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Trial record 2 of 14 for:    ENGAGE PAS

Reducing Disparities in Behavioral Health Treatment for Children in Primary Care (PASS)

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ClinicalTrials.gov Identifier: NCT04082234
Recruitment Status : Not yet recruiting
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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) plus family education 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.

Condition or disease Intervention/treatment Phase
ADHD Behavioral: Partnering to Achieve School Success (PASS) Other: Treatment as Usual (TAU) plus Family Education Not Applicable

Detailed Description:

Context: Families of children with attention-deficit/hyperactivity disorder (ADHD) often have difficulty getting access to behavior therapy for their children. The 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 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 plus family education. 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 five 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 and in kindergarten through grade 5. Children will be randomly assigned to PASS or TAU plus family education, 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, child, and teacher rating. Secondary outcomes are informant ratings of ADHD symptoms.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Disparities in Behavioral Health Treatment for Children in Primary Care
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : November 15, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Integrated Individualized Behavioral Parent Training
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 9 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)
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 9 to 12 sessions over the course of 16 weeks depending on caregiver goals.

Active Comparator: Treatment as Usual (TAU) plus Family Education
The control condition will be TAU plus family education informed by AAP guidelines for managing ADHD and facilitated by electronic practice supports, which have been successfully incorporated into the EHR to guide primary care providers (PCPs) in implementing ADHD guidelines. AAP guidelines include strategies to educate families about ADHD and evidence-based treatments, engage families in shared decision making, titrate medication, and monitor treatment effects. TAU will be enhanced by providing group psychoeducation to families about ADHD. Family education will be provided in two group sessions for parents and children to allow families opportunities to obtain peer support. Families in TAU plus family education will not receive the components of PASS (i.e., integrated behavior therapy in the practice and enhancements).
Other: Treatment as Usual (TAU) plus Family Education
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, TAU is enhanced by offering two group psychoeducation sessions to families to provide them opportunities to learn about ADHD and ADHD treatment. Behavioral parent training strategies are not included in Family Education sessions.




Primary Outcome Measures :
  1. Changes in Homework Performance [ Time Frame: Baseline, 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.

  2. Changes in Academic Progress [ Time Frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up) ]
    The Academic Progress Report (APR) is a 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.

  3. Changes in Academic Grades [ Time Frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up) ]
    The study team will obtain Academic Grades from student's elementary schools. We will obtain student report card grades for students in both conditions. We will calculate students' grade point average based on report card grades.

  4. Changes in Behavior Compliance [ Time Frame: Baseline, 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 and teachers will complete this measure. The psychometric properties of parent and teacher reports on this measure have been shown to be adequate.

  5. 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 18 ADHD items on 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.

  6. Changes in Peer Relationships [ Time Frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up) ]
    The 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.

  7. 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 SDs below the mean to 1 SD above the mean).

  8. 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.


Secondary Outcome Measures :
  1. Changes in Parent-Child Relationship [ Time Frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up) ]
    The Parent-Child Relationship Questionnaire (PCRQ) will assess parent perceptions of their parenting practices. The Positive Involvement factor (22 items) and Negative/Ineffective Discipline factor (12 items) have been shown to be internally consistent and sensitive to the effects of behavioral intervention.

  2. Changes in Family Empowerment [ Time Frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up) ]
    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.

  3. Changes in Perceptions of Team-Based Care [ Time Frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up) ]
    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.

  4. Changes in Parent-Teacher Involvement [ Time Frame: Baseline, 16-weeks (post-treatment), 32-weeks (follow-up) ]
    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.

  5. Satisfaction with Treatment [ Time Frame: 16-weeks (post-treatment) ]
    Parent satisfaction with PASS and TAU plus Family Education will be assessed using modified versions of the Treatment Evaluation Inventory (TEI).



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children between the ages of 5 and 11 years who are enrolled in kindergarten through 5th grade
  • Children receiving care in one of the five 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
  • Children with one or more areas of impairment (score of 3 or 4 on scale ranging from 1 to 4)
  • Children with at least one parent or legal guardian who is able to understand and speak English
  • Evidence that child may be in a family of low-income status, as indicated by child eligibility for Medicaid or 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 psychological therapy focused on parenting practices from another provider at the time of recruitment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082234


Contacts
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Contact: Alex S Holdaway, PhD 267-279-6873 holdawaya@email.chop.edu
Contact: Jaclyn Cacia, MS 267-426-6015 caciaj@email.chop.edu

Sponsors and Collaborators
Children's Hospital of Philadelphia
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Jennifer A Mautone, PhD, NCSP, ABPP Children's Hospital of Philadelphia
Principal Investigator: Thomas J Power, PhD Children's Hospital of Philadelphia

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT04082234     History of Changes
Other Study ID Numbers: 19-016315
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Per Patient-Centered Outcomes Institute (PCORI) requirements, the Full Data Package will be maintained for at least 7 years after the Final Research Report has been submitted and accepted. The final dataset will be exported from REDCap to Microsoft Excel and commonly used statistical software packages such as SPSS and SAS, as requested by the individuals seeking access to the data. The research team will prepare a codebook to share with the requesting individuals. The codebook will provide information about all of the variables and how the composite variables (e.g. factor scores) were derived.
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@email.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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
Behavior Therapy
Integrated Primary Care
Reducing Disparities