Domestic ViolenceNCT03672942
Communication Skills vs. Mindfulness for IPV
A study testing Communication Skills Training and Mindfulness in people with Domestic Violence and Domestic Abuse, run by University of Houston.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence, Domestic Abuse, Family Conflict
- What is being tested?
- Communication Skills Training and Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2019to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult co-habituating couples Reporting some violence in the past year (score > 0 on CTS2 physical abuse subscale)
Who cannot join
- Homosexual couples Children under 18 non-English speakers
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Conditions
- Domestic Violence, Domestic Abuse, Family Conflict, Aggression
- Being tested
- Communication Skills Training, Mindfulness, Placebo
- Keywords
- intimate partner violence, aggression, batterers intervention, mindfulness, communication skills, couples
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication Skills TrainingBehavioural
Also called Gentle Start-up
Gentle start-up is one treatment technique in the Creating Healthy Relationship Program written by John Gottman, Ph.D.
MindfulnessBehavioural
Also called Acceptance/Willingness of unwanted emotions
Acceptance/willingness of unwanted emotions is treatment technique of Achieving Change through Value-Based Behavior (ACTV) written by Amie Zarling, Ph.D.
PlaceboBehavioural
Also called Time Out Condition
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness |
| Placebo | Placebo comparator | Male and female participants will listen to music in lieu for 8 minutes. Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 minutes: Change in aggression from first to second conflict discussion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start15 Sep 2019 (estimated)
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- random assignment to two active conditions vs. a placebo control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia C. Babcock, University of Houston
- Investigators
- Julia C Babcock, Ph.D., Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672942
- Sponsor's protocol ID
- STUDY00000975
- Status last verified
- Apr 2019
- First submitted
- 7 Aug 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared in a data bank.
Publications
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.
PubMed 21496517
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proximal Change Experiment: Testing the Effects of Communication Skills Training vs. Mindfulness Techniques on Intimate Partner Aggression
- ClinicalTrials.gov ID
- NCT03672942
- Acronym / sponsor ID
- STUDY00000975
- Conditions
- Domestic Violence, Domestic Abuse, Family Conflict, Aggression
- Keywords
- intimate partner violence, aggression, batterers intervention, mindfulness, communication skills, couples
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 15 Sep 2019 (estimated)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- random assignment to two active conditions vs. a placebo control
| Arm | Type | Receives |
|---|---|---|
| Communication Skills | Experimental | Behavioral: Communication Skills TrainingMale 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. |
| Mindfulness | Experimental | Behavioral: MindfulnessMale 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. |
| Placebo | Placebo comparator | Behavioral: PlaceboMale and female participants will listen to music in lieu for 8 minutes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult co-habituating couples Reporting some violence in the past year (score > 0 on CTS2 physical abuse subscale)
Key exclusion criteria (1 listed)
- Homosexual couples Children under 18 non-English speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication Skills TrainingAlso: Gentle Start-upGentle start-up is one treatment technique in the Creating Healthy Relationship Program written by John Gottman, Ph.D. | Behavioural | Communication Skills |
| MindfulnessAlso: Acceptance/Willingness of unwanted emotionsAcceptance/willingness of unwanted emotions is treatment technique of Achieving Change through Value-Based Behavior (ACTV) written by Amie Zarling, Ph.D. | Behavioural | Mindfulness |
| PlaceboAlso: Time Out ConditionCouples 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. | Behavioural | Placebo |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Background: PubMed 21496517Babcock 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.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared in a data bank.
Related trials for Domestic Violence
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Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
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Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.
Domestic and/or Sexual Violence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia C Babcock, Ph.D. principal investigator
University of Houston
Questions about this trial
What is this clinical trial studying?
A study testing Communication Skills Training and Mindfulness in people with Domestic Violence and Domestic Abuse, run by University of Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alicia Vargas (713-743-9215, avargas5@central.uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed aggression (time frame: 10 minutes: Change in observed behavior/emotion from first to second conflict discussion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03672942, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.