- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04625465
Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence (PASSION)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30302
- Georgia State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
|
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.
|
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.
|
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.
|
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.
|
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.
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.
|
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.
|
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.
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 |
|---|---|---|
|
Alcohol Use (Burst 1)
Time Frame: Burst 1, Daily for 14 days
|
Proportion of reporting days on which alcohol was consumed
|
Burst 1, Daily for 14 days
|
|
Alcohol Use (Burst 2)
Time Frame: Burst 2, Daily for 14 days
|
Proportion of reporting days on which alcohol was consumed
|
Burst 2, Daily for 14 days
|
|
Alcohol Use (Burst 3)
Time Frame: Burst 3, Daily for 14 days
|
Proportion of reporting days on which alcohol was consumed
|
Burst 3, Daily for 14 days
|
|
Alcohol Use (Burst 4)
Time Frame: Burst 4, Daily for 14 days
|
Proportion of reporting days on which alcohol was consumed
|
Burst 4, Daily for 14 days
|
|
Intimate Partner Violence (IPV) Perpetration (Burst 1)
Time Frame: Burst 1, Daily for 14 days
|
Proportion of reporting days on which IPV perpetration occurred
|
Burst 1, Daily for 14 days
|
|
IPV Perpetration (Burst 2)
Time Frame: Burst 2, Daily for 14 days
|
Proportion of reporting days on which IPV perpetration occurred
|
Burst 2, Daily for 14 days
|
|
IPV Perpetration (Burst 3)
Time Frame: Burst 3, Daily for 14 days
|
Proportion of reporting days on which IPV perpetration occurred
|
Burst 3, Daily for 14 days
|
|
IPV Perpetration (Burst 4)
Time Frame: Burst 4, Daily for 14 days
|
Proportion of reporting days on which IPV perpetration occurred
|
Burst 4, Daily for 14 days
|
|
Alcohol Use --> IPV Perpetration (Pre-Intervention)
Time Frame: Bursts 1 and 2 (daily for 14 x 2 days)
|
Odds ratio (OR) of IPV perpetration corresponding to alcohol use (versus non-use). Estimated using a multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2). |
Bursts 1 and 2 (daily for 14 x 2 days)
|
|
Alcohol Use --> IPV Perpetration (Post-Intervention)
Time Frame: Bursts 3 and 4 (daily for 14 x 2 days)
|
Odds ratio (OR) of IPV perpetration corresponding to alcohol use (versus non-use). Estimated using a multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2). |
Bursts 3 and 4 (daily for 14 x 2 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sexual Minority Stress (Burst 1)
Time Frame: Burst 1, Daily for 14 days
|
Total daily count across 15 daily sexual minority stress (SMS) indicators
|
Burst 1, Daily for 14 days
|
|
Sexual Minority Stress (Burst 2)
Time Frame: Burst 2, Daily for 14 days
|
Total daily count across 15 daily sexual minority stress (SMS) indicators
|
Burst 2, Daily for 14 days
|
|
Sexual Minority Stress (Burst 3)
Time Frame: Burst 3, Daily for 14 days
|
Total daily count across 15 daily sexual minority stress (SMS) indicators
|
Burst 3, Daily for 14 days
|
|
Sexual Minority Stress (Burst 4)
Time Frame: Burst 4, Daily for 14 days
|
Total daily count across 15 daily sexual minority stress (SMS) indicators
|
Burst 4, Daily for 14 days
|
|
Gender Minority Stress (Burst 1)
Time Frame: Burst 1, Daily for 14 days
|
Total daily count across 14 daily gender minority stress (GMS) indicators
|
Burst 1, Daily for 14 days
|
|
Gender Minority Stress (Burst 2)
Time Frame: Burst 2, Daily for 14 days
|
Total daily count across 14 daily gender minority stress (GMS) indicators
|
Burst 2, Daily for 14 days
|
|
Gender Minority Stress (Burst 3)
Time Frame: Burst 3, Daily for 14 days
|
Total daily count across 14 daily gender minority stress (GMS) indicators
|
Burst 3, Daily for 14 days
|
|
Gender Minority Stress (Burst 4)
Time Frame: Burst 4, Daily for 14 days
|
Total daily count across 14 daily gender minority stress (GMS) indicators
|
Burst 4, Daily for 14 days
|
|
COVID Stress (Burst 1)
Time Frame: Burst 1, Daily for 14 days
|
Average daily count of COVID stress (CS) indicators
|
Burst 1, Daily for 14 days
|
|
COVID Stress (Burst 2)
Time Frame: Burst 2, Daily for 14 days
|
Average daily count of COVID stress (CS) indicators
|
Burst 2, Daily for 14 days
|
|
COVID Stress (Burst 3)
Time Frame: Burst 3, Daily for 14 days
|
Average daily count of COVID stress (CS) indicators
|
Burst 3, Daily for 14 days
|
|
COVID Stress (Burst 4)
Time Frame: Burst 4, Daily for 14 days
|
Average daily count of COVID stress (CS) indicators
|
Burst 4, Daily for 14 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dominic J Parrott, Ph.D., Georgia State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AA025995 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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