NCT05988931

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Oct 2023Sep 2027

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 25, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

3.9 years

First QC Date

August 4, 2023

Last Update Submit

October 13, 2025

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (1)

  • Change in Alcohol Consumption

    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 Outcomes (4)

  • Change in Alcohol Related Consequences

    3-, 6-, 9- and 12- months post baseline

  • Change in Other Drug Use

    3-, 6-, 9- and 12- months post baseline

  • Change in Other Drug Use Consequences

    3-, 6-, 9- and 12- months post baseline

  • Change in Depression Symptoms

    3-, 6-, 9- and 12-month post baseline

Study Arms (2)

Web Program + App

ACTIVE COMPARATOR

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).

Behavioral: Web Program + App

Web Program + App + Text Messages

ACTIVE COMPARATOR

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.

Behavioral: Web Program + App + Text Messages

Interventions

Web Program + AppBEHAVIORAL

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.

Web Program + App
Web Program + App + Text MessagesBEHAVIORAL

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.

Web Program + App + Text Messages

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Maureen Walton, MPH, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Erin Bonar, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meredith Kotov

CONTACT

(734) 787-2059mphilyaw@med.umich.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

October 25, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

October 15, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)