NCT04499079: ADAPT

Alliances to Disseminate Addiction Prevention and Treatment (ADAPT)

ENROLLING BY INVITATION NA Last updated 18 July 2025

What this trial tests

NA trial testing Learning Health System in Substance-Related Disorders in 12,400 participants. Enrolling by invitation.

Timeline

1 June 2020

Primary endpoint
30 April 2026

30 April 2026

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	12,400
Start date	1 June 2020
Primary completion	30 April 2026
Estimated completion	30 April 2026
Sites	1 location across United States

Drugs / interventions tested

• Learning Health System

Conditions studied

• Substance-Related Disorders — all drugs for Substance-Related Disorders →
• Recidivism — all drugs for Recidivism →
• Opioid-Related Disorders — all drugs for Opioid-Related Disorders →
• Substance Use — all drugs for Substance Use →

Sponsor

Indiana University

Who can join

Adults 11 to 22, any sex, with Substance-Related Disorders or Recidivism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Youth involved in the juvenile justice system (YJJ) bear a disproportionate burden of the addiction crisis. YJJ substance use (SU) is extremely prevalent, with a third of YJJ meeting criteria for a substance use disorder (SUD). The investigators seek to address the national addiction crisis at its epicenter.

Despite their high need for SUD services, and the proliferation of evidence-based interventions to reduce SU, YJJ are rarely connected to needed, high-quality SU care. A care cascade model highlights gaps in YJJ achieving the full continuum of SUD care (i.e., SUD risk identification, treatment referral, treatment initiation, and treatment engagement). YJJ on community supervision/probation face a unique problem accessing SUD services; while the courts or probation may identify YJJ need for SUD care, YJJ must receive care through healthcare agencies in the community. The primary goal of the project, Alliances to Disseminate Addiction Prevention and Treatment (ADAPT) is to address this and other gaps along the care cascade for YJJ. The investigators will accomplish this goal by creating alliances between the juvenile justice system (JJ) agencies and community mental health centers (CMHCs) in eight Indiana counties.

ADAPT takes a two-pronged approach. First, the investigators will employ a Learning Health System (LHS) to develop collaborative alliances between JJ agencies and CMHCs, organizations that traditionally operate independently. Second, the investigators will present local Cascade data during continuous quality improvement cycles within the LHS alliances. By offering agency representatives an opportunity to view and discuss, for example, the local rate at which YJJ with SUD risk are initiating CMHC SU services, the investigators will facilitate development of tailored, local solutions to improve the Cascade for each county's YJJ.

To maximize long-term sustainability of ADAPT's JJ-CMHC alliances, the investigators will conduct this research in collaboration with leaders from an existing statewide initiative, the Juvenile Detention Alternatives Initiative (JDAI). JDAI is a juvenile justice reform effort that utilizes data-driven decision-making and is implemented in almost 300 counties across the US. If this project is successful, the JDAI infrastructure and support for this research will inform sustainment and expansion across Indiana and the nation.

The investigators hypothesize that ADAPT - novel LHS alliances using Cascade data to implement localized solutions to YJJ receiving evidence-based addictions care - will positively impact SU and recidivism outcomes over time. The investigators seek to complete the following specific aims:

AIM 1: Implement LHS alliances between JJ agencies and CMHCs. The investigators will establish LHS alliances: novel, collaborative partnerships between JJ agencies and CMHCs.

AIM 2: Generate and track local solutions to address gaps in the Cascade for YJJ in rural Indiana counties. Quantifying local Cascade data will enable JJ agencies and CMHCs to suggest and implement tailored, evidenced-based interventions, which will be tracked through LHS quality improvement cycles.

AIM 3: Assess implementation outcomes and processes. We will assess implementation outcomes, such as system alliance, among JJ and CHMC personnel using mixed methods.

AIM 4: Assess the impact of ADAPT. Conduct a stepped wedge cluster randomized controlled trial to assess the impact of LHS alliances on the Cascade for YJJ. We will analyze administrative data linked across JJ and health systems to assess the long-term, community-wide effects of ADAPT on public health and safety outcomes (e.g., lower rates of SU-related outcomes and criminal recidivism).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prevention of Opioid Use and Disorder Among Youth Involved in the Legal System: Innovation and Implementation of Four Studies Funded by the NIDA HEAL Initiative.
   Ahrens K, Blackburn N, Aalsma M, Haggerty K, et al · · 2023 · cited 3× · PMID 37393415 · DOI 10.1007/s11121-023-01566-6
2. Early development of local data dashboards to depict the substance use care cascade for youth involved in the legal system: qualitative findings from end users.
   Dir AL, O'Reilly L, Pederson C, Schwartz K, et al · · 2024 · cited 2× · PMID 38816829 · DOI 10.1186/s12913-024-11126-5
3. Learning Health Systems and Substance Use Care Cascade Achievement Among Justice-Involved Youth: A Cluster-Randomized Stepped-Wedge Clinical Trial.
   Aalsma MC, Schwartz K, Sun D, O'Reilly LM, et al · · 2026 · cited 1× · PMID 41665903 · DOI 10.1001/jamanetworkopen.2025.58222
4. Impact of learning health systems on cross-system collaboration between youth legal and community mental health systems: a type II hybrid effectiveness-implementation trial.
   O'Reilly L, Sun D, Schwartz K, Gillenwater L, et al · · 2024 · cited 1× · PMID 39719625 · DOI 10.1186/s43058-024-00686-6
5. Organizational readiness and program sustainability within juvenile justice and community mental health: the mediating role of cross-system collaboration.
   O'Reilly LM, Dir A, Schwartz K, Kim Y, et al · · 2026 · PMID 41964039 · DOI 10.1186/s43058-026-00919-w
6. A descriptive analysis of substance use screening among youth involved in the legal system in eight counties.
   O'Reilly L, Dir A, Schwartz K, Brown S, et al · · 2025 · PMID 41121197 · DOI 10.1186/s13722-025-00609-3