Evaluating Within-Person and Between-Person Effects Of A Personalized Normative Feedback Intervention On Drinking As They Are Moderated By Self-Determination
Self-Determination Theory as A Framework For Evaluating Within-Person Effects Of Personalized Normative Feedback On Drinking
1 other identifier
interventional
136
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2018
CompletedFirst Submitted
Initial submission to the registry
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
July 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedApril 2, 2020
April 1, 2020
1.4 years
June 1, 2018
April 1, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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.
2-4 Weeks
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.
17 Days
Secondary Outcomes (2)
Between-Person Self-Determination by PNF Interaction Predicting Alcohol-Related Problems
2-4 Weeks
Within-Person Self-Determination by PNF Interaction Predicting Alcohol-Related Problems
17 Days
Study Arms (2)
Alcohol-Specific Personalized Normative Feedback
EXPERIMENTALParticipants 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.
Social Media Personalized Normative Feedback
PLACEBO COMPARATORParticipants 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.
Interventions
Participants will receive personalized normative feedback about drinking.
Participants will receive personalized normative feedback about social media use.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Houston
Houston, Texas, 77204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 1, 2018
First Posted
July 11, 2018
Study Start
April 25, 2018
Primary Completion
August 31, 2019
Study Completion
August 31, 2019
Last Updated
April 2, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, ANALYTIC CODE
- Time Frame
- Data will be available within a year of study completion.
- Access Criteria
- Data will be available upon request.
Study Protocol Informed Consent Form Analytic Code De-Identified Data