Optimizing and Advancing SBIRT in Schools
OASIS
Testing Scalable, Broad-Reach School-Based Brief Interventions for Alcohol Use
2 other identifiers
interventional
21,000
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2023
CompletedFirst Submitted
Initial submission to the registry
January 4, 2024
CompletedFirst Posted
Study publicly available on registry
January 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 11, 2027
November 26, 2025
November 1, 2025
4.1 years
January 4, 2024
November 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
6, 12, 18, and 24 months
Secondary Outcomes (6)
Number of Alcohol Problems
6, 12, 18, and 24 months
Binge Drinking Episode Frequency
6, 12, 18, and 24 months
Past 2-week depression symptoms
6, 12, 18, and 24 months
Past-year thoughts of suicide
12 and 24 months
Past 2-week anxiety symptoms
6, 12, 18, and 24 months
- +1 more secondary outcomes
Study Arms (4)
IPO, CLIN
ACTIVE COMPARATORStandard 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
EXPERIMENTALStandard 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
EXPERIMENTALExpanded 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
EXPERIMENTALExpanded 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.
Interventions
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.
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).
Brief interventions delivered by expanded SBIRT workforce involving school nursing or clinical staff and trained paraprofessionals.
Eligibility Criteria
You may qualify if:
- Enrolled in a participating high school and in the grade scheduled to receive SBIRT
You may not qualify if:
- Passive consent declined by parent/guardian through the opt-out model
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- C4 Innovations, LLCcollaborator
- Harvard Universitycollaborator
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (1)
Massachusetts General Hopsital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Randi M Schuster, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 4, 2024
First Posted
January 16, 2024
Study Start
October 11, 2023
Primary Completion (Estimated)
November 11, 2027
Study Completion (Estimated)
November 11, 2027
Last Updated
November 26, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be available within 90 days of submission of the draft final research report and will be maintained in the repository for at least 7 years.
- Access Criteria
- Investigators seeking access to the data from this PCORI-funded trial will need to complete and submit a data access request to the PCORI-designated repository. The repository will review requests based on the qualifications of the investigators and scientific merit. If the request is approved, the requestor's institution will need to enter into a data use agreement with the PCORI-designated repository with will specify terms and conditions for data use.
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.