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Adolescent Substance Use Prevention Intervention Research Study in Pediatric Primary Care

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04450966
Acronym
ASPIRE
Enrollment
169
Registered
2020-06-30
Start date
2023-03-10
Completion date
2026-05-13
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALComputer-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.

Sponsors

Boston Children's Hospital
Lead SponsorOTHER
American Academy of Pediatrics
CollaboratorOTHER
Children's Hospital of Philadelphia
CollaboratorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Any heavy episodic drinking day during past 3 months3 months follow-upDefined using the NIAAA Youth Guide age/gender-specific number of drinks.
Time to first day of heavy episodic drinking during 12 month follow-up period1-12 months follow-upDefined using the NIAAA Youth Guide age/gender- specific number of drinks.

Secondary

MeasureTime frameDescription
Any riding/driving risk3 months follow-upAny riding with a driver who had been using alcohol or driving after using alcohol in past 3 months

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSion K Harris, PhD

Boston Children's Hospital

PRINCIPAL_INVESTIGATORLydia A Shrier, MD, MPH

Boston Children's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026