Adolescent DrinkingOASISNCT06206161
Optimizing and Advancing SBIRT in Schools
A study testing Indicated Prevention, Clinical Staff, Selective Prevention and Expanded Paraprofessional Workforce in people with Adolescent Drinking and Adolescent Substance Use, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to establish whether brief interventions for alcohol use can be delivered in schools for both indicated prevention and selected prevention, determine if an expanded workforce is an effective model for screening, brief intervention, and referral to treatment (SBIRT) delivery in… Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Adolescent Drinking, Adolescent Substance Use, Risk Behavior, Health
- What is being tested?
- Indicated Prevention, Clinical Staff, Selective Prevention and Expanded Paraprofessional Workforce
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2023to 11 Nov 2027
- 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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Enrolled in a participating high school and in the grade scheduled to receive SBIRT
Who cannot join
- Passive consent declined by parent/guardian through the opt-out model
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hopsital
Boston, Massachusetts, 02114
About this study
Official title: Testing Scalable, Broad-Reach School-Based Brief Interventions for Alcohol Use
The goal of this clinical trial is to establish whether brief interventions for alcohol use can be delivered in schools for both indicated prevention and selected prevention, determine if an expanded workforce is an effective model for screening, brief intervention, and referral to treatment (SBIRT) delivery in schools, and explore whether brief intervention effectiveness is comparable in minoritized versus non-minoritized adolescents.
Participants will be students at high schools across Massachusetts. High schools will be randomized to one of four intervention groups. Participants will complete a baseline survey prior to their school-wide screening for SBIRT, and then will complete four follow-up surveys over two years.
Read the detailed description
Massachusetts is the only state in the United States that mandates annual Screening, Brief Intervention and Referral to Treatment (SBIRT) assessments in public middle and high schools. SBIRT includes administering a validated screening instrument (CRAFFT + N) to all students in a single grade and then, based on responses on the screen, delivering a brief intervention (BI) to increase motivation to reduce substance use. While SBIRT represents a positive step in utilizing schools to enhance youth health, current BI implementation has limitations. Firstly, robust BIs primarily target youth already engaged in risky drinking, potentially neglecting those in need of early intervention. Secondly, relying on nursing and clinical staff for BI delivery strains an already burdened workforce. Exploring the inclusion of paraprofessionals, such as peers and mentors, can alleviate this burden and expand outreach. Lastly, there's a gap in ensuring the effectiveness of BIs for minoritized youth who face greater risks of alcohol-related issues.
The purpose of this study is to: 1) Establish whether BIs can be delivered in schools for both indicated prevention - i.e., for high-risk adolescents who already have signs of alcohol problems-and selective prevention - i.e., for moderate-risk adolescents prior to the emergence of problems from use. Public health recommendations for substance use prevention unequivocally advocate for the delivery of interventions as early in the use trajectory as possible. The entire foundation of SBIRT is predicated on this notion. However, BIs have largely been tested only in risky drinkers. (2) Determining if an expanded workforce is an effective model for SBIRT delivery in schools. While SBIRT has historically relied on nurse and clinician facilitation, there is a significant behavioral health workforce shortage that may hamper long-term sustainability, result in incomplete access for low-to-moderate-risk students, and magnify inequities in under-resourced schools. Other behavioral health disciplines have found great promise in embedding trained paraprofessionals into clinical workflow, but this has not been examined for school-based SBIRT. (3) Exploring whether BI effectiveness is comparable in minoritized vs non-minoritized adolescents. While preliminary studies have shown SBIRT to improve system equity and efficiency, this does not always translate to consistent screening and culturally responsive care. This study will explicitly seek to explore heterogeneity in BI effectiveness and use this to inform the development of more equitable, culturally responsive interventions to reduce disparities and increase access.
