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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking
• Intervention / Treatment: Behavioral: Alcohol-Specific Personalized Normative Feedback; Behavioral: Social Media Personalized Normative Feedback

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • University of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Alcohol-Specific Personalized Normative Feedback; 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.	Behavioral: Alcohol-Specific Personalized Normative Feedback; Participants will receive personalized normative feedback about drinking.
PLACEBO_COMPARATOR: Social Media Personalized Normative Feedback; 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.	Behavioral: Social Media Personalized Normative Feedback; Participants will receive personalized normative feedback about social media use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2-4 Weeks
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.	17 Days

Collaborators and Investigators

• Sponsor: University of Houston
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2018
• Primary Completion (ACTUAL): August 31, 2019
• Study Completion (ACTUAL): August 31, 2019

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (ACTUAL): July 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 2, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 1F31AA026195-01A1 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No