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Over the past 10 years, identification of Autism Spectrum Disorder (ASD) risk has dramatically increased due to the wide-spread implementation of screening programs; yet, there is limited understanding about parent perceptions and experiences during the time period when risk is identified, but prior to receiving a formal diagnosis—a period that can last months to years given the long wait-lists for formal ASD evaluations. The current study aimed to examine parent perceptions of family impact (i.e., the impact their child’s behaviors have on the family) between the time of risk-identification and formal diagnosis among 277 children identified as at-risk for ASD through screening positive in primary care. We aimed to compare family impact among those whose child met diagnostic criteria for ASD and those who did not. Parents of children who received a non-ASD diagnosis reported a higher baseline level of family impact (F[1, 274] = 5.82, p = .017); however, perceived difficult child behavior was a stronger predictor of family impact (t[6] = 13.11, p

Objective Families, pediatric providers, and service systems would benefit from expanded knowledge regarding (1) who is most likely to receive a recommended diagnostic evaluation after a positive primary care-administered autism screen and (2) of those who screen positive, who is most likely to be diagnosed with autism? Method Participants included 309 predominantly low-income, racial/ethnic minority parents and their child, aged 15 to 27 months, who screened positive on the Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F). Generalized estimating equations were used to fit models of predictors for each binary outcome: receiving a diagnostic evaluation and receiving an autism diagnosis on evaluation. Results Significant predictors of diagnostic evaluation receipt included the parent being older or non-Hispanic and the child having private insurance, lower child communication functioning, or receiving Early Intervention services. Significant predictors of an autism diagnosis on evaluation included male child, lower child communication functioning, screening directly in the parent's preferred language, White/non-Hispanic parent, and no parent history of mood disorder. Conclusion Children with younger parents, Hispanic ethnicity, relatively higher communication skills, public insurance, and no Early Intervention services were less likely to receive recommended diagnostic care. Reduced likelihood of autism diagnosis after a positive screen in non-White/non-Hispanic subgroups supports previous research indicating issues with M-CHAT-R/F positive predictive power for racial/ethnic minorities. The use of telephonic interpreters to administer screens, as opposed to directly screening in families' preferred languages, may lead to identification of fewer true autism cases. Thus, multilingual clinical staff capacity may improve positive predictive power of autism screening.

Parents of children with autism spectrum disorder (ASD) show increased levels of parenting stress, but only one study has examined this association before a diagnostic evaluation. We conducted a cross-sectional study of parenting stress in 317 low SES parents with children at-risk for ASD before a diagnostic evaluation. Multiple regression modeling evaluated the associations between parenting stress and parent and child factors. Parenting stress was negatively associated with social support and positively associated with active avoidance coping and parental worry. However, parenting stress was not associated with the child’s ASD symptom severity or adaptive functioning, except for self-direction. Findings suggest parenting stress among parents of children at risk of ASD should be assessed prior to diagnosis.

Children in low-income families are at risk for delayed diagnosis of autism spectrum disorder (ASD). The cascade-of-care model, which examines steps of care for quality and efficacy, can identify lesions in the process for evaluation and diagnosis for children at risk for ASD. Little is known about predictors that influence key steps in this process. We performed a retrospective chart review of 110 children under age five years from an academic medical center with social communication concerns. We assessed predictors of age of referral for ASD diagnostic evaluation, time to diagnosis, and likelihood of diagnostic completion. Children with continuity of primary care were referred at an earlier age than those receiving primary care at multiple centers. Compared with children with missed visits, children attending all well-child visits had a shorter median time to diagnosis. These findings illustrate a need for primary medical homes to facilitate early and timely ASD evaluations.

Background Concern with depression during the perinatal period has resulted in multiple states enacting legislation to require universal screening of mothers for postpartum depression. Despite this concern, rates of women receiving mental health counseling during pregnancy and postpartum remain low. This study examines factors, especially inequities in race/ethnicity, associated with receiving perinatal mental health counseling. Methods This study draws on data from the Listening to Mothers in California survey of 2539 women, based on a representative sample of birth certificate files of women who gave birth in 2016. The survey included a series of mental health questions, based on the 4-item Patient Health Questionnaire (PHQ-4), and questions on the receipt of counseling, whether a practitioner asked respondents about their mental health, and whether the respondent was taking medications for anxiety or depression. Results We found non-Latina Black women to experience both higher rates of prenatal depressive symptoms and significantly lower use of postpartum counseling services and medications than non-Latina White women. Among women with depressive symptoms, those asked by a practitioner about their mental health status reported a 46% rate of counseling compared with 20% who were not asked, and in a multivariable analysis, those asked were almost six times more likely (aOR 5.96; 95% CI 1.6-21.7) to report counseling. Discussion These findings lend evidence to those advocating for state laws requiring universal screening for depressive symptoms to reduce inequities and help address the underuse of counseling services among all women with depressive symptoms, particularly women of color.

OBJECTIVE To identify factors associated with referral and enrollment in early intervention (EI) for infants with neonatal abstinence syndrome (NAS). METHODS We conducted a retrospective cohort study of 256 infants born with NAS (2006-2013) at a tertiary care hospital in (Springfield), Massachusetts, linking maternal-infant birth hospitalization records with Department of Public Health EI records. We calculated the percent of infants retained at each step in the EI enrollment process over the first 3 years of life. We conducted separate multivariable logistic regression analyses to identify factors associated with EI referral and enrollment. RESULTS Among mothers, 82% received medication-assisted treatment at delivery, 36% endorsed illicit drug use during pregnancy, and 76% retained custody of their child at discharge. Among infants, 77% were referred to EI and 48% were enrolled in services. Of infants discharged to biological parents, 81% were referred to EI versus 66% of infants discharged to foster care (p ≤ 0.05); this difference persisted in multivariable analysis [adjusted odds ratio, 2.30; 95% confidence interval (CI), 1.09-4.86]. Infants in the highest tertile for length of stay had 2.70 times the odds of EI enrollment (95% CI, 1.37-5.31). CONCLUSION Fewer than half of the eligible infants with NAS were enrolled in EI services. Discharge to a biological parent and longer hospital stay had the strongest associations with EI referral and enrollment, respectively. Efforts to improve EI referral rates during the birth hospitalization, particularly among infants discharged into foster care, and close follow-up for infants with shorter hospital stays would enhance the developmental supports for this vulnerable population.

Significant disparities exist between Hispanic and non-Hispanic families in time-to-diagnosis among children identified as at risk of autism spectrum disorder; yet, little is known about parent experiences throughout the diagnostic process that may contribute to or help explain these disparities. The current study examined longitudinal trajectories of parenting stress, coping, and perceived family impact during the autism spectrum disorder diagnostic process among an ethnically and racially diverse low-income, urban sample, allowing for comparisons between Hispanic and non-Hispanic families. Hispanic families reported lower levels of parenting stress (χ2 = 5.35(1), p = 0.021), avoidant (χ2 = 9.66(1), p = 0.002) and approach (χ2 = 8.61(1), p = 0.003) coping, and negative family impact (χ2 = 5.39(1), p = 0.020) across time (main effects) compared with non-Hispanic families. Furthermore, there were differences in the change in use (Time Period × Ethnicity interaction effects) of both avoidant (χ2 = 10.80(3), p = 0.013) and approach (χ2 = 11.57(3), p = 0.009) coping, as well as negative family impact (χ2 = 9.81(3), p = 0.020), between Hispanic and non-Hispanic parents over time. These differences begin to shed light on the unique experiences of Hispanic parents. Because of the strengths that Hispanic families demonstrate, interventions that leverage those strengths and focus on education, empowerment, and resilience might be particularly beneficial for Hispanic families and may also better inform work to increase resilience in non-Hispanic families. Lay abstract Little is known about parent experiences throughout the diagnostic process for autism or how these parent experiences may help explain the disparities that exist between Hispanic and non-Hispanic families in time-to-diagnosis among children identified as at risk for autism. The current study examined trajectories of parenting stress, coping, and perceived family impact over time, throughout the autism diagnostic process among Hispanic and non-Hispanic families. Hispanic families reported lower levels of parenting stress, coping, and negative family impact across time. Further, there were differences in the change in use of coping and the amount of negative family impact reported between Hispanic and non-Hispanic parents over time. These differences shed light on the unique experiences and strengths of Hispanic families demonstrate. Interventions that leverage those strengths and focus on education, empowerment, and resilience might be particularly beneficial for Hispanic families and may also better inform work to increase resilience.

This study aimed to define the core components of Family Navigation for autism spectrum disorder, a promising intervention to reduce disparities in care for this population. Teams from four trials of Family Navigation for autism spectrum disorder completed the Template for Intervention Description and Replication checklist to outline intervention components. Through intervention component analysis and qualitative synthesis, we identified 11 core components across three domains: Training and Supervision, Navigator Tools, and Navigator Activities. We discuss the importance of identifying these core components and implications for future research and practice.

Objective Depression is highly prevalent among caregivers of children with attention-deficit/hyperactivity disorder (ADHD). We examined the association between caregiver depressive symptom trajectories and changes in child ADHD symptoms. Methods We analyzed data from a randomized trial of 2 ADHD care management systems for children aged 6 to 12 years and their caregivers (n = 156 dyads). Child ADHD symptoms were measured using the Swanson, Nolan, and Pelham rating scale (SNAP-IV). Caregiver depressive symptoms were measured using the Quick Inventory of Depressive Symptomatology (QIDS). Measures were assessed at baseline, 6 months, and 12 months. We used multivariable models to examine associations between changes in caregiver depressive symptoms and changes in child ADHD symptoms. Results From baseline to 12 months, children of caregivers with improved depressive symptoms had significantly greater reductions in SNAP-IV scores (change score: -1.43) compared with those whose depressive symptoms did not change (change score: -0.97) or worsened (change score: -0.23, p = 0.003). In adjusted models, improved caregiver depressive symptoms were associated with greater reductions in SNAP-IV scores over the 12-month period. Compared with those with worsening caregiver depressive symptoms, children whose caregivers showed no significant changes in depressive symptoms had a -0.78 point (95% confidence interval [CI]: -1.40 to -0.17) greater reduction in the SNAP-IV score, and those children whose caregiver depressive symptoms improved had a -1.31 point greater reduction in the SNAP-IV score (95% CI: -1.97 to -0.66). Conclusion Given the longitudinal association between caregiver depressive symptom and child ADHD symptom trajectories, interventions that address the behavioral health needs of the family unit may offer promise for urban children with ADHD.

In 2013, the National Institute of Mental Health funded five trials of unique, multicomponent, systems-based innovations designed to improve access to early screening, diagnosis, and treatment of autism spectrum disorder—collectively known as the Autism Spectrum Disorder Pediatric, Early Detection, Engagement, and Services Network. As part of an ongoing effort to pool data and learn from shared experience, we collected information across all studies about innovation components and implementation strategies. First, each study group completed standardized checklists based on the Template for Intervention Description and Replication and the Expert Recommendation for Implementing Change. Then, we interviewed principal and co-investigators of each study (n = 9) to further explore innovation components and assess barriers and facilitators to implementation. Innovation strategies were diverse (five different autism spectrum disorder screeners were used, 40% included early intervention trainings, 60% involved new technology). Common implementation strategies included developing stakeholder relationships and provider trainings. Barriers included inefficient systems of care, difficulty engaging families in the innovations, provider attitudes, and organizational culture (e.g. difficulty changing clinic processes). These findings suggest that—despite diverse settings and a variety of innovation content—common facilitators and challenges exist in implementing innovations to enhance access to early autism spectrum disorder screening, diagnosis, and treatment.

OBJECTIVES: Family Navigation (FN), a care management strategy, helps families overcome systems and person-level barriers to care. We previously demonstrated FN’s feasibility, acceptability, and potential efficacy for increasing access and reducing time to autism-related diagnostic services among low-income, minority children. In this paper, we describe modifications to FN in response to concerns raised in our first pilot randomized controlled trial (RCT), and then assess these modifications in a second pilot RCT. METHODS: An advisory group recommended modifications to recruitment procedures and study conditions. 40 parent-child dyad participants with autism-related concerns were randomized to receive modified usual care (UC) or modified FN. We compared whether the first and second pilot RCTs differed in: participant enrollment, satisfaction with clinical care, and timely completion of the diagnostic assessment. RESULTS: Recruitment improved under the modified protocol with significantly fewer potentially eligible families refusing (19.5% vs. 4.8%, p < .05) or being excluded from study enrollment (43.6% vs. 0%, p < 0.01). Comparing the first and second pilot RCTs, regardless of study arm, families in the second pilot were more likely to complete diagnostic assessment (UC: HR 3.41, 95% CI [1.20, 9.68]; FN: HR 2.64, 95% CI [1.31, 5.30]) and report greater satisfaction with clinical care. In the second pilot, compared to UC, FN continued increase the likelihood of completing the diagnostic assessment (HR: 2.57; 95% CI [1.22, 5.40]). CONCLUSIONS: Easy-to-implement system-level enhancements improved study recruitment, satisfaction with care, and completion of a diagnostic assessment. With enhancement, FN continued to confer benefits to families.

Importance Early identification of autism spectrum disorder (ASD) is associated with improved cognitive and behavioral outcomes. Targeted strategies are needed to support equitable access to diagnostic services to ensure that children from low-income and racial/ethnic minority families receive the benefits of early ASD identification and treatment. Objective To test the efficacy of family navigation (FN), an individually tailored, culturally informed care management strategy, to increase the likelihood of achieving diagnostic ascertainment among young children at risk for ASD. Design, Setting, and Participants This randomized clinical trial of 249 families of children aged 15 to 27 months who had positive screening results for possible ASD was conducted in 11 urban primary care sites in 3 cities. Data collection occurred from February 24, 2015, through November 5, 2018. Statistical analysis was performed on an intent-to-treat basis from November 5, 2018, to July 27, 2020. Interventions Families were randomized to FN or conventional care management (CCM). Families receiving FN were assigned a navigator who conducted community-based outreach to families to address structural barriers to care and support engagement in recommended services. Families receiving CCM were assigned to a care manager, who did limited telephone outreach. Families received FN or CCM after positive initial screening results and for 100 days after diagnostic ascertainment. Main Outcomes and Measures The primary outcome, diagnostic ascertainment, was measured as the number of days from randomization to completion of the child's clinical developmental evaluation, when a diagnosis of ASD or other developmental disorder was determined. Results Among 250 families randomized, 249 were included in the primary analysis (174 boys [69.9%]; mean [SD] age, 22.0 [3.5] months; 205 [82.3%] publicly insured; 233 [93.6%] non-White). Children who received FN had a greater likelihood of reaching diagnostic ascertainment over the course of 1 year (FN, 108 of 126 [85.7%]; CCM, 94 of 123 [76.4%]; unadjusted hazard ratio [HR], 1.39 [95% CI, 1.05-1.84]). Site (Boston, New Haven, and Philadelphia) and ethnicity (Hispanic vs non-Hispanic) moderated the effect of FN (treatment × site interaction; P = .03; Boston: HR, 2.07 [95% CI, 1.31-3.26]; New Haven: HR, 1.91 [95% CI, 0.94-3.89]; and Philadelphia: HR, 0.91 [95% CI, 0.60-1.37]) (treatment × ethnicity interaction; P

There is growing interest in Family Navigation as an approach to improving access to care for children with autism spectrum disorder, yet little data exist on the implementation of Family Navigation. The aim of this study was to identify potential failures in implementing Family Navigation for children with autism spectrum disorder, using a failure modes and effects analysis. This mixed-methods study was set within a randomized controlled trial testing the effectiveness of Family Navigation in reducing the time from screening to diagnosis and treatment for autism spectrum disorder across three states. Using standard failure modes and effects analysis methodology, experts in Family Navigation for autism spectrum disorder (n = 9) rated potential failures in implementation on a 10-point scale in three categories: likelihood of the failure occurring, likelihood of not detecting the failure, and severity of failure. Ratings were then used to create a risk priority number for each failure. The failure modes and effects analysis detected five areas for potential “high priority” failures in implementation: (1) setting up community-based services, (2) initial family meeting, (3) training, (4) fidelity monitoring, and (5) attending testing appointments. Reasons for failure included families not receptive, scheduling, and insufficient training time. The process with the highest risk profile was “setting up community-based services.” Failure in “attending testing appointment” was rated as the most severe potential failure. A number of potential failures in Family Navigation implementation—along with strategies for mitigation—were identified. These data can guide those working to implement Family Navigation for children with autism spectrum disorder.

* Abbreviations: ASD — : autism spectrum disorder ASQ — : Ages and Stages Questionnaire EAS — : Emotionality, Activity, and Sociability Temperament Survey MCHAT — : Modified Checklist for Autism in Toddlers MCHAT-R — : Modified Checklist for Autism in Toddlers-Revised USPSTF — : United States Preventive Services Task Force Although autism spectrum disorder (ASD) can be reliably detected by age 2, the average age of diagnosis ranges from age 4 to 6, depending on the population.1 Because earlier access to treatment is thought to improve outcomes,2 delays in diagnosis may lead to avoidable morbidity. In an effort to lower the average age of diagnosis, considerable efforts are being made to promote early ASD screening.3–5 Two predominant strategies exist: broad-based developmental surveillance and targeted ASD screening.6,7 Although there are data to support each strategy, targeted ASD screening has recently gained popularity. The American Academy of Pediatrics, for example, recommends all children receive an ASD-specific screener at their 18- and 24-month well-child visit, and it proactively supports these guidelines with resources and trainings.3 A number of studies support ASD-specific screeners (the Modified Checklist for Autism in Toddlers [MCHAT] and the Modified Checklist for Autism in Toddlers-Revised [MCHAT-R]) for detecting early ASD … Address correspondence to Sarabeth Broder-Fingert, MD, MPH, Division of General Pediatrics, Boston University School of Medicine, 850 Harrison Ave, Room 310A, Boston, MA 02118. E-mail: sarabeth.broder-fingert{at}bmc.org

