Evaluation of a Trauma-Informed Partner Violence Intervention Program

Boston University

Status: Invitation-only

Conditions: Domestic Violence; Post Traumatic Stress Disorder

Treatments: Behavioral: SAH; Behavioral: TAU

Study type: Interventional

Funder types: Other

Identifiers

NCT06803043

BPS-2023C1-31039 (Other Grant/Funding Number)

H-45014

Details and patient eligibility

About

The goal of this study is to conduct a randomized controlled trial (RCT) comparing outcomes between two programs to reduce intimate partner violence (IPV)- the Strength at Home (SAH) program and a standard, state-approved IPV intervention program, Treatment as Usual (TAU). Primary outcomes will include self- and partner-reported physical and psychological IPV. Secondary outcomes will include self-reported PTSD symptoms, alexithymia, alcohol use problems, and treatment satisfaction, assessed across five time points.

Full description

A mixed-methods approach will be used for this single site, parallel group RCT. All participants will be randomized at the individual level to Strength at Home (SAH) or Treatment as Usual (TAU), with a 1:1 allocation ratio. Assessments will occur pre-treatment and post-treatment with follow-up assessments scheduled every three months post-treatment through month 12. Assessments have been designed to examine reductions in IPV and other outcomes including posttraumatic stress disorder (PTSD) symptoms and alcohol use.

The primary hypotheses are that those receiving SAH will evidence greater reductions in physical and psychological IPV, symptoms of PTSD, alexithymia, and alcohol use problems, and higher treatment satisfaction relative to those receiving TAU across the time points.

The specific aims and sub aims are:

1. Test the comparative effectiveness of SAH and TAU by conducting an RCT comparing 200 justice-involved men randomly assigned to each program.

   • 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). Additionally, at Time 5, the study may make use of available arrest record data from the state of Rhode Island.
   • Compare symptoms of PTSD, alexithymia, and alcohol use problems across conditions and assessment time points as reported by the male participants.
   • Compare treatment satisfaction across conditions as reported by the male participants across the four 3-month follow ups (Times 2-5).

2. Facilitate future use of SAH by working closely with the Stakeholder Advisory Board to identify potential barriers and facilitators to successful implementation in civilian community settings.

   • Identify barriers and facilitators to implementation.
   • Assess the acceptability of SAH among stakeholders in the community setting and areas in need of refinement.

Enrollment: 800 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men court-mandated to IPV intervention from the Rhode Island Department of Parole and Probation and their partners

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Strength at Home (SAH)

Experimental group

Description:

SAH isa trauma-informed 12-week intimate partner violence (IPV) intervention program.

Treatment:

Behavioral: SAH

Treatment as Usual (TAU)

Active Comparator group

Description:

TAU is a 20-week state-approved IPV intervention program.

Treatment:

Behavioral: TAU