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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075773
Recruitment Status : Completed
First Posted : September 3, 2019
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Mary M. Tomkins, University of Houston

Brief Summary:
This study is a trial of a brief alcohol intervention, a brief expressive writing intervention that incorporates religious identity.

Condition or disease Intervention/treatment Phase
Heavy Drinking Behavioral: Expressive Writing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
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
Official Title: Brief Religious Alcohol Intervention
Actual Study Start Date : September 4, 2019
Actual Primary Completion Date : August 11, 2020
Actual Study Completion Date : August 11, 2020

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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075773


Locations
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United States, Texas
University of Houston Psychology Department
Houston, Texas, United States, 77004
Sponsors and Collaborators
University of Houston
Investigators
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Principal Investigator: Mary M Tomkins, M.S. University of Houston
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Responsible Party: Mary M. Tomkins, Graduate Research Assistant, University of Houston
ClinicalTrials.gov Identifier: NCT04075773    
Other Study ID Numbers: STUDY00001734
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not have any plans at this time to share individual participant data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No