Reducing disparities in behavioral health treatment in pediatric primary care: a randomized controlled trial comparing Partnering to Achieve School Success (PASS) to usual ADHD care for children ages 5 to 11 - study protocol.

BACKGROUND: Integrating behavioral health services into pediatric primary care can improve access to care, especially for children marginalized by poverty and racial/ethnic minority status. In primary care, a common presenting concern is attention-deficit/hyperactivity disorder (ADHD). Services in primary care for marginalized children with ADHD typically include medication alone; therapy to improve skills and build relationships is less available. This study evaluates the effectiveness of a behavioral intervention offered through primary care for marginalized families coping with ADHD (Partnering to Achieve School Success, PASS) compared to treatment as usual (TAU). METHOD: Three hundred participants will be randomly assigned to PASS or TAU. Participants include children ages 5 to 11 who have ADHD and are from economically marginalized families. PASS is a personalized, enhanced behavioral intervention that includes evidence-based behavior therapy strategies and enhancements to promote family engagement, increase caregiver distress tolerance, and provide team-based care to improve academic and behavioral functioning. TAU includes services offered by primary care providers and referral for integrated behavioral health or community mental health services. Outcomes will be assessed at mid-treatment (8 weeks after baseline), post-treatment (16 weeks), and follow-up (32 weeks) using parent- and teacher-report measures of service use, child academic, behavioral, and social functioning, parenting practices, family empowerment, and team-based care. Mixed effects models will examine between-group differences at post-treatment and follow-up. Analyses will examine the mediating role of parenting practices, family empowerment, and team-based care. Subgroup analyses will examine differential effects of intervention by child clinical characteristics and socioeconomic factors. DISCUSSION: This study is unique in targeting a population of children with ADHD marginalized by low socioeconomic resources and examining an intervention designed to address the challenges of families coping with chronic stress related to poverty. TRIAL REGISTRATION: This study was registered on clinicaltrials.gov (NCT04082234) on September 5, 2019, prior to enrollment of the first participant. The current version of the protocol and IRB approval date is October 4, 2023. Results will be submitted to ClinicalTrials.gov no later than 30 days prior to the due date for the submission of the draft of the final research report to the Patient-Centered Outcomes Research Institute.

Improving Care Management in Attention-Deficit/Hyperactivity Disorder: An RCT.

OBJECTIVES: To compare the effectiveness of care management combined with a patient portal versus a portal alone for communication among children with attention-deficit/hyperactivity disorder (ADHD). METHODS: Randomized controlled trial conducted at 11 primary care practices. Children aged 5 to 12 years old with ADHD were randomly assigned to care management + portal or portal alone. The portal included parent-reported treatment preferences and goals, medication side effects, and parent- and teacher-reported ADHD symptom scales. Care managers provided education to families; communicated quarterly with parents, teachers, and clinicians; and coordinated care. The main outcome, changes in the Vanderbilt Parent Rating Scale (VPRS) score as a measure of ADHD symptoms, was assessed using intention-to-treat analysis. RESULTS: A total of 303 eligible children (69% male; 46% Black) were randomly assigned, and 273 (90%) completed the study. During the 9-month study, parents in the care management + portal arm communicated inconsistently with care managers (mean 2.2; range 0-6) but similarly used the portal (mean 2.3 vs 2.2) as parents in the portal alone arm. In multivariate models, VPRS scores decreased over time (Adjusted ß = -.015; 95% confidence interval -0.023 to -0.07) in both groups, but there were no intervention-by-time effects (Adjusted ß = .000; 95% confidence interval -0.011 to 0.012) between groups. Children who received ≥2 care management sessions had greater reductions in VPRS scores than those with fewer sessions. CONCLUSIONS: Results did not provide evidence that care management combined with a patient portal was different from portal use alone among children with ADHD. Both groups demonstrated similar reductions in ADHD symptoms. Those families with greater care management engagement demonstrated greater reductions than those with less engagement.