NCT05145868

Brief Summary

Acute alcohol intoxication is a robust predictor of intimate partner violence (IPV) perpetration for young adult men and women; therefore, interventions delivered proximally to drinking episodes - a period of high risk - are needed to reduce alcohol-facilitated IPV. This project seeks to improve public health by delivering a just-in-time text messaging intervention proximally to drinking episodes and evaluating the impact of the intervention on alcohol-facilitated IPV in a sample of at-risk young adult men and women. Additionally, through an innovative design this project is poised to answer these important questions: whether receiving a message, when, for whom, what type, and under what conditions this just-in-time messaging intervention leads to reductions in alcohol use and IPV perpetration.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 3, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

3.2 years

First QC Date

November 11, 2021

Last Update Submit

March 12, 2025

Conditions

Alcohol DrinkingAggressionEmotion Regulation

Outcome Measures

Primary Outcomes (8)

  • Alcohol Use

    Drinking Quantity (number of drinks consumed)

    30 days

  • Alcohol Use

    Drinking Quantity (number of drinks consumed)

    1-month follow-up

  • Alcohol Use

    Drinking Quantity (number of drinks consumed)

    3-month follow-up

  • Alcohol Use

    Drinking Quantity (number of drinks consumed)

    6-month follow-up

  • Intimate Partner Violence

    Occurrence (yes/no) of psychological or physical Aggression against an intimate partner

    30 days

  • Intimate Partner Violence

    Frequency of Psychological or Physical Aggression against an intimate partner

    1-month follow-up

  • Intimate Partner Violence

    Frequency of Psychological or Physical Aggression against an intimate partner

    3-month follow-up

  • Intimate Partner Violence

    Frequency of Psychological or Physical Aggression against an intimate partner

    6-month follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in this arm will receive the RELATE intervention.

Behavioral: Alcohol Skills and Emotion Regulation Intervention

Attention Control

ACTIVE COMPARATOR

Participants in this arm will receive supportive control messages.

Other: Attention Control

Interventions

Alcohol Skills and Emotion Regulation InterventionBEHAVIORAL

The text-based intervention will provide alcohol reduction strategies and emotion regulation skills.

Intervention
Attention ControlOTHER

Text-messages will be sent that include no intervention content to serve as an attention control

Attention Control

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Consumed alcohol an average of 2 times per week in last 3 months
  • At least two instances of heavy episodic drinking in last month
  • Currently in a romantic relationship
  • History of IPV perpetration within last 3 months
  • Willing to provide cell phone number and carrier and receive text messages for 30 days

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30303, United States

RECRUITING

MeSH Terms

Conditions

Alcohol DrinkingAggressionEmotional Regulation

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAberrant Motor Behavior in DementiaBehavioral SymptomsSocial BehaviorSelf-Control

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Cynthia Stappenbeck, PhD

    Georgia State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Stappenbeck, PhD

CONTACT

404-413-6321cstappenbeck@gsu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 11, 2021

First Posted

December 6, 2021

Study Start

January 3, 2023

Primary Completion

April 1, 2026

Study Completion

April 30, 2026

Last Updated

March 14, 2025

Record last verified: 2025-03

Locations

US(1)