Primary Connections for Youth and Families (PCYF)

The National Center on Addiction and Substance Abuse at Columbia University

Status: Enrolling

Conditions: Substance Use

Treatments: Behavioral: Family Psychoeducation; Behavioral: Standard Psychoeducation; Behavioral: Standard Referral to Treatment (RT); Behavioral: Family Brief Negotiated Interview (BNI); Behavioral: Standard Brief Negotiated Interview (BNI); Behavioral: Family Facilitated Conversation (FC) & Referral to Treatment (RT); Behavioral: Standard Screening; Behavioral: Family Screening

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05964010

AU-2022C1-26455

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,300 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,300 participants in 2 patient groups

SBIRT-A-Standard

Active Comparator group

Description:

Standard adolescent-only approach to screening, brief intervention, and referral to treatment for adolescent substance use.

Treatment:

Behavioral: Standard Screening

Behavioral: Standard Referral to Treatment (RT)

Behavioral: Standard Psychoeducation

Behavioral: Standard Brief Negotiated Interview (BNI)

SBIRT-A-Family

Experimental group

Description:

Family-based approach to screening, brief intervention, and referral to treatment for adolescent substance use in which caregivers are systematically included in screening, intervention, and referral activities.

Treatment:

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

Behavioral: Family Psychoeducation

Behavioral: Family Brief Negotiated Interview (BNI)

Behavioral: Family Screening