Technology Interventions for Youth Alcohol Use

Alcohol Drinking Clinical Trial

Official title:

Comparing Scalable Technology-Driven Brief Intervention Packages for Youth Alcohol Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05988931
• Other study ID #: HUM00232130
• Secondary ID: AU-2022C1-25631
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: September 2027

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: Meredith Kotov
• Email: mphilyaw[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3-, 6-, 9- and 12- months post baseline
Secondary	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.	3-, 6-, 9- and 12- months post baseline
Secondary	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.	3-, 6-, 9- and 12- months post baseline