12-Step Facilitation/MET/CBT (InTEGRA) vs. MET/CBT for Youth With Alcohol and Other Drug Use Disorder

Alcohol Use Disorder Clinical Trial

— InTEGRA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06395467
• Other study ID #: 2023P000727
• Secondary ID: R01AA030926
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Alexandra W Abry, BA
• Phone: 617-724-5259
• Email: aabry[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 294
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 21 Years

Eligibility

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 within 60-minute drive from the Boston (MGH) and Farmington (UConn) treatment sites

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Cannabis Use Disorder

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	MGH Department of Psychiatry	Boston	Massachusetts
United States	UConn Health	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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.

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.

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent days attending 12-step meetings	Percentage of days attending one or more 12-step mutual-help meetings derived from adapted version of TLFB as well as multidimensional mutual-help activity scale.	During treatment and up to 12 months following enrollment.
Primary	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
Primary	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	Psychiatric symptom severity	Measure of psychiatric symptoms as assessed by the Brief Symptom Inventory-18 (BSI-18), an 18-item measure with response options from 0 to 4 (minimum = 0 and maximum = 72 which are converted to gender normed T scores of M = 50 and SD = 10); higher scores correspond with more symptomatology.	During treatment and up to 12 months following enrollment.