Program for Alleviating Relationship Trauma and Stress for Intimate Partner Violence - Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- H1.1 - Intervention Feasibility
研究概览
简要总结
This research study investigates the feasibility of a randomized control trial of a group-based treatment program for reducing stress, trauma, substance use, and use of violence among individuals who were court-mandated to attend a program after committing an act(s) of domestic violence. The study is in a 2-arm design with an intervention group and a control group.
详细描述
We previously tested a pilot program called PARTS-NB (Program For Alleviating Relationship Trauma and Stress- New Behaviors), an adaptation of the original PARTS Program and a study registered under the name of PARTS IPV (NCT06765122). The pilot program included unique and specific elements for People who Use Violence (PUV) in intimate relationships. Preliminary results from the PARTS IPV pilot suggest that intervention-based feasibility was met, with a total of 13 individuals attending at least 1 group and 12/13 individuals attending at least 8/12 of the first 12 groups. Mean acceptability was 26 (SD =3.4) meeting the acceptability criteria for the intervention at week 12. Moreover, individuals in the pilot PARTS IPV had overall declines in their aggression scales, minor psychological aggression (CTS2) and trended towards lower values and less variance in severe psychological aggression (CTS2). Interestingly, we also observed reductions in the frequency of individuals having six or more drinks (Question 3, AuditC).
Given these results, this project is an important and timely study with high-quality pilot randomized control clinical trial design. The methodology aligns closely with the specific aims described in this application and uses several innovative features and some carefully implemented gold-standard measures to ensure a high likelihood of success and publication. This will be the first RCT testing an intensive model of IFS group therapy designed specifically for those