Primary Connections for Youth and Families

Phase

N/A

Condition

Stimulant Use Disorder

Opioid Use Disorder

Treatment

Family Screening

Family Facilitated Conversation (FC) & Referral to Treatment (RT)

Standard Referral to Treatment (RT)

Clinical Study ID

NCT05964010

AU-2022C1-26455

Ages 12-17
All Genders
Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Youth aged 12-17 years with a primary caregiver (i.e., parental figure) also in attendance to primary care appointment
Youth and caregiver are fluent in English or Spanish
Youth and caregiver are capable of using audio-assisted informed consent procedures and independently operating a hand-held tablet device
Youth and caregiver are complete routine site AOD risk screening questions prompted during PC visit intake

Study Design

Family Screening

March 01, 2024

November 30, 2027

Study Description

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.

Connect with a study center

Columbia University Medical Center
New York, New York 10013
United States
Active - Recruiting

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