Domestic ViolenceNCT06803043

Evaluation of a Trauma-Informed Partner Violence Intervention Program

A study testing SAH and TAU in people with Domestic Violence and Post Traumatic Stress Disorder, run by Boston University at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Domestic Violence, Post Traumatic Stress Disorder
What is being tested?: SAH and TAU
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,000 participants
Where: 1 siteUnited States
Study dates: 13 Feb 2025to Dec 2028
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

BU Chobanian & Avedisian School of Medicine, Psychiatry
Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: A Randomized Controlled Trial to Evaluate a Trauma-Informed Partner Violence Intervention Program

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.

Read the 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:

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).

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.

Conditions: Domestic Violence, Post Traumatic Stress Disorder
Being tested: SAH, TAU
Keywords: Strength at Home (SAH), Group intervention, Motivational strategies, Justice-involved men, Alcohol use, Alexithymia
Medical subject headings: Stress Disorders, Post-Traumatic, Alcohol Drinking, Affective Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SAHBehavioural
SAH is a group trauma informed intervention that uses motivational strategies and self-monitoring of one's thoughts and responses. It provides a unique fusion of interventions for trauma and IPV and consists of 12 two-hour weekly sessions. Throughout the program, group members complete in-session practice exercises and are provided "practice assignments" to consolidate and apply information learned in group.
TAUBehavioural
TAU is a court mandated 20 week, psychoeducational/directed program that emphasizes the sharing of power and control in relationships and personal accountability. Topics also focus on equality wheels, substance abuse impacts, culture and socialization impact on gender roles, defense mechanisms versus coping skills, triggers for stress and anger, and healthy versus unhealthy communication.

Study groups in NCT06803043
Study group	Role	What they receive
Strength at Home (SAH)	Experimental	SAH isa trauma-informed 12-week intimate partner violence (IPV) intervention program. Receives: Behavioral: SAH
Treatment as Usual (TAU)	Active comparator	TAU is a 20-week state-approved IPV intervention program. Receives: Behavioral: TAU

What is being measured

The primary outcome is the main question the study is designed to answer.

IPV Assessment
The Revised Conflict Tactics Scale (CTS2) is a 39-item measure of individual engagement in or experience of physical or psychological violence with an intimate partner. Each item is asked about both the respondent and the respondent's partner, for a total of 78 questions.The response options include 8 choices (Categories 1-7 and 0). An answer of Category 1 or 2 is coded as the corresponding number of times the specified incident occurred (once or twice in the past year). For Categories 3-5, the midpoint of the category is coded. For example: Category 3 (3-5 times) is coded as 4, Category 4 (6-10 times) is coded as 8, and Category 5 (11-20 times) is coded as 15. Category 6 (More than 20 times) should be coded as 25. Category 7 is given a score of 0 if scores for the previous year do not reflect abuse or conflict. Total scores can range from 0 to 975 and lower scores suggest less conflict.
Measured: 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.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months

Secondary outcomes (4)

Post traumatic stress disorder (PTSD)
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.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Alexithymia
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.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Alcohol Use
Alcohol use will be assessed by the Alcohol Use Disorders Identification Test (AUDIT). AUDIT has 10 questions and the possible responses to each question are scored 0, 1, 2, 3 or 4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Treatment satisfaction
Participants' satisfaction will be assessed with a 4-item measure used in a study conducted by the Treatment of Depression Collaborative Research Program.
Measured: 3 months, 6 months, 9 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 2025Dec 2028

First posted31 Jan 2025
Study start13 Feb 2025
Primary completionDec 2028 (estimated)
Study completionDec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Domestic ViolenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 1,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06803043
Sponsor's protocol ID: H-45014
Other IDs: BPS-2023C1-31039
Status last verified: Sep 2026
First submitted: 27 Jan 2025
Last updated: 1 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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