- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05620849
Young Adult Education on Alcohol & Health (YEAH)
December 5, 2024 updated by: Jessica Blayney, University of Washington
A Technology-based Intervention for Alcohol-related Sexual Risk Behaviors in Young Women
The goal of this clinical trial is to test the effectiveness of our brief online program when compared to those who don't complete the program at all.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
A total of 300 participants will complete this 6 month study.
The study will include a background survey, 5 week monitoring period where participants either complete the brief online program with check-in surveys or check-in surveys only, and follow-up surveys 1, 3, and 6 months later.
Study Type
Interventional
Enrollment (Estimated)
300
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: Jessica A Blayney, PhD
- Phone Number: 2068192946
- Email: jab24@uw.edu
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- Recruiting
- University of Washington
-
Contact:
- Jessica Blayney, PhD
- Phone Number: 206-678-5118
-
-
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 to 24 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Assessed as part of screening procedures
Exclusion Criteria:
- Do not want to participate
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: Intervention only
This group will complete 4 weeks of the brief online program along with 5 weeks of check-in surveys.
|
The online program is 4 weeks and focused on topics such as alcohol and sexual health
|
|
No Intervention: Assessment only
This group will complete 5 weeks of check-in surveys.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Drinking before sex (frequency)
Time Frame: Follow up (1 month, 3 month, 6 months)
|
Using items from the Sexual Health Questionnaire, the investigators will assess the frequency of drinking before sex.
|
Follow up (1 month, 3 month, 6 months)
|
|
Drinking before sex (quantity)
Time Frame: Follow up (1 month, 3 month, 6 months)
|
Using items from the Sexual Health Questionnaire, the investigators will assess the number of drinks consumed before sex.
|
Follow up (1 month, 3 month, 6 months)
|
|
Condomless sex
Time Frame: Follow up (1 month, 3 month, 6 months)
|
Using items from the Sexual Health Questionnaire, the investigators will assess the frequency of condom use during penetrative sex.
|
Follow up (1 month, 3 month, 6 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Drinking before sex
Time Frame: End of the 5 week study
|
Using items from the Sexual Health Questionnaire, we will assess the quantity and frequency of drinking before sex.
|
End of the 5 week study
|
|
Number of sexual partners
Time Frame: End of the 5 week study
|
Using items from the Sexual Health Questionnaire, we will assess number of sexual partners (casual, committed).
|
End of the 5 week study
|
|
Condomless sex
Time Frame: End of the 5 week study
|
Using items from the Sexual Health Questionnaire, we will assess the frequency of condom use during penetrative sex.
|
End of the 5 week study
|
|
Alcohol use
Time Frame: End of the 5 week study
|
Using the Daily Drinking Questionnaire, we will assess typical drinking quantity and frequency.
|
End of the 5 week study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jessica Blayney, PhD, 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)
September 15, 2023
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
January 31, 2026
Study Registration Dates
First Submitted
November 1, 2022
First Submitted That Met QC Criteria
November 10, 2022
First Posted (Actual)
November 17, 2022
Study Record Updates
Last Update Posted (Estimated)
December 9, 2024
Last Update Submitted That Met QC Criteria
December 5, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00010940
- 1K99AA028777-01 (U.S. NIH Grant/Contract)
- 4R00AA028777 (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
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.