- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04639882
Motivating Recruitment and Efficacy in Normative Feedback Interventions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77204
- University of Houston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Reporting one or more heavy drinking occasions (4/5 drinks on one drinking occasion for women/men) in the previous month Reporting one or more negative alcohol-related consequence in the previous month Being between 18 and 26 years of age Being a registered University of Houston student Providing consent to participate in the study
Exclusion Criteria:
Not meeting any of the inclusion criteria Unwillingness to participate Failure to provide consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control-Remote-$0
In this condition, Participants:
|
Information presenting perceived and actual drinking norms.
|
Experimental: Control-Remote-$30
In this condition, Participants:
|
Information presenting perceived and actual drinking norms.
|
Experimental: Control-InPerson-$0
In this condition, Participants:
|
Information presenting perceived and actual drinking norms.
|
Experimental: Control-InPerson-$30
In this condition, Participants:
|
Information presenting perceived and actual drinking norms.
|
Experimental: PNF-Remote-$0
In this condition, Participants:
|
Information presenting perceived and actual drinking norms.
|
Experimental: PNF-Remote-$30
In this condition, Participants:
|
Information presenting perceived and actual drinking norms.
|
Experimental: PNF-Inperson-$0
In this condition, Participants:
|
Information presenting perceived and actual drinking norms.
|
Experimental: PNF-Inperson-$30
In this condition, Participants:
|
Information presenting perceived and actual drinking norms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of drinks in past month - Timeline Follow-back (TLFB)
Time Frame: 1 month
|
This measure asks participants to indicate how many drinks they consumed on each day of the previous month.
Scores are summed.
|
1 month
|
Number of drinks on a typical week - Daily Drinking Questionnaire (DDQ)
Time Frame: 3 months
|
Participants are asked how many drinks they typically drink on each day of a typical week.
These values are summed to create a drinks per week score.
From Collins, Parks, and Marlatt (1985).
|
3 months
|
Number of peak drinks consumed
Time Frame: One month
|
Participants are asked to indicate the maximum number of drinks consumed on one occasion.
|
One month
|
Alcohol-related consequences: Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)
Time Frame: One month
|
A measure of 27 alcohol consequences.
Participants indicate whether they have experienced the consequence or not and responses are summed to create a total score.
|
One month
|
Alcohol-related consequences: Rutgers Alcohol Problems Index (RAPI)
Time Frame: 3 months
|
A measure of alcohol consequences.
Participants indicate the frequency with which they have experienced each consequence; responses are summed to create a total score.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perception of number of drinks a typical college student drinks
Time Frame: 3 months
|
The DDQ (Outcome 2) was modified to ask participants how often they think the typical college student of their same sex drinks in a typical week.
Responses are again summed to create a total score.
This measure is posited as a mediator of intervention efficacy on changes in drinking.
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R21AA022369 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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