ClinicalTrials.gg
RecruitingNCT06699251Updated Sep 9, 2026

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

An interventional study of Chat and Enhanced Usual Care in Adolescent Drinking and Cannabis Use, sponsored by RAND. Recruiting at 3 sites in United States. Open to participants aged 12 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by RAND · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
12 Years to 19 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Adolescent Drinking
  • Cannabis Use

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03

In context

Underage Drinking

44 studies on the registry are indexed under Underage Drinking; 13 are open to participants now.

This study's planned enrollment of 500 is above the median of 360 across 43 interventional studies indexed under Underage Drinking.

Browse Underage Drinking studies →

Lead sponsor

RAND is the lead sponsor of 114 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • if they don't meet the inclusion criteria, they will be excluded
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralChat

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

  • BehavioralEnhanced Usual Care

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 3 months

  2. 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.

    Time frame: 3 months to 6 months

  3. 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.

    Time frame: 6 months to 12 months

  4. 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.

    Time frame: Baseline to 3 months

  5. 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.

    Time frame: 3 months to 6 months

  6. 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.

    Time frame: 6 months to 12 months

  7. 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).

    Time frame: Baseline to 3 months

  8. 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).

    Time frame: 3 months to 6 months

  9. 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).

    Time frame: 6 months to 12 months

  10. 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).

    Time frame: Baseline to 3 months

  11. 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).

    Time frame: 3 months to 6 months

  12. 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).

    Time frame: 6 months to 12 months

Secondary outcomes

  1. 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).

    Time frame: Baseline to 3 months

  2. 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).

    Time frame: 3 months to 6 months

  3. 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).

    Time frame: 6 months to 12 months

  4. 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).

    Time frame: Baseline to 3 months

  5. 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).

    Time frame: 3 months to 6 months

  6. 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).

    Time frame: 6 months to 12 months

  7. 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."

    Time frame: Baseline to 3 months

  8. 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."

    Time frame: 3 months to 6 months

  9. 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."

    Time frame: 6 months to 12 months

  10. 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."

    Time frame: Baseline to 3 months

  11. 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."

    Time frame: 3 months to 6 months

  12. 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."

    Time frame: 6 months to 12 months

  13. 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).

    Time frame: Baseline to 3 months

  14. 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).

    Time frame: 3 months to 6 months

  15. 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).

    Time frame: 6 months to 12 months

07

Study locations

3 of 3 sites recruiting
  • AltaMed Health Services
    Commerce, California 90022, United States
    Recruiting
  • Valley Community Healthcare
    North Hollywood, California 91605, United States
    Recruiting
  • University of Pittsburgh Medical Center Children's Hospital
    Pittsburgh, Pennsylvania 15213, United States
    Recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for Jul 2028, 39 months after the start.

Of 34 non-industry interventional studies with no phase under Underage Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's planned 39 months is above that.

Counting every sponsor, half of 36 studies reached it within 24 months; a quarter within 12 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2024
First posted
Nov 21, 2024
StartActual
Apr 28, 2025
Primary completionEst.
Jul 28, 2028
CompletionEst.
Feb 28, 2029
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06699251
Lead sponsor
RAND
Collaborators
AltaMed Health Services Corporation, University of Pittsburgh Medical Center, Patient-Centered Outcomes Research Institute, Valley Community Healthcare
Responsible party
Sponsor
First posted
Nov 21, 2024
Start date
Apr 28, 2025
Primary completion
Jul 28, 2028 (estimated)
Completion
Feb 28, 2029 (estimated)
Last update
Sep 9, 2026

Study contacts

Elizabeth J D'Amico, PhD
Contact
damico@rand.org
3103930411 ext. 6487
Michael J Woodward
Contact
michaelw@rand.org
3103930411 ext. 6595
Elizabeth J. D'Amico, PhD
principal investigator · RAND
Alina I Palimaru, PhD
principal investigator · RAND

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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