Primary Connections for Youth and Families

Official title

Adolescent-Only SBI Versus Family-Based SBI in Primary Care for Adolescent Alcohol Use

Overview

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.

Interventions

• Behavioral Standard Screening
  All consented youth age 12-17 years complete a patient-facing, well-validated digital screening tool, the CRAFFT (Knight et al., 2003), which assesses number of days during the past year, and then the past 3 months, during which various formulations of AOD were used. If youth report 0 days of AOD use, the tool asks whether they have ridden in a car whose driver was intoxicated; if this response is negative, they are categorized Low Risk. If youth report \> 0 days of AOD use, the tool asks five a
• Behavioral Standard Psychoeducation
  In the wait area, youth receive a tablet-delivered brief digital AOD education tutorial that includes advice to abstain from or reduce AOD use. The tutorial focuses on adolescent AOD prevalence rates and related behavioral symptoms; AOD use neurobiology and its relation to adolescent health; and common AOD impacts on developmental milestones (see Meredith et al., 2021). Psychoeducation for AOD has shown positive effects as both a universal and selective prevention strategy (Bröning et al., 2021;
• Behavioral Standard Brief Negotiated Interview (BNI)
  In primary care (PC) office, youth and providers together complete a tablet-supported brief negotiated interview (BNI; see Beaton et al., 2016). The BNI is informed by AOD use data gathered during youth screening (O'Grady et al., 2015). The BNI focuses on (a) education about AOD disorders, including youth and family factors that impact AOD use; (b) user-tailored feedback comparing the given youth's AOD use and related problems to national norms, along with information on neurobiological effects
• Behavioral Standard Referral to Treatment (RT)
  In primary care (PC) offices providers and youth discuss the value of attending counseling services to address AOD-related problems (Cucciare et al., 2015); counseling referral links that the PC site curates with local services; and the value of youth talking directly with caregivers about their AOD involvement as a first step toward support-seeking and behavior change (Gayes \& Steele, 2014). Providers directly recommend AOD counseling and facilitate a first appointment for youth who agree.
• Behavioral Family Screening
  Screening procedures incorporate procedures for youth described for Standard Screening. They also incorporate two sources of caregiver-report data. First is an estimate of youth AOD use based on the Screening 2 Brief Intervention tool (Levy et al., 2016). Second is a 9-item checklist of youth mental health (MH) problems (Achenbach \& Rescorla, 2001). If both youth and caregiver report no AOD use or clinical-level MH problem, the family is categorized Low Risk. Otherwise, screen data are combined
• Behavioral Family Psychoeducation
  Youth proceed as indicated in the SBIRT-A-Standard condition based on youth screen data. In the wait area, caregivers receive a tablet-delivered parenting tutorial that covers two AOD risk domains: education about adolescent AOD including prevalence rates, related behavior problems, neurobiological and health effects, and impacts on developmental milestones; and education and video modeling about parenting strategies that reduce or moderate AOD risk, including positive communication, fair and co
• Behavioral Family Brief Negotiated Interview (BNI)
  Youth proceed as indicated in the SBIRT-A-Standard condition based on youth screen data. In primary care (PC) offices, caregivers and providers together complete a tablet-supported parenting BNI informed by data from the caregiver screen only that parallels the youth BNI (e.g., AOD education, developmental risks) and also includes motivation, modeling, and goal-setting on positive parenting (e.g., non-judgmental conversations; see above) and effective parent-youth communication about AOD use (Ca
• Behavioral Family Facilitated Conversation (FC) & Referral to Treatment (RT)
  In PC offices, providers meet separately with youth and caregivers to discuss the value of talking directly with the other family member about AOD risk while practicing positive communication strategies. Whenever both youth and caregiver agree to talk together, providers convene a brief facilitated conversation about AOD risk. In this conversation providers (a) emphasize that a positive youth-caregiver relationship is the strongest protective factor for youth development and (b) follow guideline

Primary outcome measures

• 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]
• Change in Youth Risk Index (ALEXSA; Ridenour et al., 2009) [Time frame: Initial and 3, 6, 9, and 12 months follow-up]
• Change in Brief Problem Monitor (BPM; Achenbach & Rescorla, 2001) [Time frame: Initial and 3, 6, 9, and 12 months follow-up]
• 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]
• 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]
• 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]
• 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]

Secondary outcome measures (3)

• Car Relax Alone Forget Family Trouble (CRAFFT; Knight et al., 2003) [Time frame: Initial screening]
• Hooked on Nicotine Checklist (HONC; DiFranza et al., 2002) [Time frame: Initial screening]
• Caregiver Estimate of Youth Alcohol and Other Drug Use (Levy et al., 2016; Levy et al., 2021) [Time frame: Initial screening]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Screening

Study locations

United States · 1 center

• Columbia University Medical Center — New York

Publications

• Hogue A, Porter NP, Ozechowski TJ, Becker SJ, O'Grady MA, Bobek M, Cerniglia M, Ambrose K, MacLean A, Hadland SE, Cunningham H, Bagley SM, Sherritt L, O'Connell M, Shrier LA, Harris SK. Standard Versus Family-Based Screening, Brief Intervention, and Referral to Treatment for Adolescent Substance Use in Primary Care: Protocol for a Multisite Randomized Effectiveness Trial. JMIR Res Protoc. 2024 May PMID 38819923

Identifiers

NCT: NCT05964010 · AU-2022C1-26455

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