Integrated Treatment for Enhancing Growth in Recovery During Adolescence

Last updated: November 20, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Addictions

Substance Abuse

Alcohol Use Disorder

Treatment

InTEGRA

MET/CBT

Clinical Study ID

NCT06395467
2023P000727
R01AA030926
  • Ages 14-21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. 14-21 years old

  2. SUD based on criteria from the Diagnostic and Statistical Manual of MentalDisorders, 5th Edition (DSM-5)

  3. able to read and comprehend English at a 5th-grade level

  4. residence in New England (Massachusetts, Connecticut, Rhode Island, Vermont, NewHampshire, Maine) or New York

  5. any AOD use in the past 90 days (or in the 90 days prior to being in a controlledenvironment)

  6. meet patient placement criteria for level I (outpatient) treatment

  7. participant and a family member/guardian responsible for providing collateralinformation (for those <18 years) agree to sign Institutional Review Board (IRB)-approved consent

  8. participant and family member responsible for providing collateral information whocould be contacted in case the subject became lost to follow-up.

Exclusion

Exclusion criteria:

  1. suicidal ideation with a plan, suicidal behavior, a plan to hurt oneself or others,or a history of self-injurious behavior occurring in past 30 days

  2. lifetime diagnosis of schizophrenia

  3. current health condition (i.e., medical, psychiatric) that compromises participant'sability to attend outpatient treatment

  4. demonstrate inability or unwillingness to identify a "locator" who could becontacted in case participant becomes lost to follow-up; or

  5. youth attending another SUD treatment program or receiving psychotherapy that couldconflict with study treatments.

Study Design

Total Participants: 294
Treatment Group(s): 2
Primary Treatment: InTEGRA
Phase:
Study Start date:
November 26, 2024
Estimated Completion Date:
May 31, 2028

Study Description

Interested individuals will be screened by phone, followed by a more rigorous screening completed at intake. With the anticipated sample size of 294, expected enrollment is between 6-7 participants per month across the two sites during the enrollment period (about 3-4 per site).

Participants are randomized to treatment conditions in a 1:1 ratio using a computerized urn randomization program (stratified by age and gender) The study data analyst will share this information with the treatment providers once a given group is ready to begin. The research assistants conducting assessments will be blinded to condition assignment.

Beginning at treatment conclusion (approximately 3 months after enrollment), participants are followed up every 3 months for one year following their baseline enrollment date.

The treatment conditions are InTEGRA, which integrates key elements of TSF with MET/CBT, and MET/CBT alone.

Connect with a study center

  • UConn Health

    Farmington, Connecticut 06032
    United States

    Site Not Available

  • UConn Health

    Farmington 4834272, Connecticut 4831725 06032
    United States

    Active - Recruiting

  • MGH Department of Psychiatry

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • MGH Department of Psychiatry

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

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