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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Communication Skills Training
Gentle start-up is one treatment technique in the Creating Healthy Relationship Program written by John Gottman, Ph.D.
Other Names:
  • Gentle Start-up
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.
Behavioral: Mindfulness
Acceptance/willingness of unwanted emotions is treatment technique of Achieving Change through Value-Based Behavior (ACTV) written by Amie Zarling, Ph.D.
Other Names:
  • Acceptance/Willingness of unwanted emotions
Placebo Comparator: Placebo
Male and female participants will listen to music in lieu for 8 minutes.
Behavioral: Placebo
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:
  • Time Out Condition

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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