Recruiting

Integrated Treatment

Sponsor:

Massachusetts General Hospital

Code:

NCT06395467

Conditions

Alcohol Use Disorder

Cannabis Use Disorder

Eligibility Criteria

Sex: All

Age: 14 - 21

Healthy Volunteers: Not accepted

Interventions

InTEGRA

MET/CBT

Study Details

Brief 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.

Conditions

Alcohol Use Disorder

Cannabis Use Disorder

Study ID

NCT06395467

Start date

Nov 26, 2024

Status verified date

Nov, 2025

Completion date

May 31, 2028

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 21

Healthy Volunteers: Not accepted

Inclusion criteria:

1. 14-21 years old
2. SUD based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
3. able to read and comprehend English at a 5th-grade level
4. 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
5. any AOD use in the past 90 days (or in the 90 days prior to being in a controlled environment)
6. meet patient placement criteria for level I (outpatient) treatment
7. participant and a family member/guardian responsible for providing collateral information (for those <18 years) agree to sign Institutional Review Board (IRB)-approved consent
8. participant and family member responsible for providing collateral information who could be contacted in case the subject became lost to follow-up.

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's ability to attend outpatient treatment
4. demonstrate inability or unwillingness to identify a "locator" who could be contacted in case participant becomes lost to follow-up; or
5. youth attending another SUD treatment program or receiving psychotherapy that could conflict with study treatments.

Study Design

Enrollment

294 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: InTEGRA

10 weekly, in-person or virtual treatment sessions (2 individually-delivered and 8 group sessions). InTEGRA contains many primary treatment elements of MET/CBT, but comparatively less time is spent on these elements to allow for the integration of the TSF content (about 50%). As part of this TSF, for example speakers from 12-step fellowships such as Marijuana Anonymous (MA), Alcoholics Anonymous (AA) and Narcotics Anonymous (NA) are invited to share their experiences and discuss myths and facts related to attendance at 12-step meetings as well as answer any questions participants have about these fellowships. During an orientation session, parents of youth in the InTEGRA condition only (not MET/CBT alone) are given information about the potential benefits of 12-step meeting participation and a list of Young Person's 12-step meetings and encouraged to facilitate their child's participation during and after treatment.

active comparator: MET/CBT

10 weekly, in-person or virtual treatment sessions (2 individually-delivered and 8 group sessions) modified from MET/CBT approaches (Webb, Scudder, Kaminer, \& Kadden, 2002; Sampl \& Kadden 2001) tested in the Cannabis Youth Treatment Study (Dennis et al. 2004).

Interventions

InTEGRA

Session topics are as follows: Parent Info Session - Informational and Q\&A format; Motivation Building- Addressing AA/NA Expectancies and Experiences; AA/NA Expectancies and Treatment Goal Setting Session; Alcohol and Drug Refusal Skills; Coping with Urges and Other Thoughts about Drinking; Problem Solving; Anger Management (AA/NA and Hungry, Angry, Lonely, Tired "HALT"; Effective Communication (Sharing at AA/NA meetings; getting a sponsor); Depression Management; Using AA/NA for enhancing Social Support and Increasing Pleasant Activities; Planning for Emergencies and Coping with Relapse

MET/CBT

Session topics are as follows: Motivation Building Session; Goal Setting Session; Alcohol and Drug Refusal Skills; Coping with Urges and Other Thoughts about Drinking; Problem Solving; Anger Management; Effective Communication; Depression Management; Enhancing the Social Support Network and Increasing Pleasant Activities; Planning for Emergencies and Coping with Relapse

Primary outcome measure

  • Percent Days Abstinent (PDA) [ Time Frame: During treatment and up to 12 months following enrollment ]
  • Substance use related consequences [ Time Frame: During treatment and up to 12 months following enrollment ]

Central Contacts and Locations

Central contacts

Alexandra W Abry, BA

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

Jenny B O'Connor, BA

617-724-7932jboconnor@mgh.harvard.edu

Locations

UConn Health

Recruiting

Farmington, Connecticut, United States, 06032

Contacts

Marla Genova, MA

860.679.8165Genova@uchc.edu

Principal Investigator:

Yifrah Kaminer, MD

MGH Department of Psychiatry

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Alexandra W Abry, BA

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

Jenny B O'Connor, BA

617-724-7932jboconnor@mgh.harvard.edu

Principal Investigator:

John F Kelly, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 6, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-03-06.