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Enrolling by invitation NCT06206161

Optimizing and Advancing SBIRT in Schools

No phase Interventional Adolescent Drinking Adolescent Substance Use Risk Behavior, Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indicated Prevention, Clinical Staff, Selective Prevention, Expanded Paraprofessional Workforce.
Who it may be relevant to
Registry conditions: Adolescent Drinking, Adolescent Substance Use, Risk Behavior, Health. Basic parameters: 14 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Testing Scalable, Broad-Reach School-Based Brief Interventions for Alcohol Use

Overview

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).

Interventions

  • 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).
  • Behavioral Expanded Paraprofessional Workforce
    Brief interventions delivered by expanded SBIRT workforce involving school nursing or clinical staff and trained paraprofessionals.

Primary outcome measures

  • Past 30-day alcohol use frequency [Time frame: 6, 12, 18, and 24 months]
  • Past 30-day cannabis use frequency [Time frame: 6, 12, 18, and 24 months]
  • Past 30-day nicotine use frequency [Time frame: 6, 12, 18, and 24 months]
Secondary outcome measures (6)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Massachusetts General Hopsital — Boston

Identifiers

NCT: NCT06206161 · 2023P000998 · AU-2022C1-26355

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