Clinical trial NCT06526247: Evaluating Interventions for Intimate Partner Violence Use in Washington State
Official title: Evaluating Interventions for Intimate Partner Violence Use in Washington State
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intimate Partner Violence
Keywords: Strength at Home (SAH)
Trauma-informed
Treatment as Usual (TAU)
Posttraumatic stress disorder (PTSD)
Alcohol use
Washington state
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Office of Crime Victims Advocacy - Washington State Department of Commerce
First posted: 2024-07-29
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single site, controlled trial. All participants will be randomized at the individual level to SAH or TAU, with a 1:1 allocation ratio.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

Men:

1. Identify as a man
2. Provide consent for the research team to contact his intimate partner(s) for data collection purposes;
3. Court-referred for IPV intervention in Washington state

Women:

1. Identify as a woman
2. Were or currently are an intimate partner involved in an incident of IPV with a court-referred participant

Exclusion Criteria:

1. demonstrates active psychosis that may interfere with their ability to participate in group
2. expresses prominent suicidal or homicidal ideation that requires hospitalization
3. does not possess proficiency in spoken English
4. periods of incarceration after study enrollment

Primary outcomes:
measure: IPV assessment
timeFrame: Baseline, 3 months, 6 months. 9 months, 12 months
measure: Psychological IPV assessment
timeFrame: Baseline, 3 months, 6 months. 9 months, 12 months
measure: Post Traumatic Stress Disorder (PTSD) symptoms
timeFrame: Baseline, 3 months, 6 months. 9 months, 12 months
measure: Alcohol use
timeFrame: Baseline, 3 months, 6 months. 9 months, 12 months
measure: Alexithymia assessment
timeFrame: Baseline, 3 months, 6 months. 9 months, 12 months
Secondary outcomes:
measure: Treatment Satisfaction
timeFrame: 3 months, 6 months. 9 months, 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: BU Chobanian & Avedisian School of Medicine, Psychiatry
state: Massachusetts
Study officials:
affiliation: BU School of Medicine and National Center for PTSD
name: Casey Taft, PhD
role: PRINCIPAL_INVESTIGATOR
References: