Actively Recruiting

Phase Not Applicable
Age: 12Years - 17Years
All Genders
ID06593652

Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems

Led by Indiana University · Updated on 2026-01-02

615

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the role of caregiver involvement in brief interventions for adolescents with mild alcohol use disorder (AUD) in primary care settings. This study focuses on U.S. teens aged 12 to 17, where alcohol is the most commonly used substance but few receive needed interventions. The study aims to find out whether no caregiver involvement, a single live caregiver session, or an online self-paced parenting program best reduces alcohol use and improves other related outcomes such as substance use and psychosocial functioning. The study compares three intervention approaches using Teen Intervene (TI), a brief motivational interviewing and cognitive-behavioral therapy program designed for youth. One group receives only youth-focused TI sessions, the second group receives youth sessions plus a single live caregiver session, and the third group receives youth sessions with access to an online caregiver tool called Family Check-Up Online (FCU). Each intervention is delivered in primary care, with sessions lasting 45 to 60 minutes. Caregiver involvement varies to assess impact on treatment outcomes. Participants will attend multiple assessment points including baseline, 3, 6, and 12 months after the intervention. Researchers will measure alcohol use frequency and amount using the Timeline Follow-Back method, as well as other substance use, substance use disorder symptoms, and psychosocial functioning through surveys and interviews. The study also examines factors influencing response to treatment and implementation challenges. The total participation period spans one year with regular follow-up evaluations.

CONDITIONS

Brief Title

Evaluating Caregiver Involvement in Primary Care-Based Brief Interventions for Adolescent Alcohol Use Problems

Who Can Participate

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 12 and 17 years
  • Mild to moderate alcohol or other substance use based on primary care provider surveys or clinical indication
  • Fluent in English
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Two to three sessions lasting 45 to 60 minutes each

Participants receive the Teen Intervene brief intervention over two or three sessions, which include motivational interviewing and cognitive-behavioral therapy skills to reduce alcohol use. Depending on the group, caregivers may participate in a single session or receive access to an online parenting program, or there may be no caregiver involvement.

2 to 3 visits (in-person or online depending on caregiver involvement)

Follow-up

Duration - Up to 12 months after the intervention

Participants are followed after the intervention to monitor alcohol use, other substance use, psychosocial functioning, and engagement with services. Follow-up assessments occur to evaluate the effectiveness of the intervention over time.

Visits at 3 months, 6 months, and 12 months post-intervention

Trial Site Locations

Total: 1 location

1

IU Health/Indiana University School of Medicine

Indianapolis, Indiana, United States, 46112

Actively Recruiting

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Research Team

S

SPARC Research Team

Z

Zachary Adams, PhD, HSPP

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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