Back to resultsTechnology Interventions for Youth Alcohol Use
Primary Purpose
Alcohol Drinking
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web Program + App
Web Program + App + Text Messages
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Drinking
Eligibility Criteria
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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Web Program + App
Web Program + App + Text Messages
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Alcohol Related Consequences
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.
Change in Other Drug Use
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.
Change in Other Drug Use Consequences
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.
Full Information
NCT ID
NCT05988931
First Posted
August 4, 2023
Last Updated
August 4, 2023
Sponsor
University of Michigan
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05988931
Brief Title
Technology Interventions for Youth Alcohol Use
Official Title
Comparing Scalable Technology-Driven Brief Intervention Packages for Youth Alcohol Use
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
September 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Web Program + App
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Web Program + App + Text Messages
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Web Program + App
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Web Program + App + Text Messages
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Alcohol Consumption
Description
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.
Time Frame
3-, 6-, 9- and 12- months post baseline
Secondary Outcome Measure Information:
Title
Change in Alcohol Related Consequences
Description
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.
Time Frame
3-, 6-, 9- and 12- months post baseline
Title
Change in Other Drug Use
Description
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.
Time Frame
3-, 6-, 9- and 12- months post baseline
Title
Change in Other Drug Use Consequences
Description
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.
Time Frame
3-, 6-, 9- and 12- months post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany Wheeler
Email
tiffdw@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Meredith Kotov
Email
mphilyaw@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen Walton, MPH, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erin Bonar, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Wheeler
First Name & Middle Initial & Last Name & Degree
Meredith Kotov
First Name & Middle Initial & Last Name & Degree
Maureen Walton, PhD
First Name & Middle Initial & Last Name & Degree
Erin Bonar, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Technology Interventions for Youth Alcohol Use
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