NCT06699251

Brief Summary

Brief motivational interviewing intervention to address alcohol use among diverse teens 12-17.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress27%
Apr 2025Feb 2029

First Submitted

Initial submission to the registry

November 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

April 28, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

November 15, 2024

Last Update Submit

March 4, 2026

Conditions

Outcome Measures

Primary Outcomes (12)

  • Alcohol - change in frequency of use

    We will assess both the number of times participants have used alcohol in the past three months (from none to 31 or more times) and the number of days in the past month participants report use of alcohol.

    Baseline to 3 months

  • Alcohol - change in frequency of use

    We will assess both the number of times participants have used alcohol in the past three months (from none to 31 or more times) and the number of days in the past month participants report use of alcohol.

    3 months to 6 months

  • Alcohol - change in frequency of use

    We will assess both the number of times participants have used alcohol in the past six months (from none to 31 or more times) and the number of days in the past month participants report use of alcohol.

    6 months to 12 months

  • Cannabis - change in frequency of use

    We will assess both the number of times participants have used cannabis in the past three months (from none to 31 or more times) and the number of days in the past month participants report use of cannabis.

    Baseline to 3 months

  • Cannabis - change in frequency of use

    We will assess both the number of times participants have used cannabis in the past three months (from none to 31 or more times) and the number of days in the past month participants report use of cannabis.

    3 months to 6 months

  • Cannabis - change in frequency of use

    We will assess both the number of times participants have used cannabis in the past six months (from none to 31 or more times) and the number of days in the past month participants report use of cannabis.

    6 months to 12 months

  • Alcohol - change in consequences of use

    Alcohol consequences (e.g., blacking out, regretted sexual situation) will be assessed with the Brief Young Adult Alcohol Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome).

    Baseline to 3 months

  • Alcohol - change in consequences of use

    Alcohol consequences (e.g., blacking out, regretted sexual situation) will be assessed with the Brief Young Adult Alcohol Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome).

    3 months to 6 months

  • Alcohol - change in consequences of use

    Alcohol consequences (e.g., blacking out, regretted sexual situation) will be assessed with the Brief Young Adult Alcohol Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome).

    6 months to 12 months

  • Cannabis - change in consequences of use

    Cannabis consequences (e.g., poor memory, too much time using) will be assessed with the Brief Marijuana Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome).

    Baseline to 3 months

  • Cannabis - change in consequences of use

    Cannabis consequences (e.g., poor memory, too much time using) will be assessed with the Brief Marijuana Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome).

    3 months to 6 months

  • Cannabis - change in consequences of use

    Cannabis consequences (e.g., poor memory, too much time using) will be assessed with the Brief Marijuana Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome).

    6 months to 12 months

Secondary Outcomes (15)

  • Alcohol - change in time spent around peers

    Baseline to 3 months

  • Alcohol - change in time spent around peers

    3 months to 6 months

  • Alcohol - change in time spent around peers

    6 months to 12 months

  • Cannabis - change in time spent around peers

    Baseline to 3 months

  • Cannabis - change in time spent around peers

    3 months to 6 months

  • +10 more secondary outcomes

Study Arms (2)

Enhanced Usual Care

ACTIVE COMPARATOR

When the online consent/assent form is completed, the teen will be sent a personalized link to complete their baseline survey. Upon survey completion, the teen will receive a link that has their electronic gift card payment, and the case manager will be notified that a particular ID has completed the survey. The case manager will be informed by study staff whether to schedule that ID for enhanced usual care (EUC) or the Chat intervention. If they are randomized as EUC, the informational brochure for the EUC will be handed to the teen during the visit or securely emailed to them. Whether the teen completes EUC or Chat, every teen will be followed by the RAND Survey Research Group to complete their paid follow-up web-based surveys based on timing of completion of their baseline survey.

Behavioral: Enhanced Usual Care

Chat Intervention

EXPERIMENTAL

When the online consent/assent form is completed, the teen will be sent a personalized link to complete their baseline survey. Upon survey completion, the teen will receive a link that has their electronic gift card payment, and the case manager will be notified that a particular ID has completed the survey. The case manager will be informed by study staff whether to schedule that ID for enhanced usual care (EUC) or the Chat Intervention. If they are randomized as Chat Intervention, Chat will take place either via a virtual or in-person visit. Whether the teen completes EUC or Chat, every teen will be followed by the RAND Survey Research Group to complete their paid follow-up web-based surveys based on timing of completion of their baseline survey.

Behavioral: Chat

Interventions

ChatBEHAVIORAL

Chat is a brief motivational interviewing intervention for partner clinic participants with an alcohol or cannabis use condition.

Chat Intervention

An informational brochure will be give to partner clinic participants with an alcohol or cannabis use condition.

Enhanced Usual Care

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • receive health care at one of two participating health systems
  • aged 12-17
  • screen positive for being at risk for alcohol or cannabis use using the CRAFFT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AltaMed Health Services

Commerce, California, 90022, United States

RECRUITING

University of Pittsburgh Medical Center Children's Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Underage Drinking

Interventions

Choline O-Acetyltransferase

Condition Hierarchy (Ancestors)

Adolescent BehaviorBehaviorAlcohol DrinkingDrinking Behavior

Intervention Hierarchy (Ancestors)

AcetyltransferasesAcyltransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Officials

  • Elizabeth J. D'Amico, PhD

    RAND

    PRINCIPAL INVESTIGATOR
  • Alina I Palimaru, PhD

    RAND

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth J D'Amico, PhD

CONTACT

Michael J Woodward

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Enhanced Usual Care vs Chat Intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2024

First Posted

November 21, 2024

Study Start

April 28, 2025

Primary Completion (Estimated)

July 28, 2028

Study Completion (Estimated)

February 28, 2029

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations