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NCT05964010NARecruitingAccepts Healthy Volunteers

Primary Connections for Youth and Families

The National Center on Addiction and Substance Abuse at Columbia University

Start Date

3/1/2024

Completion Date

12/1/2029

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.

Detailed 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.

Eligibility Criteria

Age Range: 12 years to 17 years

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

Interventions

BEHAVIORAL

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)

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Conditions

Substance Use

Locations

Columbia University Medical Center

New York, New York 10013

United States