- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06570720
Alcohol-focused Support of Survivors in Sororities Training (ASSIST) - Pilot
February 14, 2025 updated by: Anna Jaffe, University of Washington
ASSIST Study: Pilot Cluster Randomized Trial
The goal of this clinical trial is to conduct a preliminary evaluation of the ASSIST (Alcohol-focused Support of Survivors in Sororities Training) intervention in sorority chapters.
ASSIST is a newly developed web-based intervention to increase peer support of sexual assault survivors and reduce encouragement of drinking to cope within social networks of sororities.
To test whether the intervention is feasible and shows preliminary signs of working, a pilot cluster randomized trial will be conducted.
Sorority chapters will be recruited and randomly assigned to an intervention condition or an assessment-only condition.
Individuals within each sorority will be recruited and complete a norm documentation survey.
One month later, participants will complete a baseline survey, and if assigned to the intervention condition, will then receive the web-based ASSIST intervention, which will include normative feedback on values and drinking, psychoeducation about sexual assault recovery and the role of alcohol, and skills training in behaviors that can be used to support survivors without or while moderating heavy drinking.
All participants will complete online follow-up surveys at 1-, 3-, and 6-months post-intervention.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
600
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 Contact
- Name: Anna Jaffe, PhD
- Phone Number: 206-221-6692
- Email: ajaffe2@uw.edu
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- Recruiting
- University of Washington
-
Contact:
- Anna E Jaffe, PhD
- Phone Number: 2062210355
- Email: ajaffe2@uw.edu
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Chapter-Level Inclusion Criteria:
- Greek organization of undergraduate women recognized by the Office of Fraternity & Sorority Life with a physical house for chapter members
- At least 80 active members
Individual-Level Inclusion Criteria:
- Aged 18 years or older
- Current student
- Active member in a participating sorority chapter
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ASSIST
Participants in this arm will receive online survey assessments as well as the behavioral intervention, ASSIST.
|
A web-based intervention that includes sorority and individual values, personalized normative feedback (adapted to address sexual assault, support, and acceptability of encouraging peer drinking), psychoeducation on sexual assault and alcohol, and skills training in behaviors to support sexual assault survivors without heavy drinking.
|
|
No Intervention: Assessment-Only
Participants in this arm will only receive online survey assessments.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived helpfulness
Time Frame: Immediate post-intervention
|
Participants will rate the helpfulness of information provided.
Range: 1 to 5. Higher scores represent greater helpfulness.
|
Immediate post-intervention
|
|
Social Support
Time Frame: Baseline; 1-, 3-, and 6-month follow-up
|
On the Multidimensional Scale of Perceived Social Support (MSPSS), participants will rate the support of family, friends, and a significant other.
A mean score will be computed.
Range: 1 to 7. Higher scores represent more social support.
|
Baseline; 1-, 3-, and 6-month follow-up
|
|
Alcohol use
Time Frame: Baseline; 1-, 3-, and 6-month follow-up
|
On the Daily Drinking Questionnaire (DDQ), participants will report how many standard drinks (0 to 25+) they consumed each day for a typical week in the past month.
Total number of drinks per week will be calculated.
Range: 0 to 175.
Higher scores represent more alcohol use.
|
Baseline; 1-, 3-, and 6-month follow-up
|
|
Alcohol-related consequences
Time Frame: Baseline; 1-, 3-, and 6-month follow-up
|
On the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ), participants will indicate whether they have experienced each of 24 negative consequences of alcohol use in the past month.
A count of number of consequences experienced will be calculated.
Range: 0-24.
Higher scores represent more consequences experienced.
|
Baseline; 1-, 3-, and 6-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anna Jaffe, University of Washington
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 18, 2024
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
August 14, 2024
First Submitted That Met QC Criteria
August 21, 2024
First Posted (Actual)
August 26, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 14, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00018662
- K08AA028546 (U.S. NIH Grant/Contract)
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
product manufactured in and exported from the U.S.
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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