Integrated Treatment for Enhancing Growth in Recovery During Adolescence

NCT06395467 | Recruiting DMC

• 2 other identifiers: 2023P000727R01AA030926
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 2

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. 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. 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. 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. 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

Outcome Measures

Primary Outcomes (2)

• Percent Days Abstinent (PDA)

  Percent Days Abstinent (PDA) from alcohol and other drugs (cannabis, opioids, etc.). Derived from Timeline Followback (TLFB) and Form-90 measures of substance use. Abstinence reports confirmed with Breathalyzer and Toxicology Screen data.

  During treatment and up to 12 months following enrollment

• Substance use related consequences

  Substance use related consequences as measured by the Short Inventory of Problems - Revised (SIP-2R), a 15-item measure with response options from 0 to 3 (minimum = 0 and maximum = 45); higher scores correspond with more consequences.

  During treatment and up to 12 months following enrollment

Secondary Outcomes (1)

• Psychiatric symptom severity

  During treatment and up to 12 months following enrollment.

Other Outcomes (1)

• Percent days attending 12-step meetings

  During treatment and up to 12 months following enrollment.

Study Arms (2)

InTEGRA

EXPERIMENTAL

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.

Behavioral: InTEGRA

MET/CBT

ACTIVE COMPARATOR

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).

Behavioral: MET/CBT

Interventions

InTEGRA BEHAVIORAL

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

InTEGRA

MET/CBT BEHAVIORAL

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

MET/CBT

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• lifetime diagnosis of schizophrenia
• current health condition (i.e., medical, psychiatric) that compromises participant's ability to attend outpatient treatment
• demonstrate inability or unwillingness to identify a "locator" who could be contacted in case participant becomes lost to follow-up; or
• youth attending another SUD treatment program or receiving psychotherapy that could conflict with study treatments.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

UConn Health

Farmington, Connecticut, 06032, United States

RECRUITING

MGH Department of Psychiatry

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (12)

• Kelly JF, Kaminer Y, Kahler CW, Hoeppner B, Yeterian J, Cristello JV, Timko C. A pilot randomized clinical trial testing integrated 12-Step facilitation (iTSF) treatment for adolescent substance use disorder. Addiction. 2017 Dec;112(12):2155-2166. doi: 10.1111/add.13920. Epub 2017 Aug 1.

  PMID: 28742932 BACKGROUND

• Kelly JF, Yeterian JD, Cristello JV, Kaminer Y, Kahler CW, Timko C. Developing and Testing Twelve-Step Facilitation for Adolescents with Substance Use Disorder: Manual Development and Preliminary Outcomes. Subst Abuse. 2016 Jun 13;10:55-64. doi: 10.4137/SART.S39635. eCollection 2016.

  PMID: 27429548 BACKGROUND

• Kelly JF, Urbanoski K. Youth recovery contexts: the incremental effects of 12-step attendance and involvement on adolescent outpatient outcomes. Alcohol Clin Exp Res. 2012 Jul;36(7):1219-29. doi: 10.1111/j.1530-0277.2011.01727.x. Epub 2012 Apr 17.

  PMID: 22509904 BACKGROUND

• Kelly JF, Urbanoski KA, Hoeppner BB, Slaymaker V. Facilitating comprehensive assessment of 12-step experiences: A Multidimensional Measure of Mutual-Help Activity. Alcohol Treat Q. 2011 Jan 1;29(3):181-203. doi: 10.1080/07347324.2011.586280.

  PMID: 22081741 BACKGROUND

• Kelly JF, Dow SJ, Yeterian JD, Myers M. How safe are adolescents at Alcoholics Anonymous and Narcotics Anonymous meetings? A prospective investigation with outpatient youth. J Subst Abuse Treat. 2011 Jun;40(4):419-25. doi: 10.1016/j.jsat.2011.01.004. Epub 2011 Feb 24.

  PMID: 21353446 BACKGROUND

• Kelly JF, Dow SJ, Yeterian JD, Kahler CW. Can 12-step group participation strengthen and extend the benefits of adolescent addiction treatment? A prospective analysis. Drug Alcohol Depend. 2010 Jul 1;110(1-2):117-25. doi: 10.1016/j.drugalcdep.2010.02.019. Epub 2010 Mar 24.

  PMID: 20338698 BACKGROUND

• Kelly JF, Myers MG, Rodolico J. What do adolescents exposed to Alcoholics Anonymous think about 12-step groups? Subst Abus. 2008;29(2):53-62. doi: 10.1080/08897070802093122.

  PMID: 19042324 BACKGROUND

• Kelly JF, Brown SA, Abrantes A, Kahler CW, Myers M. Social recovery model: an 8-year investigation of adolescent 12-step group involvement following inpatient treatment. Alcohol Clin Exp Res. 2008 Aug;32(8):1468-78. doi: 10.1111/j.1530-0277.2008.00712.x. Epub 2008 Jun 28.

  PMID: 18557829 BACKGROUND

• Dennis M, Godley SH, Diamond G, Tims FM, Babor T, Donaldson J, Liddle H, Titus JC, Kaminer Y, Webb C, Hamilton N, Funk R. The Cannabis Youth Treatment (CYT) Study: main findings from two randomized trials. J Subst Abuse Treat. 2004 Oct;27(3):197-213. doi: 10.1016/j.jsat.2003.09.005.

  PMID: 15501373 BACKGROUND

• Webb, C., Scudder, M., Kaminer, Y., & Kadden, R. M. (2002). The Motivational Enhancement Therapy and Cognitive Behavioral Therapy Supplement: 7 Sessions of Cognitive Behavioral Therapy for Adolescent Cannabis Users, Cannabis Youth Treatment (CYT) Series, Volume 2. DHHS Pub. No. (SMA) 07-3954. Rockville, MD: Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, 2002, reprinted 2003, 2004, and 2007.

  BACKGROUND

• Sampl, S., & Kadden, R. M. (2001). Motivational Enhancement Therapy and Cognitive Behavioral Therapy for Adolescent Cannabis Users: 5 Sessions, Cannabis Youth Treatment (CYT) Series, Volume. Rockville, MD: Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration. BKD384.

  BACKGROUND

• Kelly JF, Myers MG, Brown SA. A multivariate process model of adolescent 12-step attendance and substance use outcome following inpatient treatment. Psychol Addict Behav. 2000 Dec;14(4):376-89.

  PMID: 11130156 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

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Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• John F Kelly, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra W Abry, BA

CONTACT

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

Jenny B O'Connor, BA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Staff conducting assessments are blinded to participant condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Recovery Research Institute; Elizabeth R. Spallin Professor of Psychiatry

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: November 26, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: March 6, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Requests for data access will be fielded after publication of primary study aims.
• Access Criteria: The method of data sharing will be under the auspices of the Principal Investigators (PIs). That is, researchers interested in using the data generated by this study may contact the PIs to receive a copy of the data, which they will receive only after an executed data-sharing agreement is in place. Requests will be processed once the major findings pertaining to the aims have been published. Per NOA-AA-23-002, investigators will submit data to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Data Archive. The NIAAA Data Archive is housed within the larger National Institute of Mental Health (NIMH) Data Archive (NDA), a data repository for human subject research.

Locations

US (2)