CompletedNot Applicable

Adolescent Substance Use Prevention Intervention Research Study in Pediatric Primary Care

United States169 participantsStarted 2023-03-10

Plain-language 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.

Who can participate

Age range

14 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Any heavy episodic drinking day during past 3 months

Timeframe: 3 months follow-up

Any heavy episodic drinking day during past 3 months

Timeframe: 6 months follow-up

Any heavy episodic drinking day during past 3 months

Timeframe: 9 months follow-up

Any heavy episodic drinking day during past 3 months

Timeframe: 12 months follow-up

Time to first day of heavy episodic drinking during 12 month follow-up period

Timeframe: 1-12 months follow-up

Trial details

NCT IDNCT04450966

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-25

View on ClinicalTrials.gov More Heavy Drinking trials

Plain-language summary

Who can participate

Age range

14 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.