Recruiting

Caregiver Involvement

Sponsor:

Indiana University

Code:

NCT06593652

Conditions

Alcohol Use

Adolescent

Mild Alcohol Use Disorder

Mild Substance Use Disorder

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Teen Intervene - Adolescent Only

Teen Intervene with Caregiver Session

Family Check Up

Study Details

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.

Conditions

Alcohol Use

Adolescent

Mild Alcohol Use Disorder

Mild Substance Use Disorder

Study ID

NCT06593652

Start date

Aug 19, 2025

Status verified date

Oct, 2025

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 12-17 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

Exclusion Criteria:

  • N/A

Study Design

Enrollment

615 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Teen Intervene - Adolescent Only

Only the youth will participate in the brief intervention, Teen Intervene. The youth will participate in manual-standardized Teen Intervene sessions.

experimental: Teen Intervene - Caregiver Involvement

The youth will participate in two Teen Intervene sessions. Additionally, the caregiver(s) will participate in a single, caregiver-only Teen Intervene session.

experimental: Teen Intervene - Online Caregiver Support Tool

Only 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 - Adolescent Only

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 with Caregiver Session

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

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.

Primary outcome measure

  • Timeline Follow-Back [ Time Frame: *0-at time of intervention, *3 months after time of intervention; *6 months after time of intervention; *12 months after time of intervention ]

Central Contacts and Locations

Central contacts

SPARC Research Team

(317) 274-7715sparc@iu.edu

Zachary Adams, PhD, HSPP

317-278-0591zwadams@iu.edu

Locations

IU Health/Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46112

Contacts

SPARC Research Team

(317) 274-7715sparc@iu.edu

Principal Investigator:

Zack Adams, PhD, HSPP

More Information

Sponsor

Indiana University

Last update posted

Jan 2, 2026

Last verified

Oct, 2025

Keywords

  • Brief Intervention
  • Teen Intervene
  • Caregiver Involvement
  • Alcohol Use
  • Substance Use

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-01-02.