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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if brief interventions to reduce alcohol use can be effectively delivered in high schools. It will test various methods of providing these interventions, including using an expanded team of staff and trained helpers (Expanded Paraprofessional Workforce), to identify the most effective approach. The trial also seeks to determine if these interventions are equally effective for all students, regardless of their backgrounds. High school students in Massachusetts who are currently drinking or at risk of drinking might be suitable candidates for this trial. Schools will be randomly assigned to one of four different intervention groups, and students will complete surveys over two years. As an unphased trial, this study offers students the opportunity to contribute to important research that could shape future alcohol intervention programs in schools.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's interventions are likely to be safe?

A previous study showed that using a larger team of trained support staff in schools helped address mental health needs among children and teens. These staff members assist with screening and brief support sessions, and this approach is generally well-received.

Research on programs for high-risk drinkers has found that substance use significantly decreases when students attend at least 60% of the sessions. For programs targeting current drinkers with varying risk levels, studies have noted a reduction in alcohol use and related problems.

These programs focus on behavior and support rather than medical treatments, making them usually safe and well-tolerated. No significant negative effects were reported in these studies, which reassures those considering participation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for adolescent alcohol use because they bring innovative approaches to prevention directly into schools. Unlike traditional methods, which often focus solely on high-risk drinkers, these interventions expand eligibility to include all current drinkers, offering a broader reach. Additionally, they leverage a diverse workforce, including school nurses, clinical staff, and trained paraprofessionals, to deliver brief interventions, making them more accessible and potentially more effective in a school setting. This inclusive and comprehensive strategy could lead to more effective prevention and early intervention among adolescents.

What evidence suggests that this trial's interventions could be effective for adolescent alcohol use?

This trial will compare different school-based interventions for adolescent alcohol use. Research has shown that using a larger team, including trained helpers, can effectively reduce substance use among teenagers. In this trial, some participants will receive interventions delivered by an expanded workforce, including school nursing or clinical staff and trained paraprofessionals. Studies indicate that students who participate in at least 60% of the program drink significantly less alcohol.

Other participants will receive interventions focusing on high-risk drinkers, which previous research suggested helps reduce alcohol-related problems over time. Targeted prevention methods also show promise, with a noticeable drop in alcohol use and related issues observed during follow-ups. Overall, these school-based programs have a strong record of helping teens cut down on risky drinking. ^{2 3 6 7 8}

Who Is on the Research Team?

Randi M Schuster, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10252488/

A Case for Expansion of a Peer Workforce in Child ... The rise in child and adolescent mental health concerns has led to the need for an expanded workforce to meet the needs of our nation's families ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2916744/

Evidence-Based Interventions for Preventing Substance Use ... The strongest intervention effects were observed among students exposed to at least 60% of the intervention; these students had significantly lower rates than ...

3. urban.org urban.org/sites/default/files/2022-07/Addressing%20Youth%20Substance%20Use%20through%20School%20Services%20and%20Supports.pdf

Addressing Youth Substance Use through School Services ... Studies examining changes in youth substance use during the pandemic have found mixed results, including decreases in alcohol use, increases in unhealthy use of ...

4. researchgate.net researchgate.net/publication/353992489_Trends_in_Substance_Use_and_Prevention_Education_Involvement_among_US_Adolescents_Receiving_Public_Assistance_New_Evidence

Trends in Substance Use and Prevention Education ... Results Compared to non-enrollees, PA program enrollees reported significantly lower rates of involvement in all prevention education settings, including parent ...

5. link.springer.com link.springer.com/article/10.1007/s12310-023-09580-3

Expanding School-Based Motivational Interviewing ... The most consistent conclusion among the studies reviewed was that paraprofessionals can be trained to deliver MI-based interventions, with 15 ...

6. withpower.com withpower.com/trial/school-interventions-for-adolescent-alcohol-use-1cddf

School Interventions for Adolescent Alcohol Use (OASIS Trial) What data supports the effectiveness of the treatment Expanded Paraprofessional Workforce, Indicated Prevention, Selective Prevention for adolescent alcohol use ...

7. bipartisanpolicy.org bipartisanpolicy.org/download/?file=/wp-content/uploads/2023/01/BPC_2022_Behavioral-Health-Integration-Report_RV3.pdf

Filling the Gaps in the Behavioral Health Workforce Congress should consider ways to study related outcome data to better understand BHSSs' impacts, perhaps to expand. BHSS reimbursement.

8. fadaa.org fadaa.org/page/Research_Reports

Research and Reports - Florida Alcohol and Drug Abuse ... This report focus on closing research gaps, supporting an MEB disorder prevention workforce, ensuring adequate data to support prevention and reporting.