NCT04075773

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

September 4, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2020

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

August 28, 2019

Last Update Submit

August 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in the Timeline Follow-Back one month following the intervention

    Participants report number of drinks consumed each day over the last month.

    It will be assessed before the intervention and one month following the intervention.

Secondary Outcomes (1)

  • Chang in the Young Adult Alcohol Consequences Questionnaire one month following the intervention

    It will be assessed before the intervention and one month following the intervention.

Study Arms (2)

Religious Prompt

EXPERIMENTAL

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

Age Prompt

SHAM COMPARATOR

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

Interventions

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.

Age PromptReligious Prompt

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston Psychology Department

Houston, Texas, 77004, United States

Location

Study Officials

  • Mary M Tomkins, M.S.

    University of Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Research Assistant

Study Record Dates

First Submitted

August 28, 2019

First Posted

September 3, 2019

Study Start

September 4, 2019

Primary Completion

August 11, 2020

Study Completion

August 11, 2020

Last Updated

August 14, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

We do not have any plans at this time to share individual participant data with other researchers.

Locations