Reducing Disparities in Behavioral Health Treatment for Children in Primary Care

NCT04082234 | Active Not Recruiting

• 1 other identifier: 19-016315
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

Behavior Therapy; Integrated Primary Care; Reducing Disparities

Outcome Measures

Primary Outcomes (6)

• Changes in Homework Performance

  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.

  Baseline, 8-weeks (mid-treatment), 16-weeks (post-treatment), 32-weeks (follow-up)

• Changes in Behavior Compliance

  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.

  Baseline, 8-weeks (mid-treatment; parent only), 16-weeks (post-treatment), 32-weeks (follow-up)

• Changes in Symptoms of ADHD and Emotional and Behavioral Problems

  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.

  Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)

• Changes in Peer Relationships

  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.

  Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)

• Changes in Life Satisfaction

  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 \[from 2.5 standard deviations (SDs) below the mean to 1 SD above the mean\].

  Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)

• Changes in Service Use

  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.

  Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)

Secondary Outcomes (10)

• Changes in Parent-Child Relationship

  Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)

• 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)

• Satisfaction with Treatment

  16-weeks (post-treatment)

Study Arms (2)

Integrated Individualized Behavioral Parent Training

EXPERIMENTAL

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.

Behavioral: Partnering to Achieve School Success (PASS)

Treatment as Usual

ACTIVE COMPARATOR

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.

Other: Treatment as Usual (TAU)

Interventions

Partnering to Achieve School Success (PASS) BEHAVIORAL

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.

Integrated Individualized Behavioral Parent Training

Treatment as Usual (TAU) OTHER

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.

Treatment as Usual

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Mautone JA, Holdaway A, Chan W, Michel JJ, Guevara JP, Davis A, Desrochers C, Evans E, Gajary Z, Leavy S, Rios D, Tremont KL, Cacia J, Schwartz BS, Jawad AF, Power TJ. 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. BMC Prim Care. 2024 Jun 22;25(1):225. doi: 10.1186/s12875-024-02473-7.

  PMID: 38909215 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jennifer A Mautone, PhD, NCSP, ABPP

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Thomas J Power, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: November 1, 2019
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become accessible after the study is completed, the Final Research Report has been accepted by PCORI, and results have been published in a peer-reviewed journal. Data will be available for at least 7 years from that time, per PCORI guidelines.
• Access Criteria: Individuals interested in using the data should contact Dr. Thomas Power (power@chop.edu). When our research team receives a request for access to the data a data file and supporting documentation will be prepared by the research team. Only de-identified data will be made accessible in order to prevent identification of children, caregivers, teachers, and PCPs who participated in this project. Therefore, per Children's Hospital of Philadelphia (CHOP) policies, a data licensing agreement is anticipated to not be necessary.

Locations

US (1)