Here is the design of a clinical trial:

Official Title: Reducing Disparities in Behavioral Health Treatment for Children in Primary Care

Included conditions:
- ADHD

Study Armgroups:
- {'label': 'Integrated Individualized Behavioral Parent Training', 'type': 'EXPERIMENTAL', 'description': 'Partnering to Achieve School Success (PASS) is a personalized, enhanced behavioral intervention for ADHD that includes evidence-based behavior therapy strategies and enhancements to promote family engagement in treatment, team-based care, and high quality therapy. Caregivers engage in up to 12 sessions with a behavioral health provider over the course of 16 weeks that are specifically tailored to caregiver goals and values.', 'interventionNames': ['Behavioral: Partnering to Achieve School Success (PASS)']}
- {'label': 'Treatment as Usual', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control condition will be TAU informed by AAP guidelines for managing ADHD and facilitated by electronic practice supports, which have been successfully incorporated into the electronic health record (EHR) to guide primary care providers (PCPs) in implementing ADHD guidelines. At CHOP, PCPs across the primary care network were invited to participate in a distance learning, quality improvement initiative to promote implementation of AAP guidelines, including strategies to educate families about ADHD and evidence-based treatments, engage families in shared decision making, titrate medication, and monitor treatment effects. The six practices participating in this study participated in that project.', 'interventionNames': ['Other: Treatment as Usual (TAU)']}

Interventions:
- {'type': 'BEHAVIORAL', 'name': 'Partnering to Achieve School Success (PASS)', 'description': "Individualized parent training program delivered at child's primary care provider office. Providers use engagement and motivation strategies during each session to reinforce help-seeking behavior and family empowerment, and encourage family adherence to recommended strategies. Also includes regular communication between pass provider and PCP and development of a problem-solving partnership between parents and teachers to address school problems. Families are supported in between sessions by a Community Health Partner who contacts families to promote attendance and implementation of strategies and assist in resolving barriers to treatment. The intervention is up to 12 sessions over the course of 16 weeks depending on caregiver goals.", 'armGroupLabels': ['Integrated Individualized Behavioral Parent Training']}
- {'type': 'OTHER', 'name': 'Treatment as Usual (TAU)', 'description': "Caregivers will work with their primary care physician to address their child's ADHD. Primary care physicians have been trained in and informed of American Academy of Pediatrics guidelines for treating ADHD. Treatment may include strategies to educate families about ADHD and evidence-based treatments, refer families to community mental health agencies that deliver evidence-based behavioral programming (other than PASS), engage families in shared decision making, titrate medication, and monitor treatment effects. In addition, families will have access to integrated behavioral health services that are typically offered at their child's primary care office.", 'armGroupLabels': ['Treatment as Usual']}

Primary Outcomes:
- {'measure': 'Changes in Homework Performance', 'description': 'The Inattention/Task Avoidance factor of the Homework Problem Checklist (HPC) will be used as a parent-report measure of academic performance. This 12-item scale has strong psychometric properties and is responsive to family-school intervention programs.', 'timeFrame': 'Baseline, 8-weeks (mid-treatment), 16-weeks (post-treatment), 32-weeks (follow-up)'}
- {'measure': 'Changes in Behavior Compliance', 'description': 'Behavior compliance will be determined by assessing the severity of disruptive behavior using the eight items pertaining to oppositional-defiant disorder from the Vanderbilt parent scale and four items pertaining to oppositional-defiant disorder (ODD) from the Vanderbilt teacher scale. Both parents (primary outcome) and teachers (secondary outcome) will complete this measure. The psychometric properties of parent and teacher reports on this measure have been shown to be adequate.', 'timeFrame': 'Baseline, 8-weeks (mid-treatment; parent only), 16-weeks (post-treatment), 32-weeks (follow-up)'}
- {'measure': 'Changes in Symptoms of ADHD and Emotional and Behavioral Problems', 'description': 'Severity of ADHD symptoms will be assessed using the Vanderbilt Scales. This measure will be completed by parents and teachers. Parent and teacher ratings of ADHD symptoms have been demonstrated to have excellent psychometric properties and to be sensitive to change in response to treatment. A total symptom score will be used in this study. A child self-report measure of ADHD symptoms will not be included because children with ADHD have been shown to substantially overestimate their competence with regard to paying attention and regulating their behavior. All 18 ADHD symptom items will be completed at Baseline and all 9 ADHD Inattention items and 3 ADHD Hyperactivity/Impulsivity items will be administered at post-treatment and follow-up.', 'timeFrame': 'Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)'}
- {'measure': 'Changes in Peer Relationships', 'description': "The Patient Reported Outcomes Measurement Information System (PROMIS) peer relationships scales will be used to assess child relationships with their peers. The child-report version consists of 8 items and the parent-report measure has 7 items. These measures assess the quality of children's relationships with peers including the degree of peer acceptance. The scales have been shown to produce scores that are both reliable and valid based on analyses using item response theory.", 'timeFrame': 'Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)'}
- {'measure': 'Changes in Life Satisfaction', 'description': "The PROMIS life satisfaction scale consists of a 4-item child-report measure and a 4-item parent-report measure. It assesses children's and parents' evaluations of the quality of the child's life. Using analyses based in item response theory, these scales have been shown to be reliable with a wide range of life satisfaction levels \\[from 2.5 standard deviations (SDs) below the mean to 1 SD above the mean\\].", 'timeFrame': 'Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)'}
- {'measure': 'Changes in Service Use', 'description': "Service use for emotional and behavioral problems will be measured via a service use measure adapted for this study designed to gather information on the child's use of services to treat ADHD. In this study, we will collect data on service utilization in outpatient mental health settings and school settings, and treatment with medication.", 'timeFrame': 'Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)'}

Please estimate the sample size based on the assumption: 
Standard deviation for a single observation is assumed to be 0.50, autocorrelation is 0.3, significance level is not explicitly stated, power is 85%, and the expected attrition rate is 20%.
Sample size
        Based on prior research [26, 28, 35], the magnitude of the effect size reflecting the degree of change in response to PASS vs TAU for service use and child outcomes (Objective 1) and care processes (Objective 2) is expected to be the 0.35 to 0.60 SD range. Based on prior research using a similar behavioral intervention [41], we assumed a standard deviation for a single observationâ=â0.50 and an autocorrelationâ=â0.3. Projecting an enrollment of 300 participants (150 per condition), and given an expected 20% attrition rate, we expect 240 participants will provide parent-report and child self-report data at baseline and at least one other data collection point. Using statistical methods described below, analytic models will achieve 85% power to detect an effect size as small as 0.30 SD. Given the challenges of collecting data from teachers related to the COVID-19 pandemic, the number of evaluable cases will be well below 240 (estimated to be 100). As such, analyses of teacher-report data will be exploratory. In addition, analyses of mediation (Objective 3) and subgroup effects (Objective 4) will be exploratory.