Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence

NCT ID: NCT04625465

Last Updated: 2025-07-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

474 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-12

Study Completion Date

2023-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

We will recruit sexual and gender minority couples to complete 56 days of daily surveys in order to evaluate (1) the impact of COVID-19 stress and sexual and gender minority stress on heavy episodic drinking and intimate partner violence (IPV) perpetration, and (2) a brief, mobile-phone delivered text messaging intervention to mitigate the effects of these stressors. This project has high potential to inform how pandemic stress contributes to etiological models of alcohol-related IPV perpetration in sexual and gender minority couples and inform a culturally-sensitive, low burden, and easy to disseminate intervention to mitigate these effects critical during a pandemic when access to care is limited.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Consumption Violence, Domestic Stress, Psychological Aggression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will be enrolled into a measurement burst daily diary design comprised of four 14-day bursts of daily surveys with three 14-day intervals that do not include daily surveys. There are three intervention conditions: (A) no intervention; (B) attention-control text messaging; or (C) CBT text messaging intervention. Between bursts 1 and 2 (Interval 1), all participants will be assigned to condition A (no intervention) such that all will complete the first two bursts (28 days) before receiving an intervention. Between bursts 2 and 3 (Interval 2) and bursts 3 and 4 (Interval 3), couples will be randomized to one of the following eight patterns of conditions: AA, AB, AC, BA, BB, BC, CA, or CB. There is no "CC" condition because the CBT intervention is not intended to be given in multiple two-week intervals.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No Intervention, No Intervention (AA)

Participants do not receive text messages during Interval 2 or Interval 3.

Group Type NO_INTERVENTION

No interventions assigned to this group

No Intervention, Attention-Control Texts (AB)

Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.

Group Type ACTIVE_COMPARATOR

Attention Control Text Messaging

Intervention Type BEHAVIORAL

Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions.

No Intervention, CBT Texts (AC)

Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.

Group Type EXPERIMENTAL

CBT Text Messaging

Intervention Type BEHAVIORAL

Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction).

Attention-Control Texts, No Intervention (BA)

Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.

Group Type ACTIVE_COMPARATOR

Attention Control Text Messaging

Intervention Type BEHAVIORAL

Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions.

Attention-Control Texts, Attention-Control Texts (BB)

Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.

Group Type ACTIVE_COMPARATOR

Attention Control Text Messaging

Intervention Type BEHAVIORAL

Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions.

Attention-Control Texts, CBT Texts (BC)

Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.

Group Type EXPERIMENTAL

CBT Text Messaging

Intervention Type BEHAVIORAL

Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction).

Attention Control Text Messaging

Intervention Type BEHAVIORAL

Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions.

CBT Texts, No Intervention (CA)

Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.

Group Type EXPERIMENTAL

CBT Text Messaging

Intervention Type BEHAVIORAL

Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction).

CBT Texts, Attention-Control Texts (CB)

Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.

Group Type EXPERIMENTAL

CBT Text Messaging

Intervention Type BEHAVIORAL

Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction).

Attention Control Text Messaging

Intervention Type BEHAVIORAL

Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CBT Text Messaging

Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction).

Intervention Type BEHAVIORAL

Attention Control Text Messaging

Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Both partners must identify as cisgender and sexual minority or at least one partner must identify as a gender minority (i.e., one's gender identity is non-congruent with their sex assigned at birth)
* 21 years or older
* In an intimate relationship lasting at least one month in which there are at least 2 days of face-to-face contact each week
* Consumption of 4 (assigned female at birth) or 5 (assigned male at birth) alcoholic drinks on at least three days in the past year

Exclusion Criteria

* Seeking treatment or being in recovery for an alcohol or substance use disorder.
* Endorsement of severe physical IPV (e.g., use of a weapon) in the past year.
* Women who self-report that they are trying to get pregnant, that they are currently pregnant, or that they are currently breastfeeding .
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University at Buffalo

OTHER

Sponsor Role collaborator

University of Louisville

OTHER

Sponsor Role collaborator

Georgia State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dominic Parrott

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dominic J Parrott, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Georgia State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Georgia State University

Atlanta, Georgia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01AA025995

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ePREP for Community Couples
NCT01795963 COMPLETED NA
Evaluation of HRP Among Pre-K Through 5th Grade
NCT06388850 ENROLLING_BY_INVITATION NA