- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05988931
Technology Interventions for Youth Alcohol Use
October 13, 2025 updated by: Maureen A Walton, University of Michigan
Comparing Scalable Technology-Driven Brief Intervention Packages for Youth Alcohol Use
The purpose of this study is to evaluate the effects of two programs to prevent/reduce alcohol misuse among youth primary care patients.
Depending on their study condition, youth will receive a brief web-based computer program or the web program + 8 weeks of supportive text messages.
Parents/caregivers of youth are encouraged to use a freely available app to guide conversations with their child about drinking.
This study will have significant impact by evaluating response to these scalable interventions which can be deployed widely in clinical care settings.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
1400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Meredith Kotov
- Phone Number: (734) 787-2059
- Email: mphilyaw@med.umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Contact:
- Meredith Kotov
-
Principal Investigator:
- Maureen Walton, PhD
-
Principal Investigator:
- Erin Bonar, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patients age 12-19 within the Michigan Medicine health system who had a visit within the past 2 years; and
- past 12-month alcohol use; and
- patient has a phone that can receive text messages
Exclusion Criteria:
- patients who do not understand English; or
- patients deemed unable to provide informed consent due to conditions that preclude understanding of assessment or intervention content; or
- parent/guardian consent is not obtained; or
- another child in household already enrolled in the study; or
- ongoing participation in another behavioral health research study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Web Program + App
Brief intervention web program (rooted in Motivational Interviewing) recommended at enrollment with parent/caregiver recommended to download and use app (with strategies to talk to youth about drinking prevention).
|
Youth receive a brief interactive web program made available online to prevent alcohol misuse.
The parent/caregiver app addresses monitoring and skill building for parents to communicate with the child about preventing underage drinking and drug use.
|
|
Active Comparator: Web Program + App + Text Messages
Brief intervention web program (rooted in Motivational Interviewing) recommended at enrollment with parent/caregiver recommended to download and use app (with strategies to talk to youth about drinking prevention) plus youth receive 8 weeks of text messages.
|
Youth receive a brief interactive web program made available online to prevent alcohol misuse.
This is followed by 8 weeks of supportive text messages.
The parent/caregiver app addresses monitoring and skill building for parents to communicate with the child about preventing underage drinking and drug use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Alcohol Consumption
Time Frame: 3-, 6-, 9- and 12- months post baseline
|
Alcohol consumption will be measured using total score on the 3-item Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) which includes typical quantity and frequency, and frequency of binge drinking (# of drinks modified by age based on the NIAAA Youth Guide).
Higher score indicates worse outcomes.
|
3-, 6-, 9- and 12- months post baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Alcohol Related Consequences
Time Frame: 3-, 6-, 9- and 12- months post baseline
|
Alcohol related consequences will be measured using total score on the brief 18-item version of the Rutgers Alcohol Problem Index (RAPI).
Higher score indicates worse outcomes.
|
3-, 6-, 9- and 12- months post baseline
|
|
Change in Other Drug Use
Time Frame: 3-, 6-, 9- and 12- months post baseline
|
Other drug use will be measured using scores derived from National Survey on Drug Use and Health (NSDUH) survey items for illicit (e.g., cannabis, cocaine, heroin) and prescription (i.e., in any way a doctor did not direct you to use; stimulants, sedatives, and opioids) drugs misuse.
Higher scores indicate worse outcomes.
|
3-, 6-, 9- and 12- months post baseline
|
|
Change in Other Drug Use Consequences
Time Frame: 3-, 6-, 9- and 12- months post baseline
|
Other drug use consequences will be measured using total score on an 18-item version of the drug-focused RAPI.
Higher score indicates worse outcomes.
|
3-, 6-, 9- and 12- months post baseline
|
|
Change in Depression Symptoms
Time Frame: 3-, 6-, 9- and 12-month post baseline
|
Depressive symptoms will be measured using the Patient Health Questionnaire-2 (PHQ-2).
Higher scores indicate worse outcomes, with a score of ≥ 3 indicating a positive depression screen.
|
3-, 6-, 9- and 12-month post baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Erin Bonar, PhD, University of Michigan
- Principal Investigator: Maureen Walton, MPH, PhD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 25, 2023
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
August 4, 2023
First Submitted That Met QC Criteria
August 4, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Estimated)
October 15, 2025
Last Update Submitted That Met QC Criteria
October 13, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00232130
- AU-2022C1-25631 (Other Identifier: Patient-Centered Outcomes Research Institute (PCORI))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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