- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03864237
Text-based Alcohol Prevention for First Year College Students
Correcting Exaggerated Drinking Norms With a Mobile Message Delivery System
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Using mobile technology that most students already have in their pockets, this study evaluates a novel use of SMS text messages to change campus drinking norms. The aim is to correct exaggerated perceptions of drinking norms, and thereby reduce excessive drinking, by delivering daily text messages representing accurate, campus-specific, pro-moderation descriptive norms (what others do) and injunctive norms (what others approve of). It is predicted that with repeated exposure over time, this information will compete with other sources of normative information to which students are exposed during their first year of college. This exploratory study is designed to develop and refine message content and to pilot test the delivery methods.
First year students (N=120) who are underage but report risky drinking (>4/day or >14/week for men; >3/day or >7/week for women) will be randomly assigned to two conditions differing by text content: alcohol norms or attention control. All will receive daily text messages throughout 10 weeks in the first semester of college. Process measures, 3-month post-test, and 3-month follow-up assessments will yield feasibility, acceptability, and preliminary outcome data to inform future larger scale randomized trials. Specifically, baseline, post-test, and 3-month follow-up assessments will allow us to test the hypotheses that the corrective norms intervention will reduce (a) perceived descriptive and injunctive norms, (b) drinking behavior (including high-volume drinking and risky consumption practices), and (c) alcohol-related consequences, and increase (d) protective behavioral strategies, relative to the control condition.
At the end of this project the investigative team will have gathered data on both descriptive and injunctive norms on a range of drinking behaviors to identify topics in need of corrective normative feedback, refined the structure and content of the text messages, and pilot tested the text-delivered intervention in a small scale RCT. The proposed research will provide evidence of feasibility and efficacy of a text-based alcohol norms intervention for reducing excessive drinking among first-year students.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Brown University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-20 years of age
- enrolled as a first-year undergraduate student
- past month risky drinking
- possession of a mobile phone with text message capacity
- use text messaging at least weekly
Exclusion Criteria:
* currently engaged in alcohol treatment or in need of treatment (AUDIT score 20 or higher)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alcohol texts
Participants assigned to this arm will receive a text message each day for 10 weeks, containing factual information about campus drinking norms.
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A text message each day for 10 weeks, containing factual information about campus drinking norms.
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Placebo Comparator: Attention control
Participants assigned to this arm will receive a text message each day for 10 weeks, containing "this day in history" facts.
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A text message each day for 10 weeks, containing "this day in history" facts.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
drinks per week as assessed by the Daily Drinking Questionnaire
Time Frame: change from baseline to 3 month follow-up
|
Number of standard drinks consumed in a typical week over the past 30 days; scores can be as low as zero but have not upper limit as they are counts of drinks
|
change from baseline to 3 month follow-up
|
alcohol-related consequences as assessed by the Brief Young Adult Alcohol Consequences Questionnaire
Time Frame: change from baseline to 3 month follow-up
|
The total number of alcohol-related consequences experienced over the past 30 days is measured by the Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ), which is a checklist of 24 items; scores range from 0-24; higher numbers of items endorsed indicate more problems experienced in the past 30 days
|
change from baseline to 3 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
protective behavioral strategies as assessed by the Strategies Questionnaire
Time Frame: change from baseline to 3 month follow-up
|
self-reported frequency of using strategies to moderate drinking as reported on the Strategy Questionnaire; the Strategy Questionnaire has 3 sub scales including Selective Avoidance (0-70), Strategies While Drinking (0-100), and Alternatives to Drinking (0-40) and higher sub scale scores indicate more frequent use of those strategies
|
change from baseline to 3 month follow-up
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perceived descriptive drinking norms as assessed by the Drinking Norms Rating Form
Time Frame: change from baseline to 3 month follow-up
|
perceived descriptive norms are assessed using a variation on the Drinking Norms Rating Form, which asks respondents to estimate the number of standard drinks consumed by other students on campus for each day in a typical week in the past 30 days; daily estimates are summed to yield perceived number of drinks per week for student peers; range of scores can go from zero to no upper limit
|
change from baseline to 3 month follow-up
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perceived injunctive drinking norms as assessed by an adaptation of the Drinking Norms Rating Form
Time Frame: change from baseline to 3 month follow-up
|
perceived injunctive norms are assessed using the Krieger et al. (2016) adaptation of the Drinking Norms Rating Form, which asks respondents to estimate the how many standard drinks is deemed acceptable by other students on campus to drink on each day in a typical week in the past 30 days; estimates are summed to yield number of drinks per week approved of by student peers; the scores can range from zero to no upper limit
|
change from baseline to 3 month follow-up
|
Collaborators and Investigators
Sponsor
Publications and helpful links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AA024771 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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