Clinical trial NCT06206161: Optimizing and Advancing SBIRT in Schools
Official title: Testing Scalable, Broad-Reach School-Based Brief Interventions for Alcohol Use
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Adolescent Drinking
Adolescent Substance Use
Risk Behavior, Health
Keywords: Alcohol Use
Screening, Brief Intervention, Referral to Treatment (SBIRT)
Prevention
Expanded Workforce
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: C4 Innovations, LLC
name: Harvard University
name: Patient-Centered Outcomes Research Institute
First posted: 2024-01-16
Enrollment: 18000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Past 30-day alcohol use frequency
timeFrame: 6, 12, 18, and 24 months
measure: Past 30-day cannabis use frequency
timeFrame: 6, 12, 18, and 24 months
measure: Past 30-day nicotine use frequency
timeFrame: 6, 12, 18, and 24 months
Secondary outcomes:
measure: Number of Alcohol Problems
timeFrame: 6, 12, 18, and 24 months
measure: Binge Drinking Episode Frequency
timeFrame: 6, 12, 18, and 24 months
measure: Past 2-week depression symptoms
timeFrame: 6, 12, 18, and 24 months
measure: Past-year thoughts of suicide
timeFrame: 12 and 24 months
measure: Past 2-week anxiety symptoms
timeFrame: 6, 12, 18, and 24 months
measure: Number of Referrals
timeFrame: 6, 12, 18, and 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hopsital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Randi M Schuster, PhD
role: PRINCIPAL_INVESTIGATOR
References: