- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06765122
Program for Alleviating and Reducing Trauma and Stress for Intimate Partner Violence (PARTS-IPV)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Our program is adapted from the original PARTS (Program For Alleviating and Reducing Trauma and Stress). And will include unique and specific elements for People who Use Violence (PUV) in intimate relationships. PARTS-IPV is structured in three phases. Phase I is 4-weeks of 120 minutes of weekly group-based sessions. This phase introduces the model and creates a "brave container" to address any ambivalence towards the program. Phase II lasts 8-weeks, maintaining the 120 minutes of weekly group-based sessions. This second phase focuses on "unblending" through working with Parts and connecting with Self. The final phase, Phase III runs 8 weeks and consists of weekly 120-minute group sessions focused "unburdening". Throughout the intervention, individual sessions will be help with an IFS-trained clinician at a frequency of around once a month for a total of 6 individual sessions. These sessions will focus on enhancing group participation, providing space for trauma counseling and unburdening, addressing negative beliefs or concerns that may arise about group, and providing insights into person reasons for the use of violence in intimate relationships. Participants may have up to 3 additional sessions to make up any missed group sessions.
This project is an important and timely pilot study. Previous reviews of interventions suggest there is a gap in effective interventions to treat IPV for those with trauma backgrounds (Cheng et al., 2021; Travers et al. 2021). PARTS1, PARTS2 and PARTS SUD have all demonstrated effective reductions in PTSD symptoms and enhanced emotion regulation and self-related processing (Comeau et al. 2024; Ally et al., submitted; Schuman-Olivier et al., in progress). The protocol's methodology follows previous intimate partner violence studies, incorporating verbal consent and partner inclusion, while employing rigorously implemented informed consent procedures and gold-standard measures to enhance the likelihood of success and publication. By incorporating the Difficulties in Emotion Regulation (DERS) and a WHO-5 for quality of life, we aim to address gaps in understanding the comprehensive factors contributing to intimate partner violence.
Primary Aim
The primary aim of this protocol is feasibility of a live-online version of the PARTS program. Feasibility is defined in two ways: intervention-based feasibility: 70% of participants completing at least 67% (e.g., 8/12) of the first 12 groups, study-protocol feasibility as 67% or more of participants completing week-20 study assessments (H1.1).
Secondary Aims The secondary aims are to examine the overall acceptability of the intervention as measured by the Client Satisfaction Questionnaire (CSQ-8) (Larsen et al., 1979) with a mean score of at least 20 out of a total of 32 (H2.1), and intervention satisfaction as measured by a satisfaction question (would you recommend a friend) obtaining at least a mean of 7 out of 10 (H2.2).
A third secondary aim of the study is to investigate the potential effects of the intervention on the Revised Conflict Tactics Scale (CTS2) (Straus et al., 1996; Chapman & Gillespie, 2019). We hypothesize a risk reduction in physical and psychological violence, with an a priori expectation of obtaining a small to moderate effect size (Cohen's d: 0.2-0.5) from self-reports (H2.3). This effect size aligns with a comparably powered study, Strength at Home, among court-mandated civilians (N=23), which reported moderate effect sizes on CTS2.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Malden, Massachusetts, United States, 02148
- Cambridge Health Alliance Center for Mindfulness and Compassion
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Washington
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Tumwater, Washington, United States, 98512
- Waterland Counseling
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Must be male-identifying or prefer to be in a male-identifying group; Must be a resident of Washington state; Must be court-referred to a treatment program for using violence with an intimate partner; Have sufficient English fluency and literacy skills to understand the consent process, procedures and questionnaires and have the ability to provide written informed consent; Have access to the internet and an electronic device with adequate data capacity; to complete questionnaires online and attend online video conference groups; Must be available and willing to attend 17 out of 20 scheduled online group sessions; and Must be available and willing to complete the online computerized assessments and phone interviews.
Exclusion Criteria:
Insufficiently stable housing or internet connection to be able to join at least 17 sessions; Current participation in another experimental research study; Expected medical hospitalization in the next six months from study enrollment period; Current or expected physical incarceration in the next six months from study enrollment period; Inpatient hospitalization for mental health, substance use, suicide attempt or self-harm within past three months; Inability to participate safely in the study intervention and without disrupting the group (in the opinion of principal investigator OR meeting any of the following criteria) Past year history of a psychotic disorder or clinician confirmed active psychosis assessed by the Structured Clinical Interview for DSM-5 (SCID-5); Bipolar I disorder history or current severe level of mania assessed by the Structured Clinical Interview for DSM-5 (SCID-5); Acute suicidality with intent will be excluded from the study (Structured Clinical Interview for DSM-5 [SCID-5]); High levels of Psychopathy as defined by self-report psychopathy checklist (SRP-4); Self-injurious behavior in past three months will require clinical assessment prior to participation in the program; Acute homicidality with plan and/or intent; Severe personality disorder with clinical history that would suggest potential disruptions within the group as assessed by the Structured Clinical Interview for DSM-5 (SCID-5); and/or Inability to join a group without intoxication.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PARTS-NB
All study participants will be in the PARTS-NB arm and go through the treatment program called "Program for Alleviating Relationship Trauma and Stress through New Behaviors".
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PARTS-NB (Program For Alleviating Relationship Trauma and Stress through New Behaviors) is a group-based program for people who use violence and aggression in intimate relationships.
Phase I is 4-weeks of 120 minutes of weekly group-based sessions focused on clarifying the way parts work in the mind, increasing inner compassion and emotion regulation, and explaining the role of trauma and stress in substance use and the use of violence in relationships.
Phase II lasts 8-weeks, maintaining the 120 minutes of weekly group-based sessions.
This phase introduces the model and focuses on practicing "unblending," helping individuals gain awareness and acceptance of internal and external experiences.
The final phase, Phase III runs 8 weeks and consists of weekly 120-minute group sessions which addresses and releases trauma-based beliefs and experiences through a process called "unburdening."
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Intervention
Time Frame: At 12 and 20 weeks
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Intervention-based feasibility: 67% (e.g., 8/12) of participants completing at least 67% (e.g., 8/12) of the first 12 groups, study protocol feasibility as 67% (e.g., 8/12) or more of participants completing week-20 study assessments.
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At 12 and 20 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of Intervention
Time Frame: At 12 and 20 weeks
|
Mean score of 20 on the Client Satisfaction Questionnaire (CSQ-8) general acceptability item.
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At 12 and 20 weeks
|
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Intervention Satisfaction
Time Frame: At 12 and 20 weeks
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Mean >7.0 of 10 on willingness to refer a friend on Satisfaction Questionnaire
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At 12 and 20 weeks
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Revised Conflict Tactics Scale (CTS2)
Time Frame: Change from Baseline to 12 and 20 weeks
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A 78-item self-report scale measuring conflict tactics that are used in relationships
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Change from Baseline to 12 and 20 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Zev Schuman-Olivier, MD, Cambridge Health Alliance Center for Mindfulness and Compassion
Publications and helpful links
General Publications
- Taft CT, Franz MR, Cole HE, D'Avanzato C, Rothman EF. Examining strength at home for preventing intimate partner violence in civilians. J Fam Psychol. 2021 Sep;35(6):857-862. doi: 10.1037/fam0000732. Epub 2021 Mar 18.
- Comeau A, Smith LJ, Smith L, Soumerai Rea H, Ward MC, Creedon TB, Sweezy M, Rosenberg LG, Schuman-Olivier Z. Online group-based internal family systems treatment for posttraumatic stress disorder: Feasibility and acceptability of the program for alleviating and resolving trauma and stress. Psychol Trauma. 2024 Dec;16(Suppl 3):S636-S640. doi: 10.1037/tra0001688. Epub 2024 Jun 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHA-IRB-24-25-352
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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