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

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ClinicalTrials.gov Identifier: NCT04625465
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : January 7, 2021
Sponsor:
Collaborator:
University at Buffalo
Information provided by (Responsible Party):
Dominic Parrott, Georgia State University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alcohol Consumption Violence, Domestic Stress, Psychological Aggression Behavioral: CBT Text Messaging Behavioral: Attention Control Text Messaging Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence
Actual Study Start Date : November 12, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022
Arms and Interventions
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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: 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).

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: 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: 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).

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.


Outcome Measures
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Primary Outcome Measures :
  1. Intimate Partner Violence Events (Burst 1) [ Time Frame: Burst 1, Daily for 14 days ]
    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.

  2. Intimate Partner Violence Events (Burst 2) [ Time Frame: Burst 2, Daily for 14 days ]
    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.

  3. Intimate Partner Violence Events (Burst 3) [ Time Frame: Burst 3, Daily for 14 days ]
    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.

  4. Intimate Partner Violence Events (Burst 4) [ Time Frame: Burst 4, Daily for 14 days ]
    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.

  5. Drinking Episodes (Burst 1) [ Time Frame: Burst 1, Daily for 14 days ]
    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.

  6. Drinking Episodes (Burst 2) [ Time Frame: Burst 2, Daily for 14 days ]
    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.

  7. Drinking Episodes (Burst 3) [ Time Frame: Burst 3, Daily for 14 days ]
    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.

  8. Drinking Episodes (Burst 4) [ Time Frame: Burst 4, Daily for 14 days ]
    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 :
  1. Sexual or Gender Minority Stress (Burst 1) [ Time Frame: Burst 1, Daily for 14 days ]
    Participants will be asked if they experienced discrimination related to their sexual or gender identity.

  2. Sexual or Gender Minority Stress (Burst 2) [ Time Frame: Burst 2, Daily for 14 days ]
    Participants will be asked if they experienced discrimination related to their sexual or gender identity.

  3. Sexual or Gender Minority Stress (Burst 3) [ Time Frame: Burst 3, Daily for 14 days ]
    Participants will be asked if they experienced discrimination related to their sexual or gender identity.

  4. Sexual or Gender Minority Stress (Burst 4) [ Time Frame: Burst 4, Daily for 14 days ]
    Participants will be asked if they experienced discrimination related to their sexual or gender identity.

  5. COVID-19 Stress (Burst 1) [ Time Frame: Burst 1, Daily for 14 days ]
    Participants will be asked if they experienced stress related to the COVID-19 pandemic.

  6. COVID-19 Stress (Burst 2) [ Time Frame: Burst 2, Daily for 14 days ]
    Participants will be asked if they experienced stress related to the COVID-19 pandemic.

  7. COVID-19 Stress (Burst 3) [ Time Frame: Burst 3, Daily for 14 days ]
    Participants will be asked if they experienced stress related to the COVID-19 pandemic.

  8. COVID-19 Stress (Burst 4) [ Time Frame: Burst 4, Daily for 14 days ]
    Participants will be asked if they experienced stress related to the COVID-19 pandemic.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 .
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625465


Contacts
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Contact: Dominic J Parrott, Ph.D. 404-413-6287 parrott@gsu.edu
Contact: Konrad Bresin, Ph.D. kbresin@gsu.edu

Locations
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United States, Georgia
Georgia State University Recruiting
Atlanta, Georgia, United States, 30302
Contact: Dominic J Parrott, Ph.D.    404-413-6287    parrott@gsu.edu   
Sponsors and Collaborators
Georgia State University
University at Buffalo
Investigators
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Principal Investigator: Dominic J Parrott, Ph.D. Georgia State University
  Study Documents (Full-Text)

Documents provided by Dominic Parrott, Georgia State University:
Informed Consent Form  [PDF] October 13, 2020

More Information
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Responsible Party: Dominic Parrott, Principal Investigator, Georgia State University
ClinicalTrials.gov Identifier: NCT04625465    
Other Study ID Numbers: R01AA025995 ( U.S. NIH Grant/Contract )
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: One year after the study is completed, all data will be compiled and organized into a single repository at ICPSR.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dominic Parrott, Georgia State University:
sexual minority
gender minority
Additional relevant MeSH terms:
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Aggression
Alcohol Drinking
Stress, Psychological
Behavioral Symptoms
Drinking Behavior