Workforce and System Change to Treat Adolescent Opioid Use Disorder Within Integrated Pediatric Primary Care
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Indiana University
- Study ID
- NCT06477848
- Status
- Enrolling By Invitation
Conditions
- Adolescent
- Opioid Use Disorder
- Substance Use Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Integrated Behavioral Health System with SUD Resources — OTHERThis is a system-level intervention designed to improve collaboration among personnel from primary care clinics and SUD resources.
Study Details
This project seeks to address the increasing risk of overdose death, substance use disorder (SUD), and opioid use disorder (OUD) in adolescents. The investigators believe that pediatric primary care providers (PCP) could play an important role in helping youth with SUD because most adolescents see their PCPs for annual wellness visits. However, PCPs have many barriers to treating their young patients with SUD/OUD: lack of training, resources, and support to deliver SUD/OUD services, limited time with patients, and the only available referral options often come with long wait times for an appointment. Through this project, the investigators will build upon an existing Integrated Behavioral Health (IBH) system by offering stigma-reduction interventions and brief SUD interventions within primary care settings. The goal of this project is to learn if clinics participating in an Integrated Behavioral Healthcare Program with SUD resources will increase delivery of effective adolescent SUD care and ultimately lead to better health outcomes when compared to standard primary care treatment. During the first project phase, the research team will gather a Parent and Youth Advisory Board, Primary Care Provider Advisory Board, and Integrated Care Expert Panel (Aim 1) to inform the development and refinement of the primary care-based SUD interventions. The investigators will gather input from national experts, local stakeholders, and PCPs to refine our screening to treatment approach (Aim 2), coupled with stigma reduction activities, within pediatric primary care. During the second project phase, researchers will assess the impact of SUD IBH on PCP behaviors around adolescent SUD intervention. The investigators will interview and survey PCPs, clinic managers, and other clinical staff for willingness to engage in adolescent SUD treatment. The investigators will evaluate implementation outcomes (views toward SUD, stigma attitudes, IBH team dynamics; Aim 3) and effectiveness/reach outcomes (delivery of integrated primary care-based SUD services, the use of brief interventions for adolescents, number of consultation calls, and increased treatment engagement; Aim 4a), along with an exploratory test of local overdose rates for youth (Aim 4b), in order to examine local effects of the new intervention. This project is supported by the HEAL Initiative (https://heal.nih.gov/).
Key Dates
- Start date
- Feb 21, 2025
- Status verified
- Apr 2025
- Primary completion
- Aug 31, 2028
- Completion
- Aug 31, 2028
Study Design
- Enrollment
- 400 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- No Intervention: Primary Care Practice As UsualData are collected regarding standard primary care practice and outcomes before implementation of SUD resources within the Integrated Behavioral Health System.
- Experimental: Integrated Behavioral Health with SUD ResourcesParticipating clinics receive a system-level intervention, an Integrated Behavioral Health System with SUD Resources, designed to improve youth connection to substance use treatment.
Primary Outcome Measure
Evidence-Based Practice Attitudes Scale [ Time Frame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | - |
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