Clinical trial NCT06395467: Integrated Treatment for Enhancing Growth in Recovery During Adolescence
Official title: Integrated Treatment for Enhancing Growth in Recovery During Adolescence (InTEGRA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Cannabis Use Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-05-02
Enrollment: 294
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Days Abstinent (PDA)
timeFrame: During treatment and up to 12 months following enrollment
measure: Substance use related consequences
timeFrame: During treatment and up to 12 months following enrollment
Secondary outcomes:
measure: Psychiatric symptom severity
timeFrame: During treatment and up to 12 months following enrollment.
Other outcomes:
measure: Percent days attending 12-step meetings
timeFrame: During treatment and up to 12 months following enrollment.
Locations:
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
city: Boston
country: United States
facility: MGH Department of Psychiatry
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: John F Kelly, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.