- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04075773
Brief Religious Alcohol Intervention (BRAI)
August 12, 2020 updated by: Mary M. Tomkins, University of Houston
This study is a trial of a brief alcohol intervention, a brief expressive writing intervention that incorporates religious identity.
Study Overview
Study Type
Interventional
Enrollment (Actual)
203
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
-
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Texas
-
Houston, Texas, United States, 77004
- University of Houston Psychology Department
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-
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 29 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 to 29 years old
- Have had a binge episode (4/5 drinks on one occasion for women/men) at least once in the past month
- UH students
Exclusion Criteria:
- Participants who are currently enrolled in treatment for alcohol or other substances
- Participants who have been diagnosed with and/or treated for verbal learning disabilities
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Religious Prompt
Participants will be provided a writing prompt that describes their self-reported drinking, then asks them to write for 5 to 10 minutes about how that drinking is associated with their self-reported religious identity.
After completing that writing assignment, participants will be shown their response, and asked to spend 5 to 10 minutes describing how their drinking behaviors in the next month might change.
|
The participants are asked to write for a period of time about specific concepts so that they think carefully and cognitively process the information they are generating.
|
Sham Comparator: Age Prompt
Participants will be provided a writing prompt that describes their self-reported drinking, then asks them to write for 5 to 10 minutes about how that drinking is associated with their self-reported age.
After completing that writing assignment, participants will be shown their response, and asked to spend 5 to 10 minutes describing how their drinking behaviors in the next month might change.
|
The participants are asked to write for a period of time about specific concepts so that they think carefully and cognitively process the information they are generating.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Timeline Follow-Back one month following the intervention
Time Frame: It will be assessed before the intervention and one month following the intervention.
|
Participants report number of drinks consumed each day over the last month.
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It will be assessed before the intervention and one month following the intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chang in the Young Adult Alcohol Consequences Questionnaire one month following the intervention
Time Frame: It will be assessed before the intervention and one month following the intervention.
|
Participants respond to a list of common consequences of alcohol use indicating whether or not they have experienced them.
The scale name is the "Young Adult Alcohol Consequences Questionnaire" (Read, Kahler, Strong, & Colder, 2006).
The construct of interest measured by this scale is the alcohol problems experienced by the participant.
The total score is used, and the range for the total score is 0 to 48.
|
It will be assessed before the intervention and one month following the intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mary M Tomkins, M.S., University of Houston
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 4, 2019
Primary Completion (Actual)
August 11, 2020
Study Completion (Actual)
August 11, 2020
Study Registration Dates
First Submitted
August 28, 2019
First Submitted That Met QC Criteria
August 29, 2019
First Posted (Actual)
September 3, 2019
Study Record Updates
Last Update Posted (Actual)
August 14, 2020
Last Update Submitted That Met QC Criteria
August 12, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00001734
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We do not have any plans at this time to share individual participant data with other researchers.
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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