Reducing Disparities in Behavioral Health Treatment for Children in Primary Care
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- ADHD
- Sponsor
- Children's Hospital of Philadelphia
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Changes in Homework Performance
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to address a decisional dilemma faced by health system officials, policy makers, and clinical leaders: "Does it make sense to integrate behavior therapy into primary care practice to treat children with ADHD from low-income settings? More specifically, does integrated care improve access to services and patient-centered outcomes for underserved children with ADHD?" Participants will be randomly assigned to one of two groups: Behavior therapy integrated into primary care (Partnering to Achieve School Success; PASS program) to treatment as usual (TAU) informed by American Academy of Pediatrics (AAP) guidelines for ADHD practice and facilitated by electronic practice supports." Participants will be 300 children (ages 5-11) with ADHD and their caregivers served at Children's Hospital of Philadelphia Care Network Locations (primary care offices). Participants are drawn from primary care locations that serve primarily low-income and racial/ethnic minority population.
Detailed Description
Context: Families of children with attention-deficit/hyperactivity disorder (ADHD) often have difficulty getting access to behavior therapy for their children. This project focuses on children and families of low-income, racial/ethnic minority background, who have particular difficulty getting access to behavior therapy. This study will compare enhanced behavior therapy integrated into primary care (known as Partnering to Achieve School Success \[PASS\]) to treatment as usual (TAU) informed by American Academy of Pediatrics (AAP) guidelines for the treatment of ADHD. In this study, behavior therapy will include components to address the unique needs of low-income families of minority status. Objectives: This project is designed to improve family use of services for ADHD; improve children's academic achievement, behavioral compliance, interpersonal relationships, and life satisfaction; and reduce ADHD symptoms. Study Design: The study is a randomized controlled trial. Setting/Participants: The study is being conducted in seven CHOP primary care practices serving a high percentage of families of low-income, racial/ethnic minority status. Participants will be children ages 5 to 11 with ADHD. Children will be randomly assigned to PASS or TAU, with 150 per group. Study Interventions and Measures: PASS is a behavioral intervention for childhood ADHD that includes behavior therapy strategies and enhancements to promote family engagement in treatment, team-based care, and high-quality therapy. PASS uses a fully integrated service model that includes regular collaboration between the PASS provider and primary care provider (PCP). The primary outcomes are patient-centered outcomes pertaining to child academic achievement, behavior compliance, interpersonal relationships, and life satisfaction, as assessed by parent/legal guardian (or caregiver), and child rating. Secondary outcomes are informant ratings of ADHD symptoms.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children between the ages of 5 and 11 years (as reported in EHR at the time of referral to the study team)
- •Children receiving care in one of the seven targeted CHOP practices for this study
- •Children with an existing diagnosis of ADHD (as indicated by the referring primary care provider or behavioral health provider and/or EHR)
- •Children with one or more areas of impairment (score of 3 or 4 on scale ranging from 1 to 4)
- •Evidence that child may be in a family of low-income status, as indicated by child eligibility for Medicaid or Children's Health Insurance Program (CHIP) OR child living in a census tract or census block with median income at or below two times the federal poverty level
- •Parental/guardian permission (informed consent) and if appropriate, child assent.
Exclusion Criteria
- •Child has autism spectrum disorder
- •Child has an intellectual disability
- •Child has a comorbid condition that is a major clinical concern and requires an alternative form of treatment
- •Child is receiving behavioral health services from another provider at the time of recruitment
- •Child has a sibling currently enrolled in the study
- •Child has received Healthy Minds, Healthy Kids (CHOP's Integrated Behavioral Health Service) in the past 6 months
Outcomes
Primary Outcomes
Changes in Homework Performance
Time Frame: Baseline, 8-weeks (mid-treatment), 16-weeks (post-treatment), 32-weeks (follow-up)
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.
Changes in Behavior Compliance
Time Frame: Baseline, 8-weeks (mid-treatment; parent only), 16-weeks (post-treatment), 32-weeks (follow-up)
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.
Changes in Service Use
Time Frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
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.
Changes in Symptoms of ADHD and Emotional and Behavioral Problems
Time Frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
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.
Changes in Peer Relationships
Time Frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
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.
Changes in Life Satisfaction
Time Frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
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 \[from 2.5 standard deviations (SDs) below the mean to 1 SD above the mean\].
Secondary Outcomes
- Satisfaction with Treatment(16-weeks (post-treatment))
- Acceptability of PASS Delivery Modality(16-weeks (post-treatment))
- Changes in Family Empowerment(Baseline, 16-weeks (post-treatment), 32-weeks (follow-up))
- Changes in Perceptions of Team-Based Care(Baseline, 16-weeks (post-treatment), 32-weeks (follow-up))
- Changes in Parent-Teacher Involvement(Baseline, 16-weeks (post-treatment), 32-weeks (follow-up))
- Changes in Academic Progress(Baseline, 16-weeks (post-treatment), 32-weeks (follow-up))
- Changes in Behavior Compliance(Baseline, 8-weeks (mid-treatment; parent only), 16-weeks (post-treatment), 32-weeks (follow-up))
- Post-Treatment Interview(16-weeks (post-treatment))
- Changes in Parent-Child Relationship(Baseline, 16-weeks (post-treatment), 32-weeks (follow-up))
- Cultural Humility of Provider(16-weeks (post-treatment))