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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03672942
Other study ID # STUDY00000975
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 15, 2019
Est. completion date September 15, 2022

Study information

Verified date April 2019
Source University of Houston
Contact Alicia Vargas
Phone 713-743-9215
Email avargas5@central.uh.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 15, 2022
Est. primary completion date September 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

Behavioral:
Communication Skills Training
Gentle start-up is one treatment technique in the Creating Healthy Relationship Program written by John Gottman, Ph.D.
Mindfulness
Acceptance/willingness of unwanted emotions is treatment technique of Achieving Change through Value-Based Behavior (ACTV) written by Amie Zarling, Ph.D.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Houston

References & Publications (1)

Babcock JC, Graham K, Canady B, Ross JM. A proximal change experiment testing two communication exercises with intimate partner violent men. Behav Ther. 2011 Jun;42(2):336-47. doi: 10.1016/j.beth.2010.08.010. Epub 2011 Feb 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Observed aggression 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
Primary TAPS aggression paradigm 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
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