Integrated Treatment for Enhancing Growth in Recovery During Adolescence (InTEGRA)

Mass General Brigham

Status: Enrolling

Conditions: Cannabis Use Disorder; Alcohol Use Disorder

Treatments: Behavioral: InTEGRA; Behavioral: MET/CBT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06395467

2023P000727

R01AA030926 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 294 estimated patients

Sex: All

Ages: 14 to 21 years old

Volunteers: No Healthy Volunteers

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 Massachusetts or Connecticut
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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294 participants in 2 patient groups

InTEGRA

Experimental group

Description:

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.

Treatment:

Behavioral: InTEGRA

MET/CBT

Active Comparator group

Description:

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).

Treatment:

Behavioral: MET/CBT