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Brief Religious Alcohol Intervention (BRAI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075773
Recruitment Status : Recruiting
First Posted : September 3, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Mary M. Tomkins, University of Houston

Tracking Information
First Submitted Date  ICMJE August 28, 2019
First Posted Date  ICMJE September 3, 2019
Last Update Posted Date October 10, 2019
Actual Study Start Date  ICMJE September 4, 2019
Estimated Primary Completion Date April 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brief Religious Alcohol Intervention
Official Title  ICMJE Brief Religious Alcohol Intervention
Brief Summary This study is a trial of a brief alcohol intervention, a brief expressive writing intervention that incorporates religious identity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomized to either an intervention condition, where they will write about how their drinking relates to their religious identity, or to a control condition, where they will write about how their drinking relates to their age.
Masking: Double (Participant, Care Provider)
Masking Description:
Participants will not be made aware of the purpose of the study. Research assistants, who interact with the participants, will not be made aware of which writing prompt any given participant will receive.
Primary Purpose: Treatment
Condition  ICMJE Heavy Drinking
Intervention  ICMJE Behavioral: Expressive Writing
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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Expressive Writing
  • 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.
    Intervention: Behavioral: Expressive Writing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 29, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 15, 2020
Estimated Primary Completion Date April 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 29 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mary M Tomkins, M.S. 7137434297 mmt07b@acu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04075773
Other Study ID Numbers  ICMJE STUDY00001734
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: We do not have any plans at this time to share individual participant data with other researchers.
Responsible Party Mary M. Tomkins, University of Houston
Study Sponsor  ICMJE University of Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary M Tomkins, M.S. University of Houston
PRS Account University of Houston
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP