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

Primary Purpose

Alcohol Consumption, Violence, Domestic, Stress, Psychological

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT Text Messaging
Attention Control Text Messaging
Sponsored by
Georgia State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Consumption focused on measuring sexual minority, gender minority

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 .

Sites / Locations

  • Georgia State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

No Intervention

Active Comparator

Experimental

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Arm Label

No Intervention, No Intervention (AA)

No Intervention, Attention-Control Texts (AB)

No Intervention, CBT Texts (AC)

Attention-Control Texts, No Intervention (BA)

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

Attention-Control Texts, CBT Texts (BC)

CBT Texts, No Intervention (CA)

CBT Texts, Attention-Control Texts (CB)

Arm Description

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Sexual or Gender Minority Stress (Burst 1)
Participants will be asked if they experienced discrimination related to their sexual or gender identity.
Sexual or Gender Minority Stress (Burst 2)
Participants will be asked if they experienced discrimination related to their sexual or gender identity.
Sexual or Gender Minority Stress (Burst 3)
Participants will be asked if they experienced discrimination related to their sexual or gender identity.
Sexual or Gender Minority Stress (Burst 4)
Participants will be asked if they experienced discrimination related to their sexual or gender identity.
COVID-19 Stress (Burst 1)
Participants will be asked if they experienced stress related to the COVID-19 pandemic.
COVID-19 Stress (Burst 2)
Participants will be asked if they experienced stress related to the COVID-19 pandemic.
COVID-19 Stress (Burst 3)
Participants will be asked if they experienced stress related to the COVID-19 pandemic.
COVID-19 Stress (Burst 4)
Participants will be asked if they experienced stress related to the COVID-19 pandemic.

Full Information

First Posted
November 6, 2020
Last Updated
April 19, 2023
Sponsor
Georgia State University
Collaborators
University at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT04625465
Brief Title
Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence
Acronym
PASSION
Official Title
Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University
Collaborators
University at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption, Violence, Domestic, Stress, Psychological, Aggression
Keywords
sexual minority, gender minority

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Intervention, No Intervention (AA)
Arm Type
No Intervention
Arm Description
Participants do not receive text messages during Interval 2 or Interval 3.
Arm Title
No Intervention, Attention-Control Texts (AB)
Arm Type
Active Comparator
Arm Description
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
Arm Title
No Intervention, CBT Texts (AC)
Arm Type
Experimental
Arm Description
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
Arm Title
Attention-Control Texts, No Intervention (BA)
Arm Type
Active Comparator
Arm Description
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
Arm Title
Attention-Control Texts, Attention-Control Texts (BB)
Arm Type
Active Comparator
Arm Description
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
Arm Title
Attention-Control Texts, CBT Texts (BC)
Arm Type
Experimental
Arm Description
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
Arm Title
CBT Texts, No Intervention (CA)
Arm Type
Experimental
Arm Description
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
Arm Title
CBT Texts, Attention-Control Texts (CB)
Arm Type
Experimental
Arm Description
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
Intervention Type
Behavioral
Intervention Name(s)
CBT Text Messaging
Intervention Description
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
Intervention Name(s)
Attention Control Text Messaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intimate Partner Violence Events (Burst 1)
Description
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.
Time Frame
Burst 1, Daily for 14 days
Title
Intimate Partner Violence Events (Burst 2)
Description
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.
Time Frame
Burst 2, Daily for 14 days
Title
Intimate Partner Violence Events (Burst 3)
Description
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.
Time Frame
Burst 3, Daily for 14 days
Title
Intimate Partner Violence Events (Burst 4)
Description
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.
Time Frame
Burst 4, Daily for 14 days
Title
Drinking Episodes (Burst 1)
Description
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.
Time Frame
Burst 1, Daily for 14 days
Title
Drinking Episodes (Burst 2)
Description
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.
Time Frame
Burst 2, Daily for 14 days
Title
Drinking Episodes (Burst 3)
Description
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.
Time Frame
Burst 3, Daily for 14 days
Title
Drinking Episodes (Burst 4)
Description
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.
Time Frame
Burst 4, Daily for 14 days
Secondary Outcome Measure Information:
Title
Sexual or Gender Minority Stress (Burst 1)
Description
Participants will be asked if they experienced discrimination related to their sexual or gender identity.
Time Frame
Burst 1, Daily for 14 days
Title
Sexual or Gender Minority Stress (Burst 2)
Description
Participants will be asked if they experienced discrimination related to their sexual or gender identity.
Time Frame
Burst 2, Daily for 14 days
Title
Sexual or Gender Minority Stress (Burst 3)
Description
Participants will be asked if they experienced discrimination related to their sexual or gender identity.
Time Frame
Burst 3, Daily for 14 days
Title
Sexual or Gender Minority Stress (Burst 4)
Description
Participants will be asked if they experienced discrimination related to their sexual or gender identity.
Time Frame
Burst 4, Daily for 14 days
Title
COVID-19 Stress (Burst 1)
Description
Participants will be asked if they experienced stress related to the COVID-19 pandemic.
Time Frame
Burst 1, Daily for 14 days
Title
COVID-19 Stress (Burst 2)
Description
Participants will be asked if they experienced stress related to the COVID-19 pandemic.
Time Frame
Burst 2, Daily for 14 days
Title
COVID-19 Stress (Burst 3)
Description
Participants will be asked if they experienced stress related to the COVID-19 pandemic.
Time Frame
Burst 3, Daily for 14 days
Title
COVID-19 Stress (Burst 4)
Description
Participants will be asked if they experienced stress related to the COVID-19 pandemic.
Time Frame
Burst 4, Daily for 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominic J Parrott, Ph.D.
Phone
404-413-6287
Email
parrott@gsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Konrad Bresin, Ph.D.
Email
kbresin@gsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominic J Parrott, Ph.D.
Organizational Affiliation
Georgia State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia State University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30302
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominic J Parrott, Ph.D.
Phone
404-413-6287
Email
parrott@gsu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence

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