NCT03672942

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
12 months until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

August 7, 2018

Last Update Submit

April 16, 2019

Conditions

Keywords

intimate partner violenceaggressionbatterers interventionmindfulnesscommunication skillscouples

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

Communication Skills

EXPERIMENTAL

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

Mindfulness

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Male and female participants will listen to music in lieu for 8 minutes.

Behavioral: Placebo

Interventions

Gentle start-up is one treatment technique in the Creating Healthy Relationship Program written by John Gottman, Ph.D.

Also known as: Gentle Start-up
Communication Skills
MindfulnessBEHAVIORAL

Acceptance/willingness of unwanted emotions is treatment technique of Achieving Change through Value-Based Behavior (ACTV) written by Amie Zarling, Ph.D.

Also known as: Acceptance/Willingness of unwanted emotions
Mindfulness
PlaceboBEHAVIORAL

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.

Also known as: Time Out Condition
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult co-habituating couples Reporting some violence in the past year (score \> 0 on CTS2 physical abuse subscale)

You may not qualify if:

  • Homosexual couples Children under 18 non-English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 21496517BACKGROUND

MeSH Terms

Conditions

Aggression

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Julia C Babcock, Ph.D.

    University of Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
couples are not informed as to what condition they are assigned
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: random assignment to two active conditions vs. a placebo control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 7, 2018

First Posted

September 17, 2018

Study Start

September 15, 2019

Primary Completion

September 15, 2021

Study Completion

September 15, 2022

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

Deidentified data will be shared in a data bank.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data requests will be reviewed by a Data Panel Review Board