NCT05065918

Brief Summary

This study is designed to pilot a text message (TM) delivered behavior change intervention to decrease binge drinking and to increase use of sexual violence (SV) harm reduction strategies among college students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

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

First Submitted

Initial submission to the registry

September 16, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 4, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 17, 2024

Completed
Last Updated

October 17, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

September 16, 2021

Results QC Date

August 5, 2024

Last Update Submit

October 14, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Number of Drinking Days Per Month

    as measured using a 30-day timeline follow-back (TLFB)

    3 month follow up

  • Number of Drinking Days Per Month

    as measured using a 30-day timeline follow-back (TLFB)

    6 month follow up

  • Number of Binge Drinking Days Per Month

    as measured using a 30-day timeline follow-back (TLFB)

    3 month follow up

  • Number of Binge Drinking Days Per Month

    as measured using a 30-day timeline follow-back (TLFB)

    6 month follow up

  • Use of Sexual Violence Harm Reduction Strategies

    Use of sexual violence harm reduction strategies assessed with an 11 item scale used by the American College Health Association's National College Health Survey of Protective Behavioral Strategies. Participants report on how often when drinking/socializing in the past 3 months they used each of the specific behaviors on a 5-point Likert scale ranging from (1 = never, 5 = always; theoretical range 11-55) with higher scores indicating higher frequency use of harm reduction strategies.

    3 month follow up

  • Use of Sexual Violence Harm Reduction Strategies

    Use of sexual violence harm reduction strategies assessed with an 11 item scale used by the American College Health Association's National College Health Survey of Protective Behavioral Strategies. Participants report on how often when drinking/socializing in the past 3 months they used each of the specific behaviors on a 5-point Likert scale ranging from (1 = never, 5 = always; theoretical range 11-55) with higher scores indicating higher frequency use of harm reduction strategies.

    6 month follow up

Secondary Outcomes (4)

  • Knowledge of Sexual Violence and Alcohol Risk

    3 month follow up

  • Knowledge of Sexual Violence and Alcohol Risk

    6 month follow up

  • Self-efficacy to Obtain Sexual Consent.

    3 month follow up

  • Self-efficacy to Obtain Sexual Consent.

    6 month follow up

Study Arms (2)

Control - alcohol use reduction content

ACTIVE COMPARATOR

Alcohol use reduction content

Behavioral: alcohol use reduction content

Intervention - sexual violence and alcohol use harm reduction content

EXPERIMENTAL

sexual violence and alcohol use harm reduction content

Behavioral: sexual violence and alcohol use harm reduction text message content

Interventions

The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.

Intervention - sexual violence and alcohol use harm reduction content

The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback).

Control - alcohol use reduction content

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-24 years,
  • current college or university student,
  • owns a mobile phone with internet access and unlimited text message plan,
  • reports binge drinking in the past 30 days \[\>3 drinks for women, \>4 drinks men in one sitting\]
  • Able to complete participation in English.
  • To evaluate messages tailored to prior SV victimization, approximately 50% of the sample will also be purposively recruited for a baseline history of SV.

You may not qualify if:

  • Under 18 years old, over 24 years old
  • Not currently enrolled in college
  • Does not own a mobile phone with internet access and unlimited data plan
  • Does not report binge drinking in the past 30 day
  • Unable to complete study participation in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Jocelyn Anderson
Organization
The University of Arkansas for Medical Sciences

Study Officials

  • Jocelyn Anderson

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2021

First Posted

October 4, 2021

Study Start

November 4, 2021

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

October 17, 2024

Results First Posted

October 17, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations