Adolescent Substance Use Prevention Intervention Research Study in Pediatric Primary Care

Study Overview
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Brief Summary
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Our goal is to conduct a large multi-site randomized controlled trial (RCT) of a promising computer-facilitated Screening and clinician Brief Intervention (cSBI) system designed for delivery by pediatric primary care clinicians and aimed at reducing unhealthy alcohol use and related riding/driving safety risk among adolescent patients. Our setting will be the American Academy of Pediatrics' (AAP) Pediatric Research in Office Settings (PROS) national primary care research network, with >600 U.S. primary care practices having participated in recent studies. This trial addresses the evidence gap identified in the latest U.S. Preventive Services Task Force review of alcohol screening and brief counseling interventions among adolescents, and, if shown effective, the cSBI system could be widely disseminated via AAP's existing education, teaching, and advocacy platforms to its 67,000 pediatrician members, thereby greatly increasing the potential for population-level impact of alcohol screening and brief intervention for U.S. adolescents.

Detailed Description
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Alcohol use disorders frequently have a pediatric origin. Pediatric primary care offices, where the majority of adolescents receive health care, are a promising venue for early identification and intervention through universal screening and brief counseling. However, while the U.S. Preventive Services Task Force recommends primary care-based alcohol screening and brief intervention for adults, it found insufficient evidence to recommend it for adolescents. The goal of the proposed study is to address this evidence gap by testing the effectiveness of a promising computer-facilitated Screening and Brief Intervention (cSBI) system for delivery by pediatric primary care clinicians to adolescents at well-visits. This cluster-randomized controlled trial will be conducted in the American Academy of Pediatrics' (AAP) Pediatric Research in Office Settings (PROS) national primary care practice-based research network. PROS has demonstrated success in >30 years of practice-based research, with >600 practices participating in recent studies. Drawing on more than 15 years of our prior research on adolescent alcohol screening and brief counseling in primary care offices, the cSBI system was developed to provide a time-efficient and feasible way for pediatric practices to improve both the frequency and quality of alcohol screening and counseling. cSBI includes: 1) computer self-administered screening that adolescents complete prior to seeing their clinician, 2) 10 interactive psychoeducational pages for the adolescent on substance use health risks, 3) a Clinician Report Form with screen results and prompts that clinicians use to provide motivational interviewing-based individualized counseling, and 4) clinician training materials and protocol. In a New England-based pilot study, we found that, compared to usual care (UC), the cSBI approach: 1) increased patient receipt of alcohol-related counseling during well-visits; 2) improved patients' ratings of the quality of their clinician encounter; and 3) among those who reported past-year use at baseline (n=192), was associated with a 34% lower risk of a heavy episodic drinking episode during 12 months follow-up. cSBI also reduced risk of riding with an impaired driver, a major safety risk associated with alcohol, by 42% among those with prior riding risk. A larger RCT of this approach, which employs an adequately-powered sample and tests generalizability of effects beyond New England, is needed. We will randomize >30 pediatric primary care clinicians in  10 practices nationwide to deliver UC or cSBI (1:1) to their eligible and assenting 14- to 17-year-old patients arriving for well-visits. Our aims are to test cSBI's effect on heavy episodic drinking, and on riding with an impaired driver/driving while impaired, during 12 months follow-up among 1,300 adolescents screen-identified as at-risk. We hypothesize that, compared to adolescent patients receiving usual care, those receiving cSBI will have lower rates of reporting heavy episodic drinking and riding with an impaired driver/driving while impaired during the study follow-up period.

Official Title
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Computer-facilitated Screening and Brief Intervention (cSBI) in Pediatric Primary Care to Reduce Underage Drinking: a Large, Multi-site Randomized Trial

Conditions
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Heavy Drinking, Driving Under the Influence, Riding With Driver Under the Influence

Intervention / Treatment
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* Behavioral: Computer-facilitated Screening and Brief Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 14-17 Presenting for well-visit with participating clinician Reports any past 12 month alcohol use If no past-12-month alcohol use, reports riding with a driver under the influence in the past 12 months Has own cell phone and is willing to share cell phone number before their scheduled visit Completes required pre-visit activity/activities before well visit Exclusion Criteria: Youth in foster care Unable to read and communicate in English College students at time of recruitment Unable to complete follow-ups Currently receiving treatment from specialty clinician(s) for a substance use concern Deemed by their clinician to be inappropriate for study participation due to neurodevelopmental delays or medical/emotional concerns

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-site cluster-randomized parallel groups trial. >30 pediatric primary care clinicians will be recruited from  10 practices and will be allocated 1:1 to either deliver usual care or the cSBI intervention to their participating patients ages 14-17 years-old.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Clinicians randomized to this arm will not receive training in delivery of cSBI until study completion, and their participating patients will receive usual care. | |
| Experimental: Computer-facilitated screening and brief intervention<br>Clinicians randomized to this arm will receive training in delivery of cSBI and their participating patients will then receive the experimental intervention. | Behavioral: Computer-facilitated Screening and Brief Intervention<br>* cSBI includes: 1) computer self-administered screening that adolescents complete prior to seeing their clinician, immediately followed by 2) computer-delivered brief psychoeducation on the health risks of substance use to prime patients for the clinician encounter, and 3) a Clinician Report Form with screen results and prompts that clinicians use to provide motivational interviewing-based individualized counseling during the visit.<br>* Other names: cSBI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any heavy episodic drinking day during past 3 months | Defined using the NIAAA Youth Guide age/gender-specific number of drinks. | 3 months follow-up | 
| Any heavy episodic drinking day during past 3 months | Defined using the NIAAA Youth Guide age/gender-specific number of drinks. | 6 months follow-up | 
| Any heavy episodic drinking day during past 3 months | Defined using the NIAAA Youth Guide age/gender-specific number of drinks. | 9 months follow-up | 
| Any heavy episodic drinking day during past 3 months | Defined using the NIAAA Youth Guide age/gender-specific number of drinks. | 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any riding/driving risk | Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months | 3 months follow-up | 
| Any riding/driving risk | Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months | 6 months follow-up | 
| Any riding/driving risk | Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months | 9 months follow-up | 
| Any riding/driving risk | Any riding with a driver who had been using alcohol or driving after using alcohol in past 3 months | 12 months follow-up |