- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06543342
Bystander Intervention for Hazardous Drinking (DISH)
August 14, 2024 updated by: Nancy Barnett, Brown University
The objective of this treatment development grant is to create an innovative and efficacious alcohol intervention for emerging adults using features from three theoretically sound and empirically supported approaches.
A set of students will be engaged to serve as peer leaders to assist in reducing hazardous drinking behavior among their peers.
This new intervention, a Bystander Brief Motivational Intervention (BBMI) spans Stages 1A and 1B of the stage model of behavioral therapies research and will utilize qualitative methods, an open trial, and a small controlled pilot trial within the targeted college community.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The objective of this treatment development grant is to create an innovative and efficacious alcohol intervention for emerging adults using features from three theoretically sound and empirically supported approaches.
Established elements from Bystander Intervention (awareness of the problem, addressing pluralistic ignorance, skill building), Brief Motivational Intervention (client-centered foundation, corrective information about community norms, protective behavioral strategies) and Social Network Analysis (measuring network ties, identifying the influence of network members), will be integrated into a brief intervention that pays particular attention to the connectedness of residents in dormitory social networks.
Social network analytic methods will be used to assess the primary peer network (the college residence) and a set of individuals exposed to others drinking risks will be identified to receive the intervention.
This set of students will be engaged to serve as peer leaders to assist in reducing hazardous drinking behavior among their peers.
This new intervention, a Bystander Brief Motivational Intervention (BBMI) spans Stages 1A and 1B of the stage model of behavioral therapies research and will utilize qualitative methods, an open trial, and a small controlled pilot trial within the targeted college community.
Study Type
Interventional
Enrollment (Actual)
187
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Brown University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- First-year students in one of two residence halls. The subset of participants who were selected for intervention or control had to have been exposed to others who showed risk signs in the past month.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bystander Brief Motivational Intervention
Two 2-hour in person sessions focusing on identifying alcohol risks among peers, determining optimal bystander strategies to use, and identifying personal barriers to intervening.
|
Group-based interactive intervention, conducted in two sessions, including multiple tasks and exercises to identify different levels of risk behavior, different types of strategies, and practicing responding to different scenarios.
Personal goals for helping friends stay safe, and identifying whether intervention as a bystander was successful are included.
|
|
No Intervention: Assessment Control
Comparison group selected using the same criteria but receive no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exposure to the Hazardous Drinking of Others
Time Frame: 1 month and 3 months
|
Number of risk signs observed in peers -validated measure
|
1 month and 3 months
|
|
The Bystanders to Alcohol Risk Scale - Strategies
Time Frame: 1 month and 3 months
|
Number of strategies used to help others - validated measure
|
1 month and 3 months
|
|
Alcohol Bystander Readiness to Help
Time Frame: 1 month and 3 months
|
Self-perception of readiness to help others in different situations - measure validation underway
|
1 month and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2022
Primary Completion (Actual)
July 15, 2022
Study Completion (Actual)
July 15, 2022
Study Registration Dates
First Submitted
July 30, 2024
First Submitted That Met QC Criteria
August 4, 2024
First Posted (Actual)
August 9, 2024
Study Record Updates
Last Update Posted (Actual)
August 16, 2024
Last Update Submitted That Met QC Criteria
August 14, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- AA025456
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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