Adolescent DrinkingNCT06699251
Effectiveness of Brief Intervention in Primary Care for Diverse Young People (Chat)
A study testing Chat in people with Adolescent Drinking and Cannabis Use, run by RAND at 3 sites in United States.
Trial summary
Brief motivational interviewing intervention to address alcohol use among diverse teens 12-17. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Drinking, Cannabis Use
- What is being tested?
- Chat
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Apr 2025to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- if they don't meet the inclusion criteria, they will be excluded
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
AltaMed Health Services
Commerce, California, 90022
Sandra Pisano, 888-499-9303, SPisano@altamed.org
- Recruiting
Valley Community Healthcare
North Hollywood, California, 91605
Jill Halper, MD, 818-763-8836, jhalper@vchcare.org
- Recruiting
University of Pittsburgh Medical Center Children's Hospital
Pittsburgh, Pennsylvania, 15213
Ana Radovic, 412-692-6677, Ana.Radovic@chp.edu
About this study
Official title: Effectiveness of Brief Intervention in Primary Care for Diverse Young People
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.
- Conditions
- Adolescent Drinking, Cannabis Use
- Being tested
- Chat, Enhanced Usual Care
- Medical subject headings
- Underage Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatBehavioural
Chat is a brief motivational interviewing intervention for partner clinic participants with an alcohol or cannabis use condition.
Enhanced Usual CareBehavioural
An informational brochure will be give to partner clinic participants with an alcohol or cannabis use condition.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Chat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 months to 12 months
Secondary outcomes (15)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 months to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start28 Apr 2025
- Primary completion28 Jul 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enhanced Usual Care vs Chat Intervention
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- AltaMed Health Services Corporation, University of Pittsburgh Medical Center, Patient-Centered Outcomes Research Institute, Valley Community Healthcare
- Responsible party
- Sponsor
- Investigators
- Elizabeth J. D'Amico, PhD, Principal investigator, RANDAlina I Palimaru, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699251
- Sponsor's protocol ID
- 2024-N0065
- Status last verified
- Sep 2026
- First submitted
- 15 Nov 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Brief Intervention in Primary Care for Diverse Young People
- ClinicalTrials.gov ID
- NCT06699251
- Acronym / sponsor ID
- 2024-N0065
- Conditions
- Adolescent Drinking, Cannabis Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- AltaMed Health Services Corporation, University of Pittsburgh Medical Center, Patient-Centered Outcomes Research Institute, Valley Community Healthcare
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 28 Jul 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brief motivational interviewing intervention to address alcohol use among diverse teens 12-17.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enhanced Usual Care vs Chat Intervention
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareWhen 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. |
| Chat Intervention | Experimental | Behavioral: ChatWhen 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. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- if they don't meet the inclusion criteria, they will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChatChat is a brief motivational interviewing intervention for partner clinic participants with an alcohol or cannabis use condition. | Behavioural | Chat Intervention |
| Enhanced Usual CareAn informational brochure will be give to partner clinic participants with an alcohol or cannabis use condition. | Behavioural | Enhanced Usual Care |
Primary outcome
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).
15 secondary outcomes
Alcohol - change in time spent around peers
Time frame: Baseline to 3 months
Alcohol - change in time spent around peers
Time frame: 3 months to 6 months
Alcohol - change in time spent around peers
Time frame: 6 months to 12 months
Cannabis - change in time spent around peers
Time frame: Baseline to 3 months
Cannabis - change in time spent around peers
Time frame: 3 months to 6 months
Cannabis - change in time spent around peers
Time frame: 6 months to 12 months
Alcohol - change in motivation to change use
Time frame: Baseline to 3 months
Alcohol - change in motivation to change use
Time frame: 3 months to 6 months
Alcohol - change in motivation to change use
Time frame: 6 months to 12 months
Cannabis - change in motivation to change use
Time frame: Baseline to 3 months
Cannabis - change in motivation to change use
Time frame: 3 months to 6 months
Cannabis - change in motivation to change use
Time frame: 6 months to 12 months
Change in use of behavioral health care services
Time frame: Baseline to 3 months
Change in use of behavioral health care services
Time frame: 3 months to 6 months
Change in use of behavioral health care services
Time frame: 6 months to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth J. D'Amico, PhD principal investigator
RAND
Alina I Palimaru, PhD principal investigator
RAND
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chat in people with Adolescent Drinking and Cannabis Use, run by RAND at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth J D'Amico, PhD (3103930411 ext. 6487, damico@rand.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol - change in frequency of use (time frame: Baseline to 3 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.