To address these scientific gaps, the research team aims to test the effects of (1) standard vs expanded criteria for BI eligibility (IPO [TAU] vs. SIP) and (2) standard vs expanded SBIRT workforce (CLIN [TAU] vs. CLIN+PARA) on alcohol, other substance use, and mental health outcomes over 24 months. Investigators will conduct 2x2 analyses of these effects in a cluster randomized trial of 40 high schools in Massachusetts, in which the investigators will survey ~21,000 10th-grade adolescent students over two years and analyze data from a conservative estimate of ~1,900 with past-year alcohol use. The investigators will also enroll an estimated 19,100 students with never or less than past year alcohol use to explore the impact of the target BI intervention strategies (BI eligibility criteria and SBIRT workforce) on initiation of alcohol use and progression among those with low-risk (i.e., never or less than past-year) alcohol use. Participants will be assessed prior to SBIRT screening and then approximately every six months over a 24-month follow-up period. The length of this follow-up period will allow assessment of alcohol use across critical developmental windows during which progression is most common (i.e., 10th through 12th grade, inclusive of two summer vacations). Investigators hypothesize that BIs delivered with expanded eligibility criteria and an expanded workforce, i.e., SIP and CLIN+PARA, will be associated with better substance use and mental health outcomes across the four post-baseline sessions because more proactive prevention will provide skills to more students to buffer against the risk of progression earlier in the substance use trajectory. An expanded workforce will have more time to deliver BIs, follow-up, and referrals, resulting in greater capacity for higher doses of BIs in schools. The investigators suggest that expanded eligibility and an expanded workforce are best deployed in tandem because more inclusive prevention targets (i.e., via SIP) will inevitably result in larger caseloads, and paraprofessionals with dedicated time can help mitigate this burden.
The qualitative aims for this study will be to explore barriers to implementing the studied BI approaches and heterogeneity in BI effects in REM, LBGTQ+, and ELL participants. To accomplish the first part of this aim, investigators will conduct individual semi-structured interviews with school staff and paraprofessionals to assess beliefs around school-based substance use prevention as well as structural factors that may impact access to supports, effectiveness, and sustainability. The study team will also conduct 80 individual interviews with students enrolled in the longitudinal study. Interview participants will be samples by treatment arm (CLIN+PARA versus CLIN; IPO versus SIP), substance use status (low/moderate versus high), and minority status (REM, LGBTQIA+, ELL).
- Being tested
- Indicated Prevention, Clinical Staff, Selective Prevention, Expanded Paraprofessional Workforce
- Keywords
- Alcohol Use, Screening, Brief Intervention, Referral to Treatment (SBIRT), Prevention, Expanded Workforce
- Medical subject headings
- Underage Drinking, Health Risk Behaviors, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indicated Prevention, Clinical StaffBehavioural
Standard brief intervention eligibility criteria involving indicated prevention (i.e., brief interventions delivered to high-risk drinkers only). BIs delivered by standard SBIRT workforce involving school nursing or clinical staff.
Selective PreventionBehavioural
Expanded brief intervention eligibility criteria involving selective prevention in addition to indicated prevention (i.e., brief interventions delivered to current drinkers with and without risky alcohol use).
Expanded Paraprofessional WorkforceBehavioural
Brief interventions delivered by expanded SBIRT workforce involving school nursing or clinical staff and trained paraprofessionals.
| Study group | Role | What they receive |
|---|---|---|
| IPO, CLIN | Active comparator | Standard brief intervention eligibility criteria involving indicated prevention (i.e., brief interventions delivered to high-risk drinkers only). BIs delivered by standard SBIRT workforce involving school nursing or clinical staff. Receives: Behavioral: Indicated Prevention, Clinical Staff |
| IPO, CLIN+PARA | Experimental | Standard brief intervention eligibility criteria involving indicated prevention (i.e., brief interventions delivered to high-risk drinkers only). BIs delivered by expanded SBIRT workforce involving school nursing or clinical staff and trained paraprofessionals. Receives: Behavioral: Indicated Prevention, Clinical Staff; Behavioral: Expanded Paraprofessional Workforce |
| SIP, CLIN | Experimental | Expanded brief intervention eligibility criteria involving selective prevention in addition to indicated prevention (i.e., brief interventions delivered to current drinkers with and without risky alcohol use). BIs delivered by standard SBIRT workforce involving school nursing or clinical staff. Receives: Behavioral: Indicated Prevention, Clinical Staff; Behavioral: Selective Prevention |
| SIP, CLIN+PARA | Experimental | Expanded brief intervention eligibility criteria involving selective prevention in addition to indicated prevention (i.e., brief interventions delivered to current drinkers with and without risky alcohol use). BIs delivered by expanded SBIRT workforce involving school nursing or clinical staff and trained paraprofessionals. Receives: Behavioral: Indicated Prevention, Clinical Staff; Behavioral: Selective Prevention; Behavioral: Expanded Paraprofessional Workforce |
What is being measured
The primary outcome is the main question the study is designed to answer.
Past 30-day alcohol use frequency
Past 30-day alcohol use frequency (number of days) will be assessed via self-report questions from the Monitoring the Future (MTF) survey.
Measured: 6, 12, 18, and 24 months
Past 30-day cannabis use frequency
Past 30-day cannabis use frequency (number of days) will be assessed via self-report questions from the Monitoring the Future (MTF) survey.
Measured: 6, 12, 18, and 24 months
Past 30-day nicotine use frequency
Past 30-day nicotine use frequency (number of days) will be assessed via self-report questions from the Monitoring the Future (MTF) survey.
Measured: 6, 12, 18, and 24 months
Secondary outcomes (6)
Number of Alcohol Problems
Number of alcohol-related problems will be assessed using the Alcohol Use Disorders Identification Test (AUDIT). The AUDIT has a range from 0 to 40, with higher scores indicating more alcohol-related problems. Scores of 5 or greater indicate hazardous drinking in adolescents.
Measured: 6, 12, 18, and 24 months
Binge Drinking Episode Frequency
Binge drinking episode frequency will be assessed via self-report questions from the Monitoring the Future (MTF) survey. Assessments will use a developmentally-scaled definition of binge drinking defined as ≥4 drinks and ≥3 drinks in two hours for 14-15 year old males and females, respectively, and ≥5 drinks and ≥3 drinks in two hours for 16-17 year old males and females, respectively.
Measured: 6, 12, 18, and 24 months
Past 2-week depression symptoms
Depression symptoms will be assessed using the Depression subscale of the Patient Health Questionnaire-4 (PHQ-4). This subscale ranges from 0-6, with higher scores indicating greater symptoms burden. Scores of 3 or greater on the depression subscale of the PHQ-4 are suggestive of potential cases of major depression or other depressive disorders.
Measured: 6, 12, 18, and 24 months
Past-year thoughts of suicide
Past-year thoughts of suicide will be assessed using a self-report measure. The measure will query about past-year passive suicidal ideation, active suicidal ideation, suicidal preparatory acts and behavior, and non-suicidal self-injury. Binary (yes/no) response options will be provided.
Measured: 12 and 24 months
Past 2-week anxiety symptoms
Anxiety symptoms will be assessed using the Depression subscale of the Patient Health Questionnaire-4 (PHQ-4). This subscale ranges from 0-6, with higher scores indicating greater symptoms burden. Scores of 3 or greater on the Anxiety subscale of the PHQ-4 are suggestive of potential cases of generalized anxiety, panic, social anxiety, and posttraumatic stress disorders.
Measured: 6, 12, 18, and 24 months
Number of Referrals
The number of referrals to follow-up support services will be assessed via self-report questionnaire. Subjects will be asked whether they have met with someone at school (not including a friend or another student) since their last assessment about mental health and substance use (yes/no). If yes, they will receive additional questions to understand the role of the person/people they met with, topics addressed, duration and intensity of the encounter(s), and perceived helpfulness of the support received.
Measured: 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start11 Oct 2023
- Primary completion11 Nov 2027 (estimated)
- Study completion11 Nov 2027 (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.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 21,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- C4 Innovations, LLC, Harvard University, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Randi Melissa Schuster, Massachusetts General Hospital
- Investigators
- Randi M Schuster, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206161
- Sponsor's protocol ID
- 2023P000998
- Other IDs
- AU-2022C1-26355
- Acronym
- OASIS
- Status last verified
- Nov 2025
- First submitted
- 4 Jan 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full data package, which includes the de-identified analyzable data set, full protocol, metadata, data dictionary, full statistical analysis plan (including all amendments and all documentation for additional work processes), and analytic code, will be shared with a controlled-access, PCORI-designated repository as outlined in the PCORI Policy for Data Management and Data Sharing.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Scalable, Broad-Reach School-Based Brief Interventions for Alcohol Use
- ClinicalTrials.gov ID
- NCT06206161
- Acronym / sponsor ID
- OASIS / 2023P000998
- Keywords
- Alcohol Use, Screening, Brief Intervention, Referral to Treatment (SBIRT), Prevention, Expanded Workforce
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 21,000 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- C4 Innovations, LLC, Harvard University, Patient-Centered Outcomes Research Institute
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 11 Nov 2027 (estimated)
- Study completion
- 11 Nov 2027 (estimated)
- First posted
- 16 Jan 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.
The goal of this clinical trial is to establish whether brief interventions for alcohol use can be delivered in schools for both indicated prevention and selected prevention, determine if an expanded workforce is an effective model for screening, brief intervention, and referral to treatment (SBIRT) delivery in schools, and explore whether brief intervention effectiveness is comparable in minoritized versus non-minoritized adolescents.
Participants will be students at high schools across Massachusetts. High schools will be randomized to one of four intervention groups. Participants will complete a baseline survey prior to their school-wide screening for SBIRT, and then will complete four follow-up surveys over two years.
Detailed description
Massachusetts is the only state in the United States that mandates annual Screening, Brief Intervention and Referral to Treatment (SBIRT) assessments in public middle and high schools. SBIRT includes administering a validated screening instrument (CRAFFT + N) to all students in a single grade and then, based on responses on the screen, delivering a brief intervention (BI) to increase motivation to reduce substance use. While SBIRT represents a positive step in utilizing schools to enhance youth health, current BI implementation has limitations. Firstly, robust BIs primarily target youth already engaged in risky drinking, potentially neglecting those in need of early intervention. Secondly, relying on nursing and clinical staff for BI delivery strains an already burdened workforce. Exploring the inclusion of paraprofessionals, such as peers and mentors, can alleviate this burden and expand outreach. Lastly, there's a gap in ensuring the effectiveness of BIs for minoritized youth who face greater risks of alcohol-related issues.
The purpose of this study is to: 1) Establish whether BIs can be delivered in schools for both indicated prevention - i.e., for high-risk adolescents who already have signs of alcohol problems-and selective prevention - i.e., for moderate-risk adolescents prior to the emergence of problems from use. Public health recommendations for substance use prevention unequivocally advocate for the delivery of interventions as early in the use trajectory as possible. The entire foundation of SBIRT is predicated on this notion. However, BIs have largely been tested only in risky drinkers. (2) Determining if an expanded workforce is an effective model for SBIRT delivery in schools. While SBIRT has historically relied on nurse and clinician facilitation, there is a significant behavioral health workforce shortage that may hamper long-term sustainability, result in incomplete access for low-to-moderate-risk students, and magnify inequities in under-resourced schools. Other behavioral health disciplines have found great promise in embedding trained paraprofessionals into clinical workflow, but this has not been examined for school-based SBIRT. (3) Exploring whether BI effectiveness is comparable in minoritized vs non-minoritized adolescents. While preliminary studies have shown SBIRT to improve system equity and efficiency, this does not always translate to consistent screening and culturally responsive care. This study will explicitly seek to explore heterogeneity in BI effectiveness and use this to inform the development of more equitable, culturally responsive interventions to reduce disparities and increase access.
To address these scientific gaps, the research team aims to test the effects of (1) standard vs expanded criteria for BI eligibility (IPO [TAU] vs. SIP) and (2) standard vs expanded SBIRT workforce (CLIN [TAU] vs. CLIN+PARA) on alcohol, other substance use, and mental health outcomes over 24 months. Investigators will conduct 2x2 analyses of these effects in a cluster randomized trial of 40 high schools in Massachusetts, in which the investigators will survey ~21,000 10th-grade adolescent students over two years and analyze data from a conservative estimate of ~1,900 with past-year alcohol use. The investigators will also enroll an estimated 19,100 students with never or less than past year alcohol use to explore the impact of the target BI intervention strategies (BI eligibility criteria and SBIRT workforce) on initiation of alcohol use and progression among those with low-risk (i.e., never or less than past-year) alcohol use. Participants will be assessed prior to SBIRT screening and then approximately every six months over a 24-month follow-up period. The length of this follow-up period will allow assessment of alcohol use across critical developmental windows during which progression is most common (i.e., 10th through 12th grade, inclusive of two summer vacations). Investigators hypothesize that BIs delivered with expanded eligibility criteria and an expanded workforce, i.e., SIP and CLIN+PARA, will be associated with better substance use and mental health outcomes across the four post-baseline sessions because more proactive prevention will provide skills to more students to buffer against the risk of progression earlier in the substance use trajectory. An expanded workforce will have more time to deliver BIs, follow-up, and referrals, resulting in greater capacity for higher doses of BIs in schools. The investigators suggest that expanded eligibility and an expanded workforce are best deployed in tandem because more inclusive prevention targets (i.e., via SIP) will inevitably result in larger caseloads, and paraprofessionals with dedicated time can help mitigate this burden.
The qualitative aims for this study will be to explore barriers to implementing the studied BI approaches and heterogeneity in BI effects in REM, LBGTQ+, and ELL participants. To accomplish the first part of this aim, investigators will conduct individual semi-structured interviews with school staff and paraprofessionals to assess beliefs around school-based substance use prevention as well as structural factors that may impact access to supports, effectiveness, and sustainability. The study team will also conduct 80 individual interviews with students enrolled in the longitudinal study. Interview participants will be samples by treatment arm (CLIN+PARA versus CLIN; IPO versus SIP), substance use status (low/moderate versus high), and minority status (REM, LGBTQIA+, ELL).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IPO, CLIN | Active comparator | Behavioral: Indicated Prevention, Clinical StaffStandard brief intervention eligibility criteria involving indicated prevention (i.e., brief interventions delivered to high-risk drinkers only). BIs delivered by standard SBIRT workforce involving school nursing or clinical staff. |
| IPO, CLIN+PARA | Experimental | Behavioral: Indicated Prevention, Clinical Staff, Behavioral: Expanded Paraprofessional WorkforceStandard brief intervention eligibility criteria involving indicated prevention (i.e., brief interventions delivered to high-risk drinkers only). BIs delivered by expanded SBIRT workforce involving school nursing or clinical staff and trained paraprofessionals. |
| SIP, CLIN | Experimental | Behavioral: Indicated Prevention, Clinical Staff, Behavioral: Selective PreventionExpanded brief intervention eligibility criteria involving selective prevention in addition to indicated prevention (i.e., brief interventions delivered to current drinkers with and without risky alcohol use). BIs delivered by standard SBIRT workforce involving school nursing or clinical staff. |
| SIP, CLIN+PARA | Experimental | Behavioral: Indicated Prevention, Clinical Staff, Behavioral: Selective Prevention, Behavioral: Expanded Paraprofessional WorkforceExpanded brief intervention eligibility criteria involving selective prevention in addition to indicated prevention (i.e., brief interventions delivered to current drinkers with and without risky alcohol use). BIs delivered by expanded SBIRT workforce involving school nursing or clinical staff and trained paraprofessionals. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Enrolled in a participating high school and in the grade scheduled to receive SBIRT
Key exclusion criteria (1 listed)
- Passive consent declined by parent/guardian through the opt-out model
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 |
|---|---|---|
| Indicated Prevention, Clinical StaffStandard brief intervention eligibility criteria involving indicated prevention (i.e., brief interventions delivered to high-risk drinkers only). BIs delivered by standard SBIRT workforce involving school nursing or clinical staff. | Behavioural | IPO, CLIN, IPO, CLIN+PARA, SIP, CLIN, SIP, CLIN+PARA |
| Selective PreventionExpanded brief intervention eligibility criteria involving selective prevention in addition to indicated prevention (i.e., brief interventions delivered to current drinkers with and without risky alcohol use). | Behavioural | SIP, CLIN, SIP, CLIN+PARA |
| Expanded Paraprofessional WorkforceBrief interventions delivered by expanded SBIRT workforce involving school nursing or clinical staff and trained paraprofessionals. | Behavioural | IPO, CLIN+PARA, SIP, CLIN+PARA |
Primary outcome
Past 30-day alcohol use frequency
Time frame: 6, 12, 18, and 24 months
Past 30-day alcohol use frequency (number of days) will be assessed via self-report questions from the Monitoring the Future (MTF) survey.
Past 30-day cannabis use frequency
Time frame: 6, 12, 18, and 24 months
Past 30-day cannabis use frequency (number of days) will be assessed via self-report questions from the Monitoring the Future (MTF) survey.
Past 30-day nicotine use frequency
Time frame: 6, 12, 18, and 24 months
Past 30-day nicotine use frequency (number of days) will be assessed via self-report questions from the Monitoring the Future (MTF) survey.
6 secondary outcomes
Number of Alcohol Problems
Time frame: 6, 12, 18, and 24 months
Binge Drinking Episode Frequency
Time frame: 6, 12, 18, and 24 months
Past 2-week depression symptoms
Time frame: 6, 12, 18, and 24 months
Past-year thoughts of suicide
Time frame: 12 and 24 months
Past 2-week anxiety symptoms
Time frame: 6, 12, 18, and 24 months
Number of Referrals
Time frame: 6, 12, 18, and 24 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 26 Nov 2025.
- Individual participant dataSharing planned: Yes. The full data package, which includes the de-identified analyzable data set, full protocol, metadata, data dictionary, full statistical analysis plan (including all amendments and all documentation for additional work processes), and analytic code, will be shared with a controlled-access, PCORI-designated repository as outlined in the PCORI Policy for Data Management and Data Sharing.
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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.
Randi M Schuster, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indicated Prevention, Clinical Staff, Selective Prevention and Expanded Paraprofessional Workforce in people with Adolescent Drinking and Adolescent Substance Use, run by Massachusetts General Hospital at 1 site 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 1 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: enrolling by invitation, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Past 30-day alcohol use frequency (time frame: 6, 12, 18, and 24 months). The study lists 3 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 26 Nov 2025; AzTrials last refreshed its copy on 27 Oct 2026.