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Adolescent-Only SBI Versus Family-Based SBI in Primary Care for Adolescent Alcohol Use
The goal of this clinical trial is to compare a standard adolescent-only approach to substance use screening, brief intervention, and referral to treatment to a in primary care settings. Primary outcomes (AOD use, co-occurring behavior problems, parent-youth communication about AOD use) and secondary outcomes (adolescent quality of life, therapy attendance) are assessed at screen/initial and 3, 6, 9, and 12 months follow-up.
This randomized effectiveness trial compares a standard adolescent-only approach (SBIRT-A-Standard) versus a family-based approach (SBIRT-A-Family) in which caregivers are systematically included in screening, intervention, and referral activities. The study includes N = 2,300 adolescents (age 12 - 17) and their caregivers attending one of three hospital-affiliated pediatric settings serving diverse patients in major urban areas. Study recruitment, initial screening, randomization, and all SBIRT-A activities occur during a single pediatric visit. SBIRT-A procedures are delivered primarily in digital format on hand-held tablets using both patient-facing and provider-facing programming. Primary outcomes (AOD use, co-occurring behavior problems, parent-youth communication about AOD use) and secondary outcomes (adolescent quality of life, therapy attendance) are assessed at screen/initial and 3, 6, 9, and 12 months follow-up. The study is well powered to conduct all planned main and moderator (age, sex, race/ethnicity, youth AOD risk status) analyses.
Age
12 - 17 years
Sex
ALL
Healthy Volunteers
Yes
Columbia University Medical Center
New York, New York, United States
Start Date
March 1, 2024
Primary Completion Date
November 1, 2028
Completion Date
December 1, 2029
Last Updated
March 18, 2026
2,300
ESTIMATED participants
Standard Screening
BEHAVIORAL
Standard Psychoeducation
BEHAVIORAL
Standard Brief Negotiated Interview (BNI)
BEHAVIORAL
Standard Referral to Treatment (RT)
BEHAVIORAL
Family Screening
BEHAVIORAL
Family Psychoeducation
BEHAVIORAL
Family Brief Negotiated Interview (BNI)
BEHAVIORAL
Family Facilitated Conversation (FC) & Referral to Treatment (RT)
BEHAVIORAL
Lead Sponsor
The National Center on Addiction and Substance Abuse at Columbia University
Collaborators
NCT04197921
NCT07199335
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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