RecruitingNot Applicable

Integrated Treatment for Enhancing Growth in Recovery During Adolescence

United States294 participantsStarted 2024-11-26

Plain-language summary

This is a Phase II parallel group randomized controlled trial with 294 adolescents (age: 14-21 years) with alcohol and other drug \[AOD\] use disorder (hereafter substance use disorder), that compares two different active psychosocial interventions designed to address adolescent substance use disorder. Participants are recruited from our clinical settings and the community at two sites: one in the metro Boston, Massachusetts (MA) area and the other in the metro Farmington, Connecticut (CT), area. Study aims and hypotheses are as follows: 1. To extend the evidence for the initial efficacy of Integrated Treatment for Enhancing Growth in Recovery During Adolescence (InTEGRA), which integrates 12-Step Facilitation (TSF) with Motivational Enhancement Therapy/Cognitive Behavioral Therapy (MET/CBT) relative to gold standard MET/CBT alone (N = 294). It is hypothesized that youth assigned to InTEGRA will have greater 12-step participation during and following treatment, higher abstinence rates, and fewer substance-related negative consequences. 2. Investigate the personal recovery capital (PRC) and social recovery capital (SRC) mechanisms of behavior change through which InTEGRA may confer benefits dynamically over time (e.g., PRC: motivation, self-efficacy, coping; SRC: 12-step involvement; social network changes). 3. Investigate moderators of InTEGRA's effects on outcomes across one-year follow-up (e.g., effect of age, network support for AOD use; psychiatric severity; age composition of 12-step meetings on substance use and substance-related consequences). It is hypothesized that higher network support for AOD use, abstinence motivation, and greater AOD severity, will have a better response to InTEGRA. 4. Explore barriers and facilitators to InTEGRA adoption and implementation across providers and system administrators within the context of a type I hybrid effectiveness-implementation research design.

Who can participate

Age range14 Years – 21 Years

SexALL

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Inclusion criteria

✓. 14-21 years old
✓. SUD based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
✓. able to read and comprehend English at a 5th-grade level
✓. residence in Eastern time zone states (Connecticut, Delaware, Florida, Georgia, Indiana, Kentucky, Maine, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Vermont, Virginia, and West Virginia
✓. any AOD use in the past 90 days (or in the 90 days prior to being in a controlled environment)
✓. meet patient placement criteria for level I (outpatient) treatment
✓. participant and a family member/guardian responsible for providing collateral information (for those \<18 years) agree to sign Institutional Review Board (IRB)-approved consent
✓. participant and family member responsible for providing collateral information who could be contacted in case the subject became lost to follow-up.

Exclusion criteria

What they're measuring

Percent Days Abstinent (PDA)

Timeframe: During treatment and up to 12 months following enrollment

Substance use related consequences

Timeframe: During treatment and up to 12 months following enrollment

Trial details

NCT IDNCT06395467

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05-01

Contact for this trial

Alexandra W Abry, BA

617-724-5259 aabry@mgh.harvard.edu

View on ClinicalTrials.gov More Alcohol Use Disorder trials