Clinical trial NCT05964010: Primary Connections for Youth and Families
Official title: Adolescent-Only SBI Versus Family-Based SBI in Primary Care for Adolescent Alcohol Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use
Keywords: adolescent substance use
pediatric primary care
screening
brief intervention
referral to treatment
family-based
Lead sponsor: The National Center on Addiction and Substance Abuse at Columbia University
Sponsor class: OTHER
Collaborators: name: Abt Associates
name: Northwestern University Feinberg School of Medicine
name: UConn Health
name: Massachusetts General Hospital
name: Boston Medical Center
name: Boston Children's Hospital
name: Columbia University
name: Patient-Centered Outcomes Research Institute
First posted: 2023-07-27
Enrollment: 2300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Standard adolescent-only approach to screening, brief intervention, and referral to treatment for adolescent substance use (SBIRT-A-Standard) versus a family-based approach (SBIRT-A-Family) in which caregivers are systematically included in screening, intervention, and referral activities.
Primary purpose: SCREENING

Brief 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: 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

Primary outcomes:
measure: Change in Assessment of Liability and Exposure to Substance use and Antisocial Behavior (ALEXSA; Ridenour et al., 2009)
timeFrame: Initial and 3, 6, 9, and 12 months follow-up
measure: Change in Youth Risk Index (ALEXSA; Ridenour et al., 2009)
timeFrame: Initial and 3, 6, 9, and 12 months follow-up
measure: Change in Brief Problem Monitor (BPM; Achenbach & Rescorla, 2001)
timeFrame: Initial and 3, 6, 9, and 12 months follow-up
measure: Change in Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0; Children's Hospital and Health Center, San Diego, CA)
timeFrame: Initial and 3, 6, 9, and 12 months follow-up
measure: Change in Services Assessment for Children and Adolescents (SACA; Stiffman et al., 2000)
timeFrame: Initial and 3, 6, 9, and 12 months follow-up
measure: Change in Parent-Teen Alcohol and Other Drug Use Communication Frequency (Koning et al., 2014)
timeFrame: Initial and 3, 6, 9, and 12 months follow-up
measure: Change in Parent-Teen Alcohol and Other Drug Use Communication Quality (Spijkerman et al., 2008)
timeFrame: Initial and 3, 6, 9, and 12 months follow-up
Secondary outcomes:
measure: Car Relax Alone Forget Family Trouble (CRAFFT; Knight et al., 2003)
timeFrame: Initial screening
measure: Hooked on Nicotine Checklist (HONC; DiFranza et al., 2002)
timeFrame: Initial screening
measure: Caregiver Estimate of Youth Alcohol and Other Drug Use (Levy et al., 2016; Levy et al., 2021)
timeFrame: Initial screening
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Partnership to End Addiction
name: Aaron Hogue, PhD
role: PRINCIPAL_INVESTIGATOR
References: