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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03864237
Other study ID # R21AA024771
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 2018
Est. completion date April 1, 2019

Study information

Verified date July 2019
Source Brown University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project aims to combat excessive perceived norms that contribute to high volume drinking by young adults, which adversely affects health and academic achievement. Campus-specific survey data will be used to craft accurate, pro-moderation campus norms, and deliver them to first-year students via daily text messages during the first semester of college. It is predicted that those receiving regular exposure to pro-moderation drinking norms will reduce their alcohol consumption and consequences, relative to students who receive non-alcohol-related control texts. This preliminary evaluation uses a novel method of delivering drinking norms and will lay the groundwork for future efforts to scale up this novel alcohol misuse prevention approach.


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.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 20 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Alcohol texts
A text message each day for 10 weeks, containing factual information about campus drinking norms.
Attention control
A text message each day for 10 weeks, containing "this day in history" facts.

Locations

Country Name City State
United States Brown University Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary drinks per week as assessed by the Daily Drinking Questionnaire 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
Primary alcohol-related consequences as assessed by the Brief Young Adult Alcohol Consequences Questionnaire 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 protective behavioral strategies as assessed by the Strategies Questionnaire 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
Secondary perceived descriptive drinking norms as assessed by the Drinking Norms Rating Form 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
Secondary perceived injunctive drinking norms as assessed by an adaptation of the Drinking Norms Rating Form 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
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