Significant racial, ethnic, and socioeconomic disparities exist in access to evidence-based treatment services for children with autism spectrum disorder (ASD). Patient Navigation (PN) is a theory-based care management strategy designed to reduce disparities in access to care. The purpose of this study is to test the effectiveness of PN a strategy to reduce disparities in access to evidence-based services for vulnerable children with ASD, as well as to explore factors that impact implementation. This study uses a hybrid type I randomized effectiveness/implementation design to test effectiveness and collect data on implementation concurrently. It is a two-arm comparative effectiveness trial with a target of 125 participants per arm. Participants are families of children age 15–27 months who receive a positive screen for ASD at a primary care visit at urban clinics in Massachusetts (n = 6 clinics), Connecticut (n = 1), and Pennsylvania (n = 2). The trial measures diagnostic interval (number of days from positive screen to diagnostic determination) and time to receipt of evidence-based ASD services/recommended services (number of days from date of diagnosis to receipt of services) in those with PN compared to and activated control -Conventional Care Management – which is similar to care management received in a high quality medical home. At the same time, a mixed-method implementation evaluation is being carried out. This study will examine the effectiveness of PN to reduce the time to and receipt of evidence-based services for vulnerable children with ASD, as well as factors that influence implementation. Findings will tell us both if PN is an effective approach for improving access to evidence-based care for children with ASD, and inform future strategies for dissemination. NCT02359084 Registered February 1, 2015.

Children with autism spectrum disorder (ASD) are at high risk for being overweight and obese. Little is known about how obesity in children with ASD is being addressed in primary care. This article reports findings from a survey completed by 327 general pediatricians, which included a fictional clinical vignette and Likert-scales assessing attitudes, practices, self-efficacy, and barriers to obesity management. Although the majority of respondents agreed pediatricians should be the main providers to manage obesity in children with ASD, few reported receiving adequate training to do so. Pediatricians were more likely to refer to developmental-behavioral pediatricians and dietitians for a child with ASD compared to a child without ASD. Higher self-efficacy was associated with increased weight-related counseling frequency by pediatricians.

OBJECTIVES: Although many attention-deficit/hyperactivity disorder (ADHD) care models have been studied, few have demonstrated individual-level symptom improvement. We sought to test whether complementing basic collaborative care with interventions that address common reasons for symptom persistence improves outcomes for children with inattention and hyperactivity/impulsivity. METHODS: We conducted a randomized comparative effectiveness trial of 2 care management systems for 6- to 12-year-old children being evaluated for ADHD (n = 156). All participants received care management with decision support. Care managers in the enhanced care arm also were trained in motivational and parent management techniques to help parents engage in their child’s treatment, address their own mental health needs, and manage challenging child behaviors. We used multivariable models to assess inattention, hyperactivity/impulsivity, oppositionality, and social skills over 1 year. RESULTS: Both treatment arms generated guideline concordant diagnostic processes in 94% of cases; 40% of children had presentations consistent with ADHD. For the entire sample, there were no differences in symptom trajectories between study arms; mean differences in change scores at 12 months were –0.14 (95% confidence interval –0.34 to 0.07) for inattention; –0.13 (–0.31 to 0.05) for hyperactivity/impulsivity; –0.09 (–0.28 to 0.11) for oppositionality; and 3.30 (–1.23 to 7.82) for social skills. Among children with ADHD-consistent presentations, enhanced arm participants experienced superior change scores for hyperactivity/impulsivity of –0.36 (–0.69 to –0.03), oppositionality –0.40 (–0.75 to –0.05), and social skills 9.57 (1.85 to 17.28). CONCLUSIONS: Among children with ADHD-consistent presentations, addressing barriers to engagement with care and challenging child behaviors has potential to improve the effectiveness of collaborative care.

Emerging evidence suggests that autism spectrum disorder (ASD) can be diagnosed by age 18 months and that early intensive behavioral intervention positively affects ASD core deficits. This pilot randomized controlled trial examined the feasibility of using an adapted form of patient navigation, Family Navigation (FN), to improve timely diagnosis of ASD in low-income families from racial-ethnic minority groups.Forty children referred for an ASD diagnostic assessment were randomly allocated to receive FN or usual care. The primary outcome, time to diagnostic resolution, was assessed with survival analysis.Nineteen of 20 FN children completed the diagnostic assessment, compared with 11 of 19 children receiving usual care (hazard ratio=3.21, 95% confidence interval=1.47-6.98, p.01). In regard to engagement of participants, 17 of 20 families (85%) met with the navigator for the targeted three in-person visits (median=4, range 1-9).FN may be a promising intervention to address barriers that impede timely ASD diagnosis.

The purpose of this Letter to the Editor is to discuss the recent paper, “Lessons learned: Engaging culturally diverse families in neurodevelopmental disorders intervention research” by Ratto et al. Specifically, we are interested in further exploring the question of “who participates in autism spectrum disorder intervention research,” and how this question may impact interpretation of Ratto and colleagues’ paper.

We sought to assess the feasibility and document key study processes of a problem-solving intervention to prevent depression among low-income mothers of preterm infants. A randomized controlled pilot trial (n = 50) of problem-solving education (PSE) was conducted. We assessed intervention provider training and fidelity; recruitment and retention of subjects; intervention acceptability; and investigators' ability to conduct monthly outcome assessments, from which we could obtain empirical estimates of depression symptoms, stress, and functioning over 6 months. Four of four bachelor-level providers were able to deliver PSE appropriately with standardized subjects within 4 weeks of training. Of 12 randomly audited PSE sessions with actual subjects, all met treatment fidelity criteria. Nineteen of 25 PSE subjects (76%) received full four-session courses; no subjects reported negative experiences with PSE. Eighty-eight percent of scheduled follow-up assessments were completed. Forty-four percent of control group mothers experienced an episode of moderately severe depression symptoms over the follow-up period, compared to 24% of PSE mothers. Control mothers experienced an average 1.19 symptomatic episodes over the 6 months of follow-up, compared to 0.52 among PSE mothers. PSE appears feasible and may be a promising strategy to prevent depression among mothers of preterm infants.

Importance The prevalence of psychological distress among mothers of children with autism spectrum disorder (ASD) suggests a need for interventions that address parental mental health during the critical period after the child’s autism diagnosis when parents are learning to navigate the complex system of autism services. Objective To investigate whether a brief cognitive behavioral intervention, problem-solving education (PSE), decreases parenting stress and maternal depressive symptoms during the period immediately following a child’s diagnosis of ASD. Design, Setting, and Participants A randomized clinical trial compared 6 sessions of PSE with usual care. Settings included an autism clinic and 6 community-based early intervention programs that primarily serve low-income families. Participants were mothers of 122 young children (mean age, 34 months) who recently received a diagnosis of ASD. Among mothers assessed for eligibility, 17.0% declined participation. We report outcomes after 3 months of follow-up (immediate postdiagnosis period). Interventions Problem-solving education is a brief, cognitive intervention delivered in six 30-minute individualized sessions by existing staff (early intervention programs) or research staff without formal mental health training (autism clinic). Main Outcomes and Measures Primary outcomes were parental stress and maternal depressive symptoms. Results Fifty-nine mothers were randomized to receive PSE and 63 to receive usual care. The follow-up rate was 91.0%. Most intervention mothers (78.0%) received the full PSE course. At the 3-month follow-up assessment, PSE mothers were significantly less likely than those serving as controls to have clinically significant parental stress (3.8% vs 29.3%; adjusted relative risk [aRR], 0.17; 95% CI, 0.04 to 0.65). For depressive symptoms, the risk reduction in clinically significant symptoms did not reach statistical significance (5.7% vs 22.4%; aRR, 0.33; 95% CI, 0.10 to 1.08); however, the reduction in mean depressive symptoms was statistically significant (Quick Inventory of Depressive Symptomatology score, 4.6 with PSE vs 6.9 with usual care; adjusted mean difference, −1.67; 95% CI, −3.17 to −0.18). Conclusions and Relevance The positive effects of PSE in reducing parenting stress and depressive symptoms during the critical postdiagnosis period, when parents are asked to navigate a complex service delivery system, suggest that it may have a place in clinical practice. Further work will monitor these families for a total of 9 months to determine the trajectory of outcomes. Trial Registration clinicaltrials.gov Identifier:NCT01021384