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

NCT ID: NCT06699251

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-28

Study Completion Date

2029-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Adolescent Drinking Cannabis Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Enhanced Usual Care vs Chat Intervention
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Chat

Intervention Type BEHAVIORAL

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

Interventions

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Chat

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

Intervention Type BEHAVIORAL

Enhanced Usual Care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AltaMed Health Services Corporation

OTHER

Sponsor Role collaborator

University of Pittsburgh Medical Center

OTHER

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

RAND

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth J. D'Amico, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Alina I Palimaru, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Locations

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AltaMed Health Services

Commerce, California, United States

Site Status RECRUITING

University of Pittsburgh Medical Center Children's Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elizabeth J D'Amico, PhD

Role: CONTACT

3103930411 ext. 6487

Michael J Woodward

Role: CONTACT

3103930411 ext. 6595

Facility Contacts

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Sandra Pisano

Role: primary

888-499-9303

Ana Radovic

Role: primary

412-692-6677

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2024-N0065

Identifier Type: -

Identifier Source: org_study_id

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