Effectiveness of Brief Intervention in Primary Care for Diverse Young People (Chat)

September 3, 2026 updated by: RAND

Effectiveness of Brief Intervention in Primary Care for Diverse Young People

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The six-item CRAFFT will be used to screen teens at our partner clinics for risky AC use. For those that screen in as at-risk and express interest in the study, the teen's case manager will complete an online consent/assent form with the parent and teen that contains contact information for the teen so that investigators can follow up with the teen for surveys and intervention delivery or for providing an informational brochure. 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. Investigators expect each teen to be scheduled within 30 days of completing their baseline survey to receive EUC or Chat. The informational brochure for the EUC will be handed to the teen during the visit or securely emailed, and Chat could take place either via a virtual or in-person visit. Whether or not the teen completes EUC or Chat, every teen will be followed by the RAND Survey Research Group to complete their follow-up web-based surveys based on timing of completion of their baseline survey. Teens will receive gift card incentives for completing the 3-month, 6-month, and 12-month surveys. Investigators will begin recruitment in month 9 of the project. Briefly, investigators expect to recruit from study month 9 to month 42 for the baseline survey. Investigators expect the Chat intervention to occur from months 9 to 42 the 3-month follow-up from months 12 to 45, 6-month from months 15 to 48, and the 12-month from months 21 to 53. Out of an anticipated 5,644 clients that our partner clinics will screen, investigators expect approximately 847 (15%) to screen in as at-risk on the CRAFFT and anticipate that approximately 500 (~60%) will consent into the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Elizabeth J D'Amico, PhD
  • Phone Number: 6487 3103930411
  • Email: damico@rand.org

Study Contact Backup

Study Locations

  • United States
    • California
      • Commerce, California, United States, 90022
        • Recruiting
        • AltaMed Health Services
        • Contact:
      • North Hollywood, California, United States, 91605
        • Recruiting
        • Valley Community Healthcare
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • if they don't meet the inclusion criteria, they will be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Enhanced Usual Care
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
An informational brochure will be give to partner clinic participants with an alcohol or cannabis use condition.
Experimental: Chat Intervention
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
Chat is a brief motivational interviewing intervention for partner clinic participants with an alcohol or cannabis use condition.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Alcohol - change in frequency of use
Time Frame: Baseline to 3 months
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
Time Frame: 3 months to 6 months
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
Time Frame: 6 months to 12 months
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
Time Frame: Baseline to 3 months
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
Time Frame: 3 months to 6 months
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
Time Frame: 6 months to 12 months
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
Time Frame: Baseline to 3 months
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
Time Frame: 3 months to 6 months
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
Time Frame: 6 months to 12 months
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
Time Frame: Baseline to 3 months
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
Time Frame: 3 months to 6 months
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
Time Frame: 6 months to 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Alcohol - change in time spent around peers
Time Frame: Baseline to 3 months
Participants will be asked how often they are with people their age who are using alcohol (1=never to 4=often).
Baseline to 3 months
Alcohol - change in time spent around peers
Time Frame: 3 months to 6 months
Participants will be asked how often they are with people their age who are using alcohol (1=never to 4=often).
3 months to 6 months
Alcohol - change in time spent around peers
Time Frame: 6 months to 12 months
Participants will be asked how often they are with people their age who are using alcohol (1=never to 4=often).
6 months to 12 months
Cannabis - change in time spent around peers
Time Frame: Baseline to 3 months
Participants will be asked how often they are with people their age who are using cannabis (1=never to 4=often).
Baseline to 3 months
Cannabis - change in time spent around peers
Time Frame: 3 months to 6 months
Participants will be asked how often they are with people their age who are using cannabis (1=never to 4=often).
3 months to 6 months
Cannabis - change in time spent around peers
Time Frame: 6 months to 12 months
Participants will be asked how often they are with people their age who are using cannabis (1=never to 4=often).
6 months to 12 months
Alcohol - change in motivation to change use
Time Frame: Baseline to 3 months
We will measure motivation to change use by asking participants where they may be in their thinking about reducing or quitting their alcohol use using a scale of 1-10 where 1 = "I have quit using alcohol and will never go back" and 10 = "I enjoy using alcohol and have decided never to change it."
Baseline to 3 months
Alcohol - change in motivation to change use
Time Frame: 3 months to 6 months
We will measure motivation to change use by asking participants where they may be in their thinking about reducing or quitting their alcohol use using a scale of 1-10 where 1 = "I have quit using alcohol and will never go back" and 10 = "I enjoy using alcohol and have decided never to change it."
3 months to 6 months
Alcohol - change in motivation to change use
Time Frame: 6 months to 12 months
We will measure motivation to change use by asking participants where they may be in their thinking about reducing or quitting their alcohol use using a scale of 1-10 where 1 = "I have quit using alcohol and will never go back" and 10 = "I enjoy using alcohol and have decided never to change it."
6 months to 12 months
Cannabis - change in motivation to change use
Time Frame: Baseline to 3 months
We will measure motivation to change use by asking participants where they may be in their thinking about reducing or quitting their cannabis use using a scale of 1-10 where 1 = "I have quit using cannabis and will never go back" and 10 = "I enjoy using cannabis and have decided never to change it."
Baseline to 3 months
Cannabis - change in motivation to change use
Time Frame: 3 months to 6 months
We will measure motivation to change use by asking participants where they may be in their thinking about reducing or quitting their cannabis use using a scale of 1-10 where 1 = "I have quit using cannabis and will never go back" and 10 = "I enjoy using cannabis and have decided never to change it."
3 months to 6 months
Cannabis - change in motivation to change use
Time Frame: 6 months to 12 months
We will measure motivation to change use by asking participants where they may be in their thinking about reducing or quitting their cannabis use using a scale of 1-10 where 1 = "I have quit using cannabis and will never go back" and 10 = "I enjoy using cannabis and have decided never to change it."
6 months to 12 months
Change in use of behavioral health care services
Time Frame: Baseline to 3 months
We will measure use of behavioral health care services (separate items for mental health and substance use), including whether there are unmet needs for behavioral health services (i.e., perceived a need to get treatment but didn't get it) and perceived reasons for those unmet needs (e.g., stigma, transportation, cost).
Baseline to 3 months
Change in use of behavioral health care services
Time Frame: 3 months to 6 months
We will measure use of behavioral health care services (separate items for mental health and substance use), including whether there are unmet needs for behavioral health services (i.e., perceived a need to get treatment but didn't get it) and perceived reasons for those unmet needs (e.g., stigma, transportation, cost).
3 months to 6 months
Change in use of behavioral health care services
Time Frame: 6 months to 12 months
We will measure use of behavioral health care services (separate items for mental health and substance use), including whether there are unmet needs for behavioral health services (i.e., perceived a need to get treatment but didn't get it) and perceived reasons for those unmet needs (e.g., stigma, transportation, cost).
6 months to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RAND

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute
University of Pittsburgh Medical Center
AltaMed Health Services Corporation
Valley Community Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth J. D'Amico, PhD, RAND
  • Principal Investigator: Alina I Palimaru, PhD, RAND

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-N0065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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