences about intervention effects on brain function. Additionally, the study of treatment effects in neurodevelopmental disorders presents additional unique challenges related to brain maturation, analysis methods, and the potential for motion artifacts. We review these methodological considerations and provide recommendations for best practices for each of these topics.

The aim of our feasibility study was to examine the acceptability and utility of "Dance Dance Revolution" (DDR) (Konami of America, Redwood City, CA)) to increase physical fitness in 8-11-year-old black and Hispanic youth.Twenty-eight 4(th) and 5(th) grade children attending an afterschool program participated. Outcomes included physical activity, physical fitness, use of home DDR, survey of safety and acceptability, anthropometrics, and fasting metabolic profile measured at baseline, 12 weeks, and 30 weeks.At 12 weeks, physical fitness (maximum O2 uptake [VO2max]) increased by 4.9±9.9 percent and was sustained through 30 weeks, when the VO2max was 105.0±9.9 percent (range, 93.0-133.9 percent) of baseline values. Absolute VO2max increased by 2.97±4.99 mL/kg/minute (95% confidence interval 0.75-5.19, P=0.013). Participants maintained an average of 1.12 hours/day of increased movement to music. Trends suggested increased total moderate-vigorous physical activity, decreased light activity, and a modest increase in sedentary screen time. There were no significant changes in body mass index, fasting lipids, or glucose. Participants and parents approved of the activity.DDR appears feasible and acceptable to minority youth. DDR may increase moderate-vigorous physical activity and improve physical fitness in at-risk populations.

The primary goal of this exploratory study was to obtain data that could lead to evidence-based dosing strategies for lithium in children and adolescents suffering from bipolar I disorder.Outpatients aged 7-17 years meeting Diagnostic and Statistical Manual of Mental Disorders, 4th edition, diagnostic criteria for bipolar I disorder (manic or mixed) were eligible for 8 weeks of open label treatment with lithium in one of three dosing arms. In Arm I, participants began treatment at a dose of 300 mg of lithium twice daily. The starting dose of lithium in Arms II and III was 300 mg thrice daily. Patients in Arms I and II could have their dose increased by 300 mg/day, depending on clinical response, at weekly visits. Patients in Arm III also had mid-week telephone interviews after which they could also have their dose of lithium increased by 300 mg per day. Youths weighing30 kg were automatically assigned to Arm I, whereas youths weighing ≥30 kg were randomly assigned to Arm I, II, or III. Randomization was balanced by age (7-11 years, 12-17 years) and sex in approximately equal numbers. A priori response criteria were defined as a Clinical Global Impressions-Improvement scale score of ≤ 2 and a 50% decrease from baseline on the Young Mania Rating Scale.Of the 61 youths [32 males (52.5%)] who received open-label lithium, 60 youths completed at least 1 week of treatment and returned for a postbaseline assessment. Most patients had a ≥ 50% improvement in Young Mania Rating Scale score, and more than half of the patients (58%) achieved response. Overall, lithium was well tolerated. All three treatment arms had similar effectiveness, side effect profiles, and tolerability of lithium.On the basis of these results, a dosing strategy in which pediatric patients begin lithium at a dose of 300 mg thrice daily (with an additional 300 mg increase during the first week), followed by 300 mg weekly increases until a priori stopping criteria are met, will be used in an upcoming randomized, placebo-controlled trial.

Bipolar I disorder (BP-I) in children and adolescents is associated with substantive psychosocial dysfunction and human suffering [1, 2]. Safe and effective treatments are needed to reduce symptomatology and improve quality of life for the vulnerable youngsters and families impacted by this illness. Lithium is a benchmark treatment for adults suffering from bipolar illness [3], with evidence of benefit dating back almost 60 years [4]. However, there has been relatively little research regarding the use of lithium in the treatment of youths suffering from mania [5]. Given this paucity of information, a Written Request (WR) was issued by the Food and Drug Administration (FDA) under the auspices of the Best Pharmaceuticals for Children Act (BPCA) (FDA 2002) for the study of this agent in youths. In response, a contract was awarded to rigorously study lithium in children and adolescents with mania. A key step in developing evidence-based dosing paradigms for any compound is the characterization of the drug s pharmacokinetics (PK) [6]. Therefore, two of the goals of this contract were to characterize the pharmacokinetics of lithium and to develop evidence-based dosing for lithium in children and adolescents [7]. Although many studies have examined the PK of lithium in adults [8a??10], relatively little is known about the PK of lithium in pediatric patients. Vitiello et al. [11] described lithium PK in nine children (aged 9a??12 years) with a DSM-III-R primary diagnosis of conduct disorder or adjustment disorder. Subjects received one single 300 mg dose of lithium carbonate. The disposition of lithium in these children appeared to generally be similar to that seen in adults. However, their elimination half-life and greater total lithium clearance were shorter than reported in adult studies. The present study was performed in order to describe the first dose PK of lithium in children and adolescents. In addition to characterizing the disposition of lithium in children and adolescents with BP-I, we also explored whether patient-specific characteristics (e.g. age, gender and weight) influence the PK of lithium in this patient population.

Objective We examined the neuropsychological functioning of youth enrolled in the NIMH funded trial, Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS). We compared the baseline neuropsychological functioning of youth with schizophrenia (SZ, n=79) to those with schizoaffective disorder (SA, n=40), and examined the relationship of different variables of illness severity and adaptive behavior to neuropsychological functioning. Method Participants ranged in age from 8 to 19 years. Diagnostic status was confirmed via structured interview over multiple time points. Domains of neuropsychological functioning included fine-motor, attention, working memory, problem-solving efficiency, inhibitory control, and social cognition. Other variables included intelligence (IQ), academic achievement skills, adaptive behavior, and different measures of illness severity. Results The two groups did not differ on IQ or on any of the neuropsychological domains. The SZ group performed significantly lower in spelling. A high proportion of individuals in both groups reflected significant intellectual and academic achievement skill deficits. Significant correlations were found between the neurocognitive domains and both illness severity and adaptive behavior variables. Conclusions There were few differences between the SZ and SA groups on IQ, achievement, or neuropsychological functioning; however, both groups showed significantly high rates of deficits in IQ and basic academic skills. Correlations of the neurocognitive functions with illness severity and adaptive behavior were small to moderate in magnitude. These findings continue to implicate the importance of neurocognitive functioning as a key area of vulnerability in the study of youth with schizophrenia spectrum disorders.

OBJECTIVE: The objective of this study was to evaluate short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder who were manifesting behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these. METHODS: This 8-week, double-blind, randomized, placebo-controlled, parallel-group study was conducted of children and adolescents (aged 6–17 years) with autistic disorder. Patients were randomly assigned (1:1) to flexibly dosed aripiprazole (target dosage: 5, 10, or 15 mg/day) or placebo. Efficacy outcome measures included the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression–Improvement score (CGI-I). Safety and tolerability were also assessed. RESULTS: Ninety-eight patients were randomly assigned to receive placebo (n = 51) or aripiprazole (n = 47). Mean improvement in Aberrant Behavior Checklist irritability subscale score was significantly greater with aripiprazole than with placebo from week 1 through week 8. Aripiprazole demonstrated significantly greater global improvements than placebo, as assessed by the mean CGI-I score from week 1 through week 8; however, clinically significant residual symptoms may still persist for some patients. Discontinuation rates as a result of adverse events (AEs) were 10.6% for aripiprazole and 5.9% for placebo. Extrapyramidal symptom-related AE rates were 14.9% for aripiprazole and 8.0% for placebo. No serious AEs were reported. Mean weight gain was 2.0 kg on aripiprazole and 0.8 kg on placebo at week 8. CONCLUSIONS: Aripiprazole was efficacious in children and adolescents with irritability associated with autistic disorder and was generally safe and well tolerated.

Objective: Children and adolescents with schizophrenia share a similar pattern of phenomenological, genetic and cognitive abnormalities to adults with schizophrenia. However, an early-onset of schizophrenia (EOS) (prior to 18 years of age) is associated with a higher frequency of risk indicators associated with schizophrenia (e.g. developmental delays and familial spectrum disorders) and a worse long-term outcome. This overview examines recent research on the neurobiological alterations, possible causes, developmental trajectory and treatment of EOS and attempts to identify gaps in the field. Method: The authors provide a selective review of major findings from genetics, neuroimaging and treatment studies of pediatric schizophrenia that were presented at a workshop sponsored by the National Institute of Mental Health. These data are synthesized in conjunction with preclinical studies into a model of the pathophysiology of EOS. Results: EOS is associated with a high frequency of cytogenetic abnormalities (e.g. velocardiofacial syndrome, sex chromosome anomalies) and other rare denovo chromosomal aberrations. Brain imaging research in adolescents with EOS has revealed a progressive loss of cortical grey matter post-onset of psychosis and subtle abnormalities in white matter microstructure. Although EOS patients are more likely to be treatment-refractory than their adult counterparts, there are substantial data that this subgroup is particularly responsive to clozapine. Conclusions: Genetic or environmental factors operating during adolescence that reduce frontal capacity might contribute to an EOS in susceptible individuals. Additional longitudinal studies of adolescents with schizophrenia are needed to better understand the relationship between structural changes in fronto-limbic regions, stress responsivity, and cognitive and neurochemical development.

Atypical (second-generation) antipsychotics are considered standard treatment for children and adolescents with early-onset schizophrenia and schizoaffective disorder. However, the superiority of second-generation antipsychotics over first-generation antipsychotics has not been demonstrated. This study compared the efficacy and safety of two second-generation antipsychotics (olanzapine and risperidone) with a first-generation antipsychotic (molindone) in the treatment of early-onset schizophrenia and schizoaffective disorder.This double-blind multisite trial randomly assigned pediatric patients with early-onset schizophrenia and schizoaffective disorder to treatment with either olanzapine (2.5-20 mg/day), risperidone (0.5-6 mg/day), or molindone (10-140 mg/day, plus 1 mg/day of benztropine) for 8 weeks. The primary outcome was response to treatment, defined as a Clinical Global Impression (CGI) improvement score of 1 or 2 andor=20% reduction in Positive and Negative Syndrome Scale (PANSS) total score after 8 weeks of treatment.In total, 119 youth were randomly assigned to treatment. Of these subjects, 116 received at least one dose of treatment and thus were available for analysis. No significant differences were found among treatment groups in response rates (molindone: 50%; olanzapine: 34%; risperidone: 46%) or magnitude of symptom reduction. Olanzapine and risperidone were associated with significantly greater weight gain. Olanzapine showed the greatest risk of weight gain and significant increases in fasting cholesterol, low density lipoprotein, insulin, and liver transaminase levels. Molindone led to more self-reports of akathisia.Risperidone and olanzapine did not demonstrate superior efficacy over molindone for treating early-onset schizophrenia and schizoaffective disorder. Adverse effects were frequent but differed among medications. The results question the nearly exclusive use of second-generation antipsychotics to treat early-onset schizophrenia and schizoaffective disorder. The safety findings related to weight gain and metabolic problems raise important public health concerns, given the widespread use of second-generation antipsychotics in youth for nonpsychotic disorders.

Objective: We examined the feasibility of Dance Dance Revolution (DDR), a dance video game, in participants' homes, to increase physical activity (PA) and to decrease sedentary screen time (SST). Methods And Procedures: Sixty children (7.5 ± 0.5 years) were randomized in a 2:1 ratio to DDR or to wait-list control (10-week delay). DDR use was logged, PA was measured objectively by accelerometry. SST was self-reported at weeks 0 and 10. At week 28, after both groups had access to DDR, accelerometry and SST were repeated. Results: Mean use of DDR was 89 ± 82 (range 0–660min) min per week (mpw). The DDR group showed increased vigorous PA and a reduction in light PA; the control group showed no increase in moderate and/or vigorous PA (MVPA) although they also had a reduction in light PA. Differences between the groups were not observed. The DDR group also reported a decrease in SST of −1.2 ± 3.7 h per week (hpw) (P < 0.05), whereas the controls reported an increase of +3.0 ± 7.7 hpw (nonsignificant). The difference in SST between the groups was significant, with less SST in the DDR group. Between weeks 10 and 28, numeric reductions in SST were reported in both groups. In the DDR group, SST at week 28 (8.8 ± 6.0 hpw) was lower than baseline (10.5 ± 5.5 hpw; P < 0.03). Discussion: This pilot study suggests that DDR reduces SST and may facilitate slight increases in vigorous PA. Further study is needed to better characterize children and contexts in which DDR may promote a healthy lifestyle.