NCT06526247

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress56%
Nov 2024Jul 2027

First Submitted

Initial submission to the registry

July 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

November 18, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

2.6 years

First QC Date

July 25, 2024

Last Update Submit

July 28, 2025

Conditions

Keywords

Strength at Home (SAH)Trauma-informedTreatment as Usual (TAU)Posttraumatic stress disorder (PTSD)Alcohol useWashington state

Outcome Measures

Primary Outcomes (5)

  • IPV assessment

    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

  • Psychological IPV assessment

    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

  • Post Traumatic Stress Disorder (PTSD) symptoms

    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

    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

    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

Secondary Outcomes (1)

  • Treatment Satisfaction

    3 months, 6 months. 9 months, 12 months

Study Arms (2)

Strength at Home (SAH)

EXPERIMENTAL

Participants randomized into this arm with receive a trauma-informed intimate partner violence (IPV) intervention program.

Behavioral: Strength at Home (SAH)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Participants randomized into this arm with receive a standard IPV intervention program in the state of Washington.

Behavioral: Treatment as usual for IPV

Interventions

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.

Strength at Home (SAH)

Treatment as usual for IPV includes court-mandated interventions delivered over the 26 two-hour weekly sessions in Washington state.

Treatment as Usual (TAU)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BU Chobanian & Avedisian School of Medicine, Psychiatry

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAlcohol Drinking

Interventions

TherapeuticsPoliovirus Vaccine, Inactivated

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

Vaccines, InactivatedVaccinesBiological ProductsComplex MixturesPoliovirus VaccinesViral Vaccines

Study Officials

  • Casey Taft, PhD

    BU School of Medicine and National Center for PTSD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Casey Taft, PhD

CONTACT

Megan Kopitsky, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single site, controlled trial. All participants will be randomized at the individual level to SAH or TAU, with a 1:1 allocation ratio.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2024

First Posted

July 29, 2024

Study Start

November 18, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations