Back to resultsEvaluating Within-Person and Between-Person Effects Of A Personalized Normative Feedback Intervention On Drinking As They Are Moderated By Self-Determination
Primary Purpose
Alcohol Drinking
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol-Specific Personalized Normative Feedback
Social Media Personalized Normative Feedback
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Drinking
Eligibility Criteria
Inclusion Criteria:
- Student at the University of Houston
- Above 18 years of age
- Heavy drinker (more than 4 drinks [women] or 5 drinks [men] on a single occasion in the last 2.5 weeks and drinks, on average, at least once per week.
Sites / Locations
- University of Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Alcohol-Specific Personalized Normative Feedback
Social Media Personalized Normative Feedback
Arm Description
Participants will receive feedback about their average number of days on which alcohol was consumed, average drinks per occasion, and average number of drinks per week. This feedback will include the participant's averages reported at baseline, the participant's descriptive norm of others' averages (what they think others drank), and actual others' drinking. Feedback will be about other students at their university of the same sex.
Participants will receive feedback about their number of hours texting, on social media websites, and playing video games. This feedback will include the participant's averages reported at baseline, the participant's descriptive norm of others' averages (what they think others did), and actual others' behavior. Feedback will be about other students at their university of the same sex.
Outcomes
Primary Outcome Measures
Between-Person Self-Determination by PNF Interaction Predicting Consumption
A structural equation model will be fit with baseline consumption, self-determination, intervention condition, and the interaction between self-determination and condition predicting follow-up alcohol consumption. Consumption will be measured with the Alcohol Consumption Index, Quantity-Frequency-Peak Alcohol Use Index, and the Daily Drinking Questionnaire. These scales will be used as indicators of a single latent consumption variable. That latent consumption measure will be the outcome of interest.
Within-Person Self-Determination by PNF Interaction Predicting Consumption
A multilevel model will be fit with baseline consumption, daily self determination, intervention condition, and the interaction between condition and daily self-determination predicting daily alcohol consumption. Consumption will be measured as the number of drinks consumed the previous evening.
Secondary Outcome Measures
Between-Person Self-Determination by PNF Interaction Predicting Alcohol-Related Problems
A structural equation model will be fit with baseline consumption, alcohol-related problems, self-determination, intervention condition, and the interaction between self-determination and condition predicting follow-up alcohol-related problems. Alcohol-related problems will be measured with the Rutgers Alcohol Problems Index and the Young Adult Alcohol Consequences Questionnaire. Each of these problems measures will be split to form two indicators (for a total of four problems indicators) for an overall problems latent variable. This problems latent variable will then be used as the outcome of interest.
Within-Person Self-Determination by PNF Interaction Predicting Alcohol-Related Problems
A multilevel model will be fit with baseline consumption, daily self determination, intervention condition, and the interaction between condition and daily self-determination predicting daily alcohol alcohol-related problems. Alcohol-related problems will be measured with a checklist of non-overlapping items from the Rutgers Alcohol Problems Index and the Young Adult Alcohol Consequences Questionnaire. This combined checklist will be used to create the overall problems outcome of interest.
Full Information
NCT ID
NCT03583515
First Posted
June 1, 2018
Last Updated
April 1, 2020
Sponsor
University of Houston
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT03583515
Brief Title
Evaluating Within-Person and Between-Person Effects Of A Personalized Normative Feedback Intervention On Drinking As They Are Moderated By Self-Determination
Official Title
Self-Determination Theory as A Framework For Evaluating Within-Person Effects Of Personalized Normative Feedback On Drinking
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates within-person and between-person effects of a personalized normative feedback intervention and injunctive norms as they are altered by self-determination in heavy drinkers. Half of participants will receive personalized normative feedback and the other half will receive control feedback about media use habits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Half of participants will be randomly assigned to receive personalized normative feedback about their drinking. The other half will be randomly assigned to receive control feedback about social media use.
Masking
ParticipantInvestigator
Masking Description
Participants will be assigned to and receive feedback via the computer. Once they have received feedback a research assistant will print this feedback for them to take home. At this time, research assistants will become unblinded to condition, but will not administer any new procedures other than answering participant questions.
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alcohol-Specific Personalized Normative Feedback
Arm Type
Experimental
Arm Description
Participants will receive feedback about their average number of days on which alcohol was consumed, average drinks per occasion, and average number of drinks per week. This feedback will include the participant's averages reported at baseline, the participant's descriptive norm of others' averages (what they think others drank), and actual others' drinking. Feedback will be about other students at their university of the same sex.
Arm Title
Social Media Personalized Normative Feedback
Arm Type
Placebo Comparator
Arm Description
Participants will receive feedback about their number of hours texting, on social media websites, and playing video games. This feedback will include the participant's averages reported at baseline, the participant's descriptive norm of others' averages (what they think others did), and actual others' behavior. Feedback will be about other students at their university of the same sex.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol-Specific Personalized Normative Feedback
Intervention Description
Participants will receive personalized normative feedback about drinking.
Intervention Type
Behavioral
Intervention Name(s)
Social Media Personalized Normative Feedback
Intervention Description
Participants will receive personalized normative feedback about social media use.
Primary Outcome Measure Information:
Title
Between-Person Self-Determination by PNF Interaction Predicting Consumption
Description
A structural equation model will be fit with baseline consumption, self-determination, intervention condition, and the interaction between self-determination and condition predicting follow-up alcohol consumption. Consumption will be measured with the Alcohol Consumption Index, Quantity-Frequency-Peak Alcohol Use Index, and the Daily Drinking Questionnaire. These scales will be used as indicators of a single latent consumption variable. That latent consumption measure will be the outcome of interest.
Time Frame
2-4 Weeks
Title
Within-Person Self-Determination by PNF Interaction Predicting Consumption
Description
A multilevel model will be fit with baseline consumption, daily self determination, intervention condition, and the interaction between condition and daily self-determination predicting daily alcohol consumption. Consumption will be measured as the number of drinks consumed the previous evening.
Time Frame
17 Days
Secondary Outcome Measure Information:
Title
Between-Person Self-Determination by PNF Interaction Predicting Alcohol-Related Problems
Description
A structural equation model will be fit with baseline consumption, alcohol-related problems, self-determination, intervention condition, and the interaction between self-determination and condition predicting follow-up alcohol-related problems. Alcohol-related problems will be measured with the Rutgers Alcohol Problems Index and the Young Adult Alcohol Consequences Questionnaire. Each of these problems measures will be split to form two indicators (for a total of four problems indicators) for an overall problems latent variable. This problems latent variable will then be used as the outcome of interest.
Time Frame
2-4 Weeks
Title
Within-Person Self-Determination by PNF Interaction Predicting Alcohol-Related Problems
Description
A multilevel model will be fit with baseline consumption, daily self determination, intervention condition, and the interaction between condition and daily self-determination predicting daily alcohol alcohol-related problems. Alcohol-related problems will be measured with a checklist of non-overlapping items from the Rutgers Alcohol Problems Index and the Young Adult Alcohol Consequences Questionnaire. This combined checklist will be used to create the overall problems outcome of interest.
Time Frame
17 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Student at the University of Houston
Above 18 years of age
Heavy drinker (more than 4 drinks [women] or 5 drinks [men] on a single occasion in the last 2.5 weeks and drinks, on average, at least once per week.
Facility Information:
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study Protocol Informed Consent Form Analytic Code De-Identified Data
IPD Sharing Time Frame
Data will be available within a year of study completion.
IPD Sharing Access Criteria
Data will be available upon request.
Learn more about this trial
Evaluating Within-Person and Between-Person Effects Of A Personalized Normative Feedback Intervention On Drinking As They Are Moderated By Self-Determination
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