Technology Interventions for Youth Alcohol Use

Sponsor
University of Michigan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05988931
Collaborator
Patient-Centered Outcomes Research Institute (Other)
1,400
1
2
47
29.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Web Program + App
  • Behavioral: Web Program + App + Text Messages
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Comparing Scalable Technology-Driven Brief Intervention Packages for Youth Alcohol Use
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2027
Anticipated Study Completion Date :
Sep 1, 2027

Arms and Interventions

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).

Behavioral: Web Program + App
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.

Behavioral: Web Program + App + 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.

Outcome Measures

Primary Outcome Measures

  1. Change in Alcohol Consumption [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.

Secondary Outcome Measures

  1. Change in Alcohol Related Consequences [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.

  2. Change in Other Drug Use [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. Change in Other Drug Use Consequences [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients age 12-17 within the Michigan medicine pediatric care system who had an appointment date 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan
  • Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Maureen Walton, MPH, PhD, University of Michigan
  • Principal Investigator: Erin Bonar, PhD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maureen A Walton, Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier:
NCT05988931
Other Study ID Numbers:
  • HUM00232130
  • AU-2022C1-25631
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023