Adolescent Substance Use Prevention Intervention Research Study in Pediatric Primary Care

Heavy Drinking Clinical Trial

— ASPIRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04450966
• Other study ID #: NIAAA_1R01AA027253-01A1
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: February 2024
• Source: Boston Children's Hospital
• Contact: Lydia A Shrier, MD, MPH
• Phone: 617-355-5133
• Email: lydia.shrier[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 406
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Driving Under the Influence
• Heavy Drinking
• Riding With Driver Under the Influence

Intervention

Behavioral:
• Computer-facilitated Screening and Brief Intervention
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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	American Academy of Pediatrics	Itasca	Illinois
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Boston Children's Hospital	American Academy of Pediatrics, Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Alcohol-related problems or negative consequences experienced since post-visit survey	Score on scale	6 months follow-up
Other	Alcohol-related problems or negative consequences experienced since post-visit survey	Score on scale	12 months follow-up
Other	Past 3 months alcohol use days	Number of days of any alcohol use in past 3 months	3 months follow-up
Other	Past 3 months alcohol use days	Number of days of any alcohol use in past 3 months	6 months follow-up
Other	Past 3 months alcohol use days	Number of days of any alcohol use in past 3 months	9 months follow-up
Other	Past 3 months alcohol use days	Number of days of any alcohol use in past 3 months	12 months follow-up
Other	Past 3 months heavy episodic drinking days	Number of days of heavy episodic drinking in past 3 months	3 months follow-up
Other	Past 3 months heavy episodic drinking days	Number of days of heavy episodic drinking in past 3 months	6 months follow-up
Other	Past 3 months heavy episodic drinking days	Number of days of heavy episodic drinking in past 3 months	9 months follow-up
Other	Past 3 months heavy episodic drinking days	Number of days of heavy episodic drinking in past 3 months	12 months follow-up
Other	Perceived risk of harm	Percent report perceiving moderate/great risk of harm from regular heavy episodic drinking	3 months follow-up
Other	Perceived risk of harm	Percent report perceiving moderate/great risk of harm from regular heavy episodic drinking	6 months follow-up
Other	Perceived risk of harm	Percent report perceiving moderate/great risk of harm from regular heavy episodic drinking	12 months follow-up
Other	Drinking refusal self-efficacy	Score on Drinking Refusal Self-Efficacy measure	3 months follow-up
Other	Drinking refusal self-efficacy	Score on Drinking Refusal Self-Efficacy measure	6 months follow-up
Other	Drinking refusal self-efficacy	Score on Drinking Refusal Self-Efficacy measure	12 months follow-up
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Time to first day of heavy episodic drinking during 12 month follow-up period	De?ned using the NIAAA Youth Guide age/gender- speci?c number of drinks.	1-12 months follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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