Optimizing and Advancing SBIRT in Schools (OASIS)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Adolescent Substance Use; Adolescent Drinking; Risk Behavior, Health
• Intervention / Treatment: Behavioral: Indicated Prevention, Clinical Staff; Behavioral: Expanded Paraprofessional Workforce; Behavioral: Selective Prevention

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 30 focus groups with 8-10 adolescent participants each. Participants enrolled in the longitudinal study who identify as at least one of the three target minoritized groups will be invited to participate.

• Study Type: Interventional
• Enrollment (Estimated): 18000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hopsital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Enrolled in a participating high school and in the grade scheduled to receive SBIRT

Exclusion Criteria:

• Passive consent declined by parent/guardian through the opt-out model

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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IPO, CLIN; 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.	Behavioral: Indicated Prevention, Clinical Staff; 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.
Experimental: IPO, CLIN+PARA; 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.	Behavioral: Indicated Prevention, Clinical Staff; 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.; Behavioral: Expanded Paraprofessional Workforce; Brief interventions delivered by expanded SBIRT workforce involving school nursing or clinical staff and trained paraprofessionals.
Experimental: SIP, CLIN; 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.	Behavioral: Indicated Prevention, Clinical Staff; 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.; Behavioral: Selective Prevention; 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).
Experimental: SIP, CLIN+PARA; 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.	Behavioral: Indicated Prevention, Clinical Staff; 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.; Behavioral: Expanded Paraprofessional Workforce; Brief interventions delivered by expanded SBIRT workforce involving school nursing or clinical staff and trained paraprofessionals.; Behavioral: Selective Prevention; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	6, 12, 18, and 24 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Patient-Centered Outcomes Research Institute; Harvard University; C4 Innovations, LLC
• Investigators: Principal Investigator: Randi M Schuster, PhD, Massachusetts General hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Estimated): November 11, 2027
• Study Completion (Estimated): November 11, 2027

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Prevention; Alcohol Use; Screening, Brief Intervention, Referral to Treatment (SBIRT); Expanded Workforce
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol Drinking; Substance-Related Disorders; Underage Drinking
• Other Study ID Numbers: 2023P000998; AU-2022C1-26355 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No