Clinical trial NCT04625465: Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence
Official title: Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Violence, Domestic
Stress, Psychological
Aggression
Keywords: sexual minority
gender minority
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: University at Buffalo
name: University of Louisville
First posted: 2020-11-12
Enrollment: 480
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria (applies to both partners):

* 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 .

Primary outcomes:
measure: Intimate Partner Violence Events (Burst 1)
timeFrame: Burst 1, Daily for 14 days
measure: Intimate Partner Violence Events (Burst 2)
timeFrame: Burst 2, Daily for 14 days
measure: Intimate Partner Violence Events (Burst 3)
timeFrame: Burst 3, Daily for 14 days
measure: Intimate Partner Violence Events (Burst 4)
timeFrame: Burst 4, Daily for 14 days
measure: Drinking Episodes (Burst 1)
timeFrame: Burst 1, Daily for 14 days
measure: Drinking Episodes (Burst 2)
timeFrame: Burst 2, Daily for 14 days
measure: Drinking Episodes (Burst 3)
timeFrame: Burst 3, Daily for 14 days
measure: Drinking Episodes (Burst 4)
timeFrame: Burst 4, Daily for 14 days
Secondary outcomes:
measure: Sexual or Gender Minority Stress (Burst 1)
timeFrame: Burst 1, Daily for 14 days
measure: Sexual or Gender Minority Stress (Burst 2)
timeFrame: Burst 2, Daily for 14 days
measure: Sexual or Gender Minority Stress (Burst 3)
timeFrame: Burst 3, Daily for 14 days
measure: Sexual or Gender Minority Stress (Burst 4)
timeFrame: Burst 4, Daily for 14 days
measure: COVID-19 Stress (Burst 1)
timeFrame: Burst 1, Daily for 14 days
measure: COVID-19 Stress (Burst 2)
timeFrame: Burst 2, Daily for 14 days
measure: COVID-19 Stress (Burst 3)
timeFrame: Burst 3, Daily for 14 days
measure: COVID-19 Stress (Burst 4)
timeFrame: Burst 4, Daily for 14 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Georgia State University
name: Dominic J Parrott, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: