Reducing Disparities in Behavioral Health Treatment for Children in Primary Care

ADHD Clinical Trial

— PASS  

Official title:

Reducing Disparities in Behavioral Health Treatment for Children in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04082234
• Other study ID #: 19-016315
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Children's Hospital of Philadelphia
• Contact: Alex S Holdaway, PhD
• Phone: 267-279-6873
• Email: holdawaya[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• Partnering to Achieve School Success (PASS)
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.

Other:
• Treatment as Usual (TAU)
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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Changes in Parent-Child Relationship	The Parent-Child Relationship Questionnaire (PCRQ) will assess parent perceptions of their parenting practices. Four items from the positive Involvement factor and the full Negative/Ineffective Discipline factor (12 items) are included in the current trial.	Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Secondary	Changes in Family Empowerment	Parent empowerment with regard to their knowledge of how to obtain services for their children will be assessed using the Service System factor of the Family Empowerment Scale. This twelve-item scale has been shown to have adequate reliability (alpha=.87; test-retest=.77) and validity.	Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Secondary	Changes in Perceptions of Team-Based Care	To evaluate parental perceptions of team-based care, a seven-item scale was derived from the Clinician and Group Survey, Version 3.0 of the Consumer Assessment of Healthcare Providers and Systems (CAHPS, https://cahps.ahrq.gov/surveys-guidance/cg/about/index.html). The scale includes four Communication and three Care Coordination items.	Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Secondary	Changes in Parent-Teacher Involvement	Items from the Quality of Parent-Teacher Relationship subscale of the Parent-Teacher Involvement Questionnaire (PTIQ) will be used to evaluate the quality of the family-school relationship. The parent version of the form includes 6 items and the teacher version consists of 5 items. Subscales have been validated in families of youth with ADHD and have demonstrated acceptable internal consistency and validity.	Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Secondary	Satisfaction with Treatment	Parent satisfaction with PASS will be assessed using modified versions of the Treatment Evaluation Inventory (TEI).	16-weeks (post-treatment)
Secondary	Acceptability of PASS Delivery Modality	Parent/legal guardian/caregiver satisfaction with the modality of PASS delivery (i.e., in-person or telehealth) will be assessed using a novel Acceptability of PASS Delivery Modality measure.	16-weeks (post-treatment)
Secondary	Cultural Humility of Provider	Parent/legal guardian/caregiver perceptions of PASS provider cultural humility will be assessed using a novel Cultural Humility Measure at post-treatment.	16-weeks (post-treatment)
Secondary	Post-Treatment Interview	Parent/legal guardian/caregivers in the PASS condition will be offered the opportunity to complete a one-time, audio-recorded, qualitative interview at the post-treatment assessment timepoint. This interview will include questions related to perceptions of effectiveness, acceptability, feasibility, and usability of the PASS intervention and the Community Health Partner support, as well as the cultural humility of the PASS provider. The interview will be conducted once and take approximately 40 minutes to complete. Caregivers/legal guardians/parents will be asked to participate (i.e., not children or teachers). Caregivers/legal guardians/parents may participate in this interview whether they received any PASS sessions or not, as long as they had been randomized to the PASS condition and have not withdrawn from the study.	16-weeks (post-treatment)
Secondary	Changes in Academic Progress	The Academic Progress Report (APR) is a parent- and teacher-report measure of academic achievement. The APR assesses proficiency in academic subjects relative to standard expectations (1=Well below standard; 3=At standard; 5=Well above standard). The sum of ratings across academic subjects is the unit of analysis. Reliability is acceptable (alpha = .84), and this measure is sensitive to the effect of behavioral treatments.	Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)
Secondary	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)