NCT03864237

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
6 years until next milestone

Results Posted

Study results publicly available

April 16, 2025

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

September 11, 2018

Results QC Date

September 21, 2020

Last Update Submit

April 14, 2025

Conditions

Keywords

alcohol abusecollege studentspreventive programstext messages

Outcome Measures

Primary Outcomes (2)

  • Drinks Per Week as Assessed by the Daily Drinking Questionnaire

    Sum of standard drinks consumed on each day in a typical week over the past 30 days; scores can be as low as zero but there is no upper limit as they are counts of drinks

    Assessed over prior 30 days at 3 month follow-up

  • 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

    Assessed over prior 30 days at 3 month follow-up

Secondary Outcomes (5)

  • Protective Behavioral Strategies as Assessed by the Strategies Questionnaire - Alternative Sub Scale

    Assessed over prior 30 days at 3 month follow-up

  • Perceived Descriptive Drinking Norms as Assessed by the Drinking Norms Rating Form

    Assessed over prior 30 days at 3 month follow-up

  • Perceived Injunctive Drinking Norms as Assessed by an Adaptation of the Drinking Norms Rating Form

    Assessed over prior 30 days at 3 month follow-up

  • Protective Behavioral Strategies as Assessed by the Strategies Questionnaire - Selective Avoidance Sub Scale

    Assessed over prior 30 days at 3 month follow-up

  • Protective Behavioral Strategies as Assessed by the Strategies Questionnaire - Strategies Sub Scale

    Assessed over prior 30 days at 3 month follow-up

Study Arms (2)

Alcohol texts

EXPERIMENTAL

Participants assigned to this arm will receive a text message each day for 10 weeks, containing factual information about campus drinking norms.

Behavioral: Alcohol texts

Attention control

PLACEBO COMPARATOR

Participants assigned to this arm will receive a text message each day for 10 weeks, containing "this day in history" facts.

Behavioral: Attention control

Interventions

Alcohol textsBEHAVIORAL

A text message each day for 10 weeks, containing factual information about campus drinking norms.

Alcohol texts

A text message each day for 10 weeks, containing "this day in history" facts.

Attention control

Eligibility Criteria

Age18 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \* currently engaged in alcohol treatment or in need of treatment (AUDIT score 20 or higher)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Carey KB, Merrill JE, Boyle HK, Barnett NP. Correcting exaggerated drinking norms with a mobile message delivery system: Selective prevention with heavy-drinking first-year college students. Psychol Addict Behav. 2020 May;34(3):454-464. doi: 10.1037/adb0000566. Epub 2020 Mar 2.

MeSH Terms

Conditions

Alcohol Drinking in CollegeAlcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol DrinkingDrinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Kate B. Carey
Organization
Brown University School of Public Health

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2018

First Posted

March 6, 2019

Study Start

September 5, 2018

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

April 16, 2025

Results First Posted

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

After all data have been collected and results of the study have been published, de-identified data will be made available to other qualified investigators upon request. The request will be evaluated by the investigators to ensure that it meets reasonable expectations of scientific integrity.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
within one year of study completion, for up to 3 years
Access Criteria
to be determined

Locations