- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03672942
Communication Skills vs. Mindfulness for IPV
April 16, 2019 updated by: Julia C. Babcock, University of Houston
A Proximal Change Experiment: Testing the Effects of Communication Skills Training vs. Mindfulness Techniques on Intimate Partner Aggression
This tests the immediate impact of two brief interventions on couples reporting intimate partner violence using the proximal change experimental design.
Couples will be randomly assigned to a mindfulness conditions, a communication exercise or a placebo condition.
Outcome measures include observed and experimentally assessed aggression.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This pilot study is designed to test the effects of two brief interventions on communication and emotional expression between intimate partners who have experienced recent domestic violence.
In addition, it will provide some basic laboratory findings on differences in distress tolerance between perpetrators and victims of domestic abuse.
Specifically, using the proximal change experimental design, couples will engaged in a 7.5 minute conflict discussion while being videotaped and having their autonomic responding monitored.
Then they will be randomly assigned to one of three conditions: a communication skills training exercise, a mindfulness condition, or a placebo control.
Next, ,couples will engaged in second 7.5 minute conflict discussion.
It is hypothesized that those in both the communication skills training and mindfulness condition will display more positive and less aggressive behavior in their second conflict discussion as compared to their first.
It is also expected that they will administer less aggression (as measured by delivery of a loud noise) to their partner after both of the active interventions.
In addition, multiple measures of distress tolerance will be administered to both partners.
It is expected that couples with a characterologically violent perpetrator, he or she will evidence decreased distress tolerance and the victimized partner will evidence increased distress tolerance
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alicia Vargas
- Phone Number: 713-743-9215
- Email: avargas5@central.uh.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Adult co-habituating couples Reporting some violence in the past year (score > 0 on CTS2 physical abuse subscale)
Exclusion Criteria:
Homosexual couples Children under 18 non-English speakers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Communication Skills
Male and female participants will listen to a description of John Gottman's Gentle Start-up communication skills training exercise and practice the technique in the lab for approximately 8 minutes.
|
Gentle start-up is one treatment technique in the Creating Healthy Relationship Program written by John Gottman, Ph.D.
Other Names:
|
Experimental: Mindfulness
Male and female participants will listen to a script about Acceptance/Willingness of unwanted emotions written by Amie Zarling and practice this technique in the lab for approximately 8 minutes.
|
Acceptance/willingness of unwanted emotions is treatment technique of Achieving Change through Value-Based Behavior (ACTV) written by Amie Zarling, Ph.D.
Other Names:
|
Placebo Comparator: Placebo
Male and female participants will listen to music in lieu for 8 minutes.
|
Couples randomly assigned to this condition listen to music on headphones.
This may be considered an active placebo as it is similar to a Time Out technique taught in battering interventions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Observed aggression
Time Frame: 10 minutes: Change in observed behavior/emotion from first to second conflict discussion
|
Specific Affect Coding System (SPAFF; Gottman, McCoy, Coan, Collier, 1996).
SPAFF categorizes 16 emotions based on facial affect, vocal tone, body language, and content of speech.
|
10 minutes: Change in observed behavior/emotion from first to second conflict discussion
|
TAPS aggression paradigm
Time Frame: 10 minutes: Change in aggression from first to second conflict discussion
|
Overt aggression will be assessed using a modified version of the Taylor Aggression Paradigm (TAP; Epstein & Taylor, 1967).
The TAP is an established method to study aggression in the laboratory.
It is a deceptive, competitive reaction time task in which the participant competes against an "opponent" which is actually the computer program.
|
10 minutes: Change in aggression from first to second conflict discussion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julia C Babcock, Ph.D., University of Houston
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 15, 2019
Primary Completion (Anticipated)
September 15, 2021
Study Completion (Anticipated)
September 15, 2022
Study Registration Dates
First Submitted
August 7, 2018
First Submitted That Met QC Criteria
September 12, 2018
First Posted (Actual)
September 17, 2018
Study Record Updates
Last Update Posted (Actual)
April 18, 2019
Last Update Submitted That Met QC Criteria
April 16, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000975
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified data will be shared in a data bank.
IPD Sharing Time Frame
Data requests will be reviewed by a Data Panel Review Board
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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