- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04147520
Reducing Hazardous Alcohol Use in Social Networks Using Targeted Intervention: 21 Rising
July 29, 2021 updated by: Brown University
The primary goal of this study is to determine whether change in alcohol use among college students can be transmitted through social network ties to other members in the network.
Members of one college class at a northeastern university will be enrolled in a longitudinal study in which they will provide self-reported behavioral information and information about their social ties to others in their college class.
A subset of heavy drinking participants will be asked to meet in person to complete an interview about their alcohol use - called a Brief Motivational Interview.
There is evidence that this sort of interview can reduce harmful alcohol use.
The investigators expect that following the Brief Motivational Interview others in their friendship clusters will show reduced harm associated with alcohol use as well.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1475
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Must be a member of the class of 2021 or 2021.5 at the site university
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 |
---|---|
Active Comparator: Brief Motivational Interview
Single-session in person conversation focusing on risks associated with alcohol use.
|
Single (60 min) session discussion of alcohol use and associated experiences.
|
No Intervention: Natural History Control
No contact.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol use
Time Frame: At each follow up, measure average drinks per week in the past 30 days
|
Average number of drinks per week in the past 30 days
|
At each follow up, measure average drinks per week in the past 30 days
|
Average number of alcohol consequences in the past 30 days
Time Frame: At each follow up, measure count of alcohol consequences in the past 30 days
|
Count of alcohol consequences in the past 30 days
|
At each follow up, measure count of alcohol consequences in the past 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nancy Barnett, Ph.D., Brown University
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)
October 7, 2019
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
October 23, 2019
First Submitted That Met QC Criteria
October 30, 2019
First Posted (Actual)
November 1, 2019
Study Record Updates
Last Update Posted (Actual)
August 2, 2021
Last Update Submitted That Met QC Criteria
July 29, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1810002247
- 2R01AA023522 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There is concern that with information in the dataset, including social ties, individuals could be re-identified.
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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