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

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: Recruiting
• Conditions: Cannabis Use; Adolescent Drinking
• Intervention / Treatment: Behavioral: Enhanced Usual Care; Behavioral: Chat

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: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth J D'Amico, PhD; Phone Number: 6487 3103930411; Email: damico@rand.org
• Study Contact Backup: Name: Michael J Woodward; Phone Number: 6595 3103930411; Email: michaelw@rand.org

Study Locations

• United States
  • California
    • Commerce, California, United States, 90022
      • Recruiting
      • AltaMed Health Services
      • Contact: Sandra Pisano; Phone Number: 888-499-9303; Email: SPisano@altamed.org
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center Children's Hospital
      • Contact: Ana Radovic; Phone Number: 412-692-6677; Email: Ana.Radovic@chp.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol - change in time spent around peers	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: RAND
• Collaborators: Patient-Centered Outcomes Research Institute; University of Pittsburgh Medical Center; AltaMed Health Services Corporation
• Investigators: Principal Investigator: Elizabeth J. D'Amico, PhD, RAND; Principal Investigator: Alina I Palimaru, PhD, RAND

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Estimated): July 28, 2028
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 18, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Behavior; Adolescent Behavior; Underage Drinking; Enzymes; Enzymes and Coenzymes; Transferases; Acetyltransferases; Acyltransferases; Choline O-Acetyltransferase
• Other Study ID 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