Clinical trial NCT04450966: Adolescent Substance Use Prevention Intervention Research Study in Pediatric Primary Care
Official title: Computer-facilitated Screening and Brief Intervention (cSBI) in Pediatric Primary Care to Reduce Underage Drinking: a Large, Multi-site Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heavy Drinking
Driving Under the Influence
Riding with Driver Under the Influence
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: American Academy of Pediatrics
name: Children's Hospital of Philadelphia
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-06-30
Enrollment: 406
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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 adolescent patients' heavy episodic drinking, and on riding with an impaired driver/driving while impaired, during 12 months follow-up. 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.

Eligibility criteria: Inclusion Criteria:

* Ages 14-17
* Presenting for well-visit with participating clinician
* Reports any lifetime alcohol use
* If no lifetime 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
* 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

Primary outcomes:
measure: Any heavy episodic drinking day during past 3 months
timeFrame: 3 months follow-up
measure: Any heavy episodic drinking day during past 3 months
timeFrame: 6 months follow-up
measure: Any heavy episodic drinking day during past 3 months
timeFrame: 9 months follow-up
measure: Any heavy episodic drinking day during past 3 months
timeFrame: 12 months follow-up
measure: Time to first day of heavy episodic drinking during 12 month follow-up period
timeFrame: 1-12 months follow-up
Secondary outcomes:
measure: Any riding/driving risk
timeFrame: 3 months follow-up
measure: Any riding/driving risk
timeFrame: 6 months follow-up
measure: Any riding/driving risk
timeFrame: 9 months follow-up
measure: Any riding/driving risk
timeFrame: 12 months follow-up
Other outcomes:
measure: Alcohol-related problems or negative consequences experienced since post-visit survey
timeFrame: 6 months follow-up
measure: Alcohol-related problems or negative consequences experienced since post-visit survey
timeFrame: 12 months follow-up
measure: Past 3 months alcohol use days
timeFrame: 3 months follow-up
measure: Past 3 months alcohol use days
timeFrame: 6 months follow-up
measure: Past 3 months alcohol use days
timeFrame: 9 months follow-up
measure: Past 3 months alcohol use days
timeFrame: 12 months follow-up
measure: Past 3 months heavy episodic drinking days
timeFrame: 3 months follow-up
measure: Past 3 months heavy episodic drinking days
timeFrame: 6 months follow-up
measure: Past 3 months heavy episodic drinking days
timeFrame: 9 months follow-up
measure: Past 3 months heavy episodic drinking days
timeFrame: 12 months follow-up
measure: Perceived risk of harm
timeFrame: 3 months follow-up
measure: Perceived risk of harm
timeFrame: 6 months follow-up
measure: Perceived risk of harm
timeFrame: 12 months follow-up
measure: Drinking refusal self-efficacy
timeFrame: 3 months follow-up
measure: Drinking refusal self-efficacy
timeFrame: 6 months follow-up
measure: Drinking refusal self-efficacy
timeFrame: 12 months follow-up
Locations:
city: Itasca
country: United States
facility: American Academy of Pediatrics
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Boston Children's Hospital
name: Sion K Harris, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Lydia A Shrier, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: