Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence (PASSION)

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.

Study Overview

• Status: Completed
• Conditions: Aggression; Stress, Psychological; Violence, Domestic; Alcohol Consumption
• Intervention / Treatment: Behavioral: Attention Control Text Messaging; Behavioral: CBT Text Messaging

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominic J Parrott, Ph.D.; Phone Number: 404-413-6287; Email: parrott@gsu.edu
• Study Contact Backup: Name: Konrad Bresin, Ph.D.; Email: kbresin@gsu.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30302
      • Georgia State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Intervention, No Intervention (AA); Participants do not receive text messages during Interval 2 or Interval 3.
Active Comparator: No Intervention, Attention-Control Texts (AB); Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.	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.
Experimental: No Intervention, CBT Texts (AC); Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.	Behavioral: 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).
Active Comparator: Attention-Control Texts, No Intervention (BA); Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.	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.
Active Comparator: 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.	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.
Experimental: Attention-Control Texts, CBT Texts (BC); Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.	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.; Behavioral: 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).
Experimental: CBT Texts, No Intervention (CA); Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.	Behavioral: 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).
Experimental: CBT Texts, Attention-Control Texts (CB); Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.	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.; Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intimate Partner Violence Events (Burst 1)	Participants will be asked if they experienced relationship conflict since the last report. If so, they will be asked questions about physical and/or verbal perpetration and victimization and time of occurrence.	Burst 1, Daily for 14 days
Intimate Partner Violence Events (Burst 2)	Participants will be asked if they experienced relationship conflict since the last report. If so, they will be asked questions about physical and/or verbal perpetration and victimization and time of occurrence.	Burst 2, Daily for 14 days
Intimate Partner Violence Events (Burst 3)	Participants will be asked if they experienced relationship conflict since the last report. If so, they will be asked questions about physical and/or verbal perpetration and victimization and time of occurrence.	Burst 3, Daily for 14 days
Intimate Partner Violence Events (Burst 4)	Participants will be asked if they experienced relationship conflict since the last report. If so, they will be asked questions about physical and/or verbal perpetration and victimization and time of occurrence.	Burst 4, Daily for 14 days
Drinking Episodes (Burst 1)	Participants will be asked if they consumed alcohol since the last daily report. If so, they will be asked questions about the time they drank, amount of alcohol consumed, subjective intoxication, location, with whom they drank, and illicit substance use.	Burst 1, Daily for 14 days
Drinking Episodes (Burst 2)	Participants will be asked if they consumed alcohol since the last daily report. If so, they will be asked questions about the time they drank, amount of alcohol consumed, subjective intoxication, location, with whom they drank, and illicit substance use.	Burst 2, Daily for 14 days
Drinking Episodes (Burst 3)	Participants will be asked if they consumed alcohol since the last daily report. If so, they will be asked questions about the time they drank, amount of alcohol consumed, subjective intoxication, location, with whom they drank, and illicit substance use.	Burst 3, Daily for 14 days
Drinking Episodes (Burst 4)	Participants will be asked if they consumed alcohol since the last daily report. If so, they will be asked questions about the time they drank, amount of alcohol consumed, subjective intoxication, location, with whom they drank, and illicit substance use.	Burst 4, Daily for 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual or Gender Minority Stress (Burst 1)	Participants will be asked if they experienced discrimination related to their sexual or gender identity.	Burst 1, Daily for 14 days
Sexual or Gender Minority Stress (Burst 2)	Participants will be asked if they experienced discrimination related to their sexual or gender identity.	Burst 2, Daily for 14 days
Sexual or Gender Minority Stress (Burst 3)	Participants will be asked if they experienced discrimination related to their sexual or gender identity.	Burst 3, Daily for 14 days
Sexual or Gender Minority Stress (Burst 4)	Participants will be asked if they experienced discrimination related to their sexual or gender identity.	Burst 4, Daily for 14 days
COVID-19 Stress (Burst 1)	Participants will be asked if they experienced stress related to the COVID-19 pandemic.	Burst 1, Daily for 14 days
COVID-19 Stress (Burst 2)	Participants will be asked if they experienced stress related to the COVID-19 pandemic.	Burst 2, Daily for 14 days
COVID-19 Stress (Burst 3)	Participants will be asked if they experienced stress related to the COVID-19 pandemic.	Burst 3, Daily for 14 days
COVID-19 Stress (Burst 4)	Participants will be asked if they experienced stress related to the COVID-19 pandemic.	Burst 4, Daily for 14 days

Collaborators and Investigators

• Sponsor: Georgia State University
• Collaborators: University at Buffalo; University of Louisville
• Investigators: Principal Investigator: Dominic J Parrott, Ph.D., Georgia State University

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2020
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: gender minority; sexual minority
• Additional Relevant MeSH Terms: Behavioral Symptoms; Drinking Behavior; Aggression; Alcohol Drinking; Stress, Psychological
• Other Study ID Numbers: R01AA025995 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the grant period, access to the data will be provided through the Inter-University Consortium for Political and Social Research (ICPSR). Users will be required to agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data source and funders. One year after the study is completed, all data will be compiled and organized into a single repository at ICPSR. Data will be made publicly available through ICPSR's website.
• IPD Sharing Time Frame: One year after the study is completed, all data will be compiled and organized into a single repository at ICPSR.
• IPD Sharing Access Criteria: Users will be required to agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data source and funders.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No