Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems
1 other identifier
interventional
615
1 country
1
Brief Summary
Intervention for mild severity alcohol use among U.S. teens is crucial, as alcohol is the most commonly used substance in this age group, yet few receive the necessary interventions. Primary care, where over 90% of youth regularly visit, is an ideal setting for identifying and addressing mild alcohol use disorder (AUD) through brief interventions like motivational interviewing (MI) and cognitive-behavioral therapy (CBT). However, for teens with mild AUD, a single brief session may not be sufficient, raising questions about the role of caregiver involvement. This study seeks to determine the most effective level of caregiver involvement-no involvement, a single live session, or an online self-paced program-in reducing alcohol use among adolescents with mild AUD in primary care settings. The study also explores the impact of these interventions on other outcomes such as substance use and psychosocial functioning, as well as the factors influencing treatment response. The results will guide the selection and implementation of effective, scalable interventions in primary care to address youth alcohol use disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
August 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
January 2, 2026
October 1, 2025
3 years
August 28, 2024
December 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Timeline Follow-Back
30 items that assess daily alcohol usage over the past month will be administered to all participants. Participants will be queried about number of standard drinks consumed each day.
*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
Secondary Outcomes (4)
Timeline Follow-Back
*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
DAST-A
*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
SUD Services Engagement
*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
PROMIS Surveys
*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
Other Outcomes (3)
Client Satisfaction Questionnaire
*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
Communities That Care Survey Family Factors
*0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention
Acceptability, Feasibility, and Appropriateness of Intervention Measure
once a year
Study Arms (3)
Teen Intervene - Adolescent Only
ACTIVE COMPARATOROnly the youth will participate in the brief intervention, Teen Intervene. The youth will participate in manual-standardized Teen Intervene sessions.
Teen Intervene - Caregiver Involvement
EXPERIMENTALThe youth will participate in two Teen Intervene sessions. Additionally, the caregiver(s) will participate in a single, caregiver-only Teen Intervene session.
Teen Intervene - Online Caregiver Support Tool
EXPERIMENTALOnly the youth will participate in the brief intervention, Teen Intervene. The youth will participate in two Teen Intervene sessions. Caregiver(s) will be provided with an online tool (Family Checkup Online) that addresses parenting strategies to support their youth.
Interventions
Teen Intervene (TI) is delivered over two or three, 45- to 60-minute sessions (2 teen sessions +/- 1 caregiver session) to reduce youth substance use, increase motivation for abstinence, and promote use of existing coping strategies. TI is an adolescent-appropriate adaptation of motivational enhancement therapy (MET), and includes a discussion of readiness to change, goal setting, personal feedback, a functional analysis of substance use, and a review of coping skills.
Teen Intervene (TI) is delivered over two or three, 45- to 60-minute sessions (2 teen sessions +/- 1 caregiver session) to reduce youth substance use, increase motivation for abstinence, and promote use of existing coping strategies. TI is an adolescent-appropriate adaptation of motivational enhancement therapy (MET), and includes a discussion of readiness to change, goal setting, personal feedback, a functional analysis of substance use, and a review of coping skills. In this condition, the caregiver session will address caregiver expectations around youth substance use and strategies for promoting positive youth behavior change including reduced substance use.
Family Check-Up Online (FCU-O) is a self-paced, parent-driven, fully HIPAA compliant online version of the Family Check-Up (FCU), a brief intervention that integrates assessment, motivation-enhancement, and skill building to help parents effectively manage behavior and build positive relationships with their children aged 2-17 in order to reduce emotional and behavioral problems among youth.
Eligibility Criteria
You may qualify if:
- years old;
- Mild to moderate severity for alcohol use (based on standardized surveys from their primary care provider or clinical indication) or other substance use
- English language fluency
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (1)
IU Health/Indiana University School of Medicine
Indianapolis, Indiana, 46112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zachary Adams, PhD, HSPP
Indiana University
- PRINCIPAL INVESTIGATOR
Tamika Zapolski, PhD, HSPP
Indiana University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The data analysts will be masked to intervention condition.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 28, 2024
First Posted
September 19, 2024
Study Start
August 19, 2025
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
January 2, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share
Though the researchers are not required to provide information about plans to share individual participant data (IPD), we plan to withhold individual participant data from sharing. This decision aligns with university policy and the terms outlined in our participants\' consent forms, which stipulate that patient information will not be shared publicly.