School Interventions for Adolescent Alcohol Use

(OASIS Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Passive consent declined

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

18000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Expanded Paraprofessional Workforce, Indicated Prevention, Selective Prevention for adolescent alcohol use?

Training community-based paraprofessionals in behavior therapy to work with families of alcohol-abusing adolescents has shown encouraging results, suggesting that structured interventions by trained paraprofessionals can be effective in reducing alcohol use among adolescents. ^{1 2 3 4 5}

Is the school intervention for adolescent alcohol use safe for humans?

The research does not specifically address safety concerns, but the interventions involve training community workers and school programs, which are generally considered safe as they focus on education and behavior change rather than medical treatments. ^{1 4 6 7 8}

How is the treatment 'Expanded Paraprofessional Workforce, Indicated Prevention, Selective Prevention' different from other treatments for adolescent alcohol use?

This treatment is unique because it involves school-based interventions that focus on building personal and social skills to help students resist alcohol use, using interactive teaching methods, and involving peer leaders. It also integrates other community segments and provides ongoing support to facilitators, making it a comprehensive approach compared to traditional methods. ^{1 9 10 11 12}

Research Team

Randi M Schuster, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for high school students in Massachusetts who are enrolled in a grade that's participating in the SBIRT program. Students can join if their parents or guardians haven't opted out. The study focuses on preventing and addressing alcohol use and other risky behaviors among adolescents.

Inclusion Criteria

I am a high school student eligible for SBIRT.

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete a baseline survey prior to school-wide screening for SBIRT

1 week

1 visit (in-person)

Intervention

Brief interventions delivered based on screening results, with expanded workforce involving school staff and paraprofessionals

24 months

4 follow-up surveys (every 6 months)

Follow-up

Participants are monitored for alcohol use, mental health, and substance use outcomes

24 months

4 visits (in-person or virtual)

Treatment Details

Interventions

• Expanded Paraprofessional Workforce
• Indicated Prevention
• Selective Prevention

Trial Overview The study tests whether brief interventions by clinical staff or trained paraprofessionals at schools can help prevent or reduce substance abuse among teens. Schools will be randomly assigned to one of four different intervention strategies, with follow-up surveys over two years.

Participant Groups

Group I: SIP, CLIN+PARA Experimental Treatment 3 Interventions

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.

Group II: SIP, CLIN Experimental Treatment 2 Interventions

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.

Group III: IPO, CLIN+PARA Experimental Treatment 2 Interventions

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.

Group IV: IPO, CLIN Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Harvard University

Collaborator

Trials

237

Recruited

588,000+

C4 Innovations, LLC

Collaborator

Trials

1

Recruited

18,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

School-based programs to prevent and reduce alcohol use among youth. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Characteristics of alcohol use by school children in a northcentral Wisconsin county. [2004]

3. United States pubmed.ncbi.nlm.nih.gov

Screening and counseling for adolescent alcohol use among primary care physicians in the United States. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Training community-based paraprofessionals as behavior therapists with families of alcohol-abusing adolescents. [2004]

5. United States pubmed.ncbi.nlm.nih.gov

Screening adolescents for substance use: The role of NPs in school settings. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Six-month outcomes of an alcohol prevention program for inner-city youth. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Preventing alcohol use with a voluntary after-school program for middle school students: results from a cluster randomized controlled trial of CHOICE. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Prevention of hazardous use of alcohol among high school students: a study protocol for the randomized controlled trial 'Our choice'. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Adolescent substance use disorders in the school setting. [2011]

10. England pubmed.ncbi.nlm.nih.gov

Brief school-based interventions and behavioural outcomes for substance-using adolescents. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Brief school-based interventions and behavioural outcomes for substance-using adolescents. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Systematic review of universal school-based resilience interventions targeting adolescent tobacco, alcohol or illicit drug use: review protocol. [2021]