Technology Interventions for Youth Alcohol Use

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Drinking

Intervention / Treatment
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* Behavioral: Web Program + App
* Behavioral: Web Program + App + Text Messages


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Web Program + App<br>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<br>* 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.<br>|
| Active Comparator: Web Program + App + Text Messages<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |