NCT04105725

Brief Summary

The purpose of this study is to evaluate a text-message delivered approach for improving college adjustment and experience and reducing risky alcohol use in young adult college students. The study compares a text-message delivered brief motivational intervention for reducing alcohol use and increasing engagement in alcohol-free activities, to text-message delivered alcohol and nutrition education sessions. The investigators predict that individuals who receive the brief motivational intervention will report less alcohol use and fewer related problems 3 months following the intervention compared to those who receive the education sessions. The investigators also expect that these individuals will report greater engagement in alcohol-free activities compared to those who receive the education sessions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration 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 30, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

June 14, 2022

Completed
Last Updated

June 14, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

June 28, 2019

Results QC Date

May 16, 2022

Last Update Submit

May 16, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Daily Drinking Questionnaire

    Change in past-month typical weekly alcohol use

    Baseline, 3-month follow-up

  • Heavy Episodic (Binge) Drinking

    Change in past-month heavy drinking episodes

    Baseline, 3-month follow-up

  • Brief Young Adult Alcohol Consequences Questionnaire

    Change in past-month alcohol-related problems

    Baseline, 3-month follow-up

Secondary Outcomes (4)

  • Adolescent Reinforcement Survey Schedule - Substance Use Version

    Baseline, 5-week follow-up, 3-month follow-up

  • Monetary Choice Questionnaire

    Baseline, 1-week follow-up, 2-week follow-up, 3-week follow-up, 4-week follow-up, 5-week follow-up, 3-month follow-up

  • Alcohol Purchase Task

    Baseline, 1-week follow-up, 2-week follow-up, 3-week follow-up, 4-week follow-up, 5-week follow-up, 3-month follow-up

  • Time Allocation

    Baseline, 1-week follow-up, 2-week follow-up, 3-week follow-up, 4-week follow-up, 5-week follow-up, 3-month follow-up

Study Arms (2)

BMI+Substance-Free Activity Session

EXPERIMENTAL

Two 50-minute text messaging sessions that discuss alcohol use and experiences related to alcohol use, as well as the individual's college, career, and personal goals. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that return to the individual's goals and progress.

Behavioral: Brief Motivational Intervention+Substance-Free Activity Session

Alcohol + Nutrition Education Session

ACTIVE COMPARATOR

Two 50-minute text messaging sessions the provide information on alcohol and nutrition. Additionally, there are 4 weeks of 20-30-minute booster text messaging sessions (once a week) that provide additional information and review previous information about alcohol use and nutrition.

Other: Alcohol + Nutrition Education Session

Interventions

A dialogue with the individual of their own experiences with alcohol use and related problems, as well as academic/career goals and personal interests.

Also known as: BMI+SFAS, mBMI+SFAS, mobile BMI+SFAS
BMI+Substance-Free Activity Session

Education on alcohol, alcohol metabolism in the body, and alcohol overdose, as well as education on food groups and recommendations for a balanced diet.

Also known as: A+NE, mA+NE, mobile A+NE
Alcohol + Nutrition Education Session

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Full-time college student
  • Employed \< or = 30 hours per week
  • Report at least 2 past-month heavy drinking episodes (4 or more standard drinks for women and 5 or more standard drinks for men in one sitting/occasion)
  • Own or have access to a smartphone, tablet, laptop, or desktop computer with Internet access
  • Speak, read, and write in English

You may not qualify if:

  • Currently in treatment for a substance use disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Memphis

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Conditions

Binge DrinkingAlcohol Drinking in CollegeDrinking BehaviorBehavior

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersAlcohol DrinkingMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Dr. Kathryn Gex
Organization
Medical University of South Carolina

Study Officials

  • Kathryn E Soltis, M.S.

    The University of Memphis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2019

First Posted

September 26, 2019

Study Start

September 30, 2018

Primary Completion

April 10, 2020

Study Completion

July 31, 2020

Last Updated

June 14, 2022

Results First Posted

June 14, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

De-identified participant data will be made available for sharing with general research community 2 years after the grant end date on the Notice of Award (September 29, 2020), in order to provide study investigators with protected time to publish from the study data.

Time Frame
De-identified data will be made available September 30, 2022, which is two years after the project end date specified on the Notice of Award.
Access Criteria
De-identified data will be shared with qualified researchers with relevant expertise upon request for the purposes of conducting review papers or meta/integrated analyses.

Locations