Adolescent-Only SBI Versus Family-Based SBI in Primary Care for Adolescent Alcohol Use
Overview
- Phase
- Not Applicable
- Intervention
- Standard Screening
- Conditions
- Substance Use
- Sponsor
- The National Center on Addiction and Substance Abuse at Columbia University
- Enrollment
- 2300
- Locations
- 1
- Primary Endpoint
- Change in Assessment of Liability and Exposure to Substance use and Antisocial Behavior (ALEXSA; Ridenour et al., 2009)
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
Aaron Hogue
Director, Family and Adolescent Clinical Technology & Science (FACTS)
Partnership to End Addiction
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
Exclusion Criteria
- Not provided
Arms & Interventions
SBIRT-A-Standard
Standard adolescent-only approach to screening, brief intervention, and referral to treatment for adolescent substance use.
Intervention: Standard Screening
SBIRT-A-Standard
Standard adolescent-only approach to screening, brief intervention, and referral to treatment for adolescent substance use.
Intervention: Standard Psychoeducation
SBIRT-A-Standard
Standard adolescent-only approach to screening, brief intervention, and referral to treatment for adolescent substance use.
Intervention: Standard Brief Negotiated Interview (BNI)
SBIRT-A-Standard
Standard adolescent-only approach to screening, brief intervention, and referral to treatment for adolescent substance use.
Intervention: Standard Referral to Treatment (RT)
SBIRT-A-Family
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.
Intervention: Family Screening
SBIRT-A-Family
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.
Intervention: Family Psychoeducation
SBIRT-A-Family
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.
Intervention: Family Brief Negotiated Interview (BNI)
SBIRT-A-Family
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.
Intervention: Family Facilitated Conversation (FC) & Referral to Treatment (RT)
Outcomes
Primary Outcomes
Change in Assessment of Liability and Exposure to Substance use and Antisocial Behavior (ALEXSA; Ridenour et al., 2009)
Time Frame: Initial and 3, 6, 9, and 12 months follow-up
Youth report audio-assisted self-interview that measures frequency of alcohol and other drug use. This study will use 6 items. The first three items assess whether youth have ever used alcohol, tobacco, and marijuana (yes/no). If use of a substance is reported, a follow-up question is presented regarding frequency of use e.g., "How often do you \[use tobacco/drink alcohol/ use marijuana\] right now?" with response options of 0 = never to 5 = every day for each substance. For each substance, scores range from 0 to 5 with higher scores indicate more frequent use.
Change in Youth Risk Index (ALEXSA; Ridenour et al., 2009)
Time Frame: Initial and 3, 6, 9, and 12 months follow-up
Youth and caregiver report measure assessing risk factors associated with youth alcohol and other drug use. The YRI contains 23 items from the ALEXSA measuring risk factors associated with youth substance use including anger coping, impulsivity, distractibility, disinhibition, peer conduct problems, and susceptibility to peer pressure. 17 items are rated on a 4-point likert scale from 0 to 3 and 6 items are measured on a 6-point scale from 0 to 5+. Total score ranges from 0 to 81 with higher scores indicating more risk factors.
Change in Parent-Teen Alcohol and Other Drug Use Communication Quality (Spijkerman et al., 2008)
Time Frame: Initial and 3, 6, 9, and 12 months follow-up
6-item youth and caregiver report measure assessing quality of communication about key alcohol and other drug use issues. Items are rated on a 5-point scale from 0 = never to 4 = very often. Total score ranges from 0 to 20 with higher scores indicating greater communication quality.
Change in Brief Problem Monitor (BPM; Achenbach & Rescorla, 2001)
Time Frame: Initial and 3, 6, 9, and 12 months follow-up
A 19-item youth and caregiver report component of the well-validated Achenbach youth behavior problem assessment system that yields normed scores with clinical cut levels for three problem domains: internalizing (anxiety, depression, somatic complaints), externalizing (aggression, conduct problems), inattention/impulsivity. Items are rated on a 3-point scale from 0 = never to 2 = often. Total score ranges from 0 to 38 with higher scores representing more problems.
Change in Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0; Children's Hospital and Health Center, San Diego, CA)
Time Frame: Initial and 3, 6, 9, and 12 months follow-up
Youth and caregiver report measure assessing youth functioning in different domains. This study will use the Social and School scales. Each scale has 5 items and items are scored on a 5-point scale from 0 = never a problem to 4 = almost always a problem. Some items are reversed scored such that each scale ranges from 0 to 20 with higher scores indicating better quality of life.
Change in Services Assessment for Children and Adolescents (SACA; Stiffman et al., 2000)
Time Frame: Initial and 3, 6, 9, and 12 months follow-up
Caregiver report measure assessing youth's past and current use of inpatient, outpatient, and school-based behavioral health services. Items are dichotomous (yes/no) and the scale ranges from 0 (no services) to 3 (3 types of services) for past and current use such that higher numbers indicate more services.
Change in Parent-Teen Alcohol and Other Drug Use Communication Frequency (Koning et al., 2014)
Time Frame: Initial and 3, 6, 9, and 12 months follow-up
6-item youth and caregiver report measure assessing frequency of communication about key alcohol and other drug use issues. Items are rated on a 5-point scale from 0 = never to 4 = very often. Total score ranges from 0 to 20 with higher scores indicating greater communication frequency.
Secondary Outcomes
- Car Relax Alone Forget Family Trouble (CRAFFT; Knight et al., 2003)(Initial screening)
- Hooked on Nicotine Checklist (HONC; DiFranza et al., 2002)(Initial screening)
- Caregiver Estimate of Youth Alcohol and Other Drug Use (Levy et al., 2016; Levy et al., 2021)(Initial screening)