- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06526247
Evaluating Interventions for Intimate Partner Violence Use in Washington State
Intimate partner violence (IPV), specifically physical and psychological aggression toward an intimate partner, represents a public health crisis that affects millions of Americans each year. There currently exists very little evidence from randomized controlled trials for the effectiveness of abuser intervention programs designed to prevent and end perpetration of IPV in the general population. This is troubling considering that approximately half a million men and women are court-mandated to these programs each year.
The investigators will conduct a randomized control trial (RCT) investigating the efficacy of the Strength at Home (SAH) intervention in reducing intimate partner violence (IPV). The overarching aim of this study is to test the efficacy of SAH with court-involved-partner-violent men through an RCT comparing those who receive SAH with those who receive other standard IPV interventions offered in the state of Washington (treatment as usual- TAU).
The specific aims are:
1.1: Compare the frequency of physical and psychological IPV, the primary outcomes of interest, across conditions as reported by the male participants and their intimate partners across Time 1 (baseline) and four 3-month follow ups (Times 2-5). It is expected that greater reductions in IPV frequencies will be evidenced in SAH than TAU over the course of the year.
1.2: Compare symptoms of PTSD, alexithymia, and alcohol use problems across conditions and assessment time points as reported by the male participants. It is expected that greater reductions in these symptoms will be evidenced in SAH than TAU over the course of the year.
1.3: Compare treatment satisfaction across conditions as reported by the male participants across the four 3-month follow ups (Times 2-5). It is expected that treatment satisfaction will be higher in SAH than TAU.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Casey Taft, PhD
- Phone Number: 857-214-0986
- Email: taft@bu.edu
Study Contact Backup
- Name: Megan Kopitsky, BS
- Email: megan.kopitsky@va.gov
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02118
- Recruiting
- BU Chobanian & Avedisian School of Medicine, Psychiatry
-
Contact:
- Casey Taft, PhD
- Phone Number: 857-214-0986
- Email: taft@bu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Men:
- Identify as a man
- Provide consent for the research team to contact his intimate partner(s) for data collection purposes;
- Court-referred for IPV intervention in Washington state
Women:
- Identify as a woman
- Were or currently are an intimate partner involved in an incident of IPV with a court-referred participant
Exclusion Criteria:
- demonstrates active psychosis that may interfere with their ability to participate in group
- expresses prominent suicidal or homicidal ideation that requires hospitalization
- does not possess proficiency in spoken English
- periods of incarceration after study enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Strength at Home (SAH)
Participants randomized into this arm with receive a trauma-informed intimate partner violence (IPV) intervention program.
|
SAH is a group intervention that incorporates elements from interventions for violence and trauma.
It is administered during 12 two-hour weekly sessions.
The program uses a social information processing model based on the premise that trauma negatively impacts one's ability to interpret and respond to social situations effectively.
It underscores the importance of cognitive behavioral strategies to monitor one's thoughts and responses to interpersonal situations.
|
|
Active Comparator: Treatment as Usual (TAU)
Participants randomized into this arm with receive a standard IPV intervention program in the state of Washington.
|
Treatment as usual for IPV includes court-mandated interventions delivered over the 26 two-hour weekly sessions in Washington state.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IPV assessment
Time Frame: Baseline, 3 months, 6 months. 9 months, 12 months
|
The revised Conflict Tactics Scales (CTS2), a 20-item instrument, will be used to assess IPV.
The Physical Assault (12 items) and Psychological Aggression (8 items) subscales will be administered.
Each of the 20 items is scored by the frequency of occurrence of the item with 8 choices 1-7 and 0.
|
Baseline, 3 months, 6 months. 9 months, 12 months
|
|
Post Traumatic Stress Disorder (PTSD) symptoms
Time Frame: Baseline, 3 months, 6 months. 9 months, 12 months
|
The 20-item PTSD Checklist for DSM 5 (PCL-5) will be used to assess PTSD symptoms.
It is a self-report measure.
Items are rated on a 5-point Likert scale [0 to 4] and summed.
Scores range from 0 to 80 with higher scores associated with more PTSD symptoms.
A total score of 33 or higher may indicate severe PTSD.
|
Baseline, 3 months, 6 months. 9 months, 12 months
|
|
Alcohol use
Time Frame: Baseline, 3 months, 6 months. 9 months, 12 months
|
The 10-item Alcohol Use Disorders Identification Test (AUDIT) will be used to assess problem drinking behavior over the past six months, with higher scores reflecting greater alcohol misuse.
|
Baseline, 3 months, 6 months. 9 months, 12 months
|
|
Alexithymia assessment
Time Frame: Baseline, 3 months, 6 months. 9 months, 12 months
|
The 20-itemToronto Alexithymia Scale (TAS-20) will be used to assess alexithymia.
The TAS-20 uses cutoff scoring, with scores of 52-60 indicating possible alexithymia, and scores above 60 indicating alexithymia.
|
Baseline, 3 months, 6 months. 9 months, 12 months
|
|
Psychological IPV assessment
Time Frame: Baseline, 3 months, 6 months. 9 months, 12 months
|
The 7-item Restrictive Engulfment subscale of the Multidimensional Measure of Emotional Abuse (MMEA) will be used as an additional measure of psychological IPV.
Each item has 7 potential responses from 0=never to 6= more than 20 times.
Scores can range from 0 to 42, with higher scores being associated with more psychological IPV.
|
Baseline, 3 months, 6 months. 9 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Satisfaction
Time Frame: 3 months, 6 months. 9 months, 12 months
|
Participants' satisfaction will be assessed with a 4-item measure used in a study conducted by the Treatment of Depression Collaborative Research Program.
|
3 months, 6 months. 9 months, 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Casey Taft, PhD, BU School of Medicine and National Center for PTSD
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H-44938
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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