Clinical trial NCT06803043: Evaluation of a Trauma-Informed Partner Violence Intervention Program
Official title: A Randomized Controlled Trial to Evaluate a Trauma-Informed Partner Violence Intervention Program
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Domestic Violence
Post Traumatic Stress Disorder
Keywords: Strength at Home (SAH)
Group intervention
Motivational strategies
Justice-involved men
Alcohol use
Alexithymia
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Rhode Island Hospital
name: Patient-Centered Outcomes Research Institute
First posted: 2025-01-31
Enrollment: 800
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A mixed-methods approach will be used for this single site, parallel group RCT. Participants will be randomized at the individual level to Strength at Home (SAH) or Treatment as Usual (TAU), with a 1:1 allocation ratio.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

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
Secondary outcomes:
measure: Post traumatic stress disorder (PTSD)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Alexithymia
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Alcohol Use
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Treatment satisfaction
timeFrame: 3 months, 6 months, 9 months, 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: CABU School of Medicine, Psychiatry
state: Massachusetts
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: CABU School Medicine, Psychiatry
name: Casey T Taft, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Lindsay Orchowski, PhD
role: PRINCIPAL_INVESTIGATOR
References: