Alcohol Use Disorder, Cannabis Use Disorder
Conditions
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.
Interventions
BEHAVIORALInTEGRA
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
BEHAVIORALMET/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
Sponsors
Massachusetts General Hospital
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Staff conducting assessments are blinded to participant condition.
Eligibility
Sex/Gender
ALL
Age
14 Years to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Days Abstinent (PDA) | During treatment and up to 12 months following enrollment | 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. |
| Substance use related consequences | During treatment and up to 12 months following enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychiatric symptom severity | During treatment and up to 12 months following enrollment. | 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. |
Countries
United States
Contacts
CONTACTAlexandra W Abry, BA
CONTACTJenny B O'Connor, BA
PRINCIPAL_INVESTIGATORJohn F Kelly, PhD
Massachusetts General Hospital
Outcome results
None listed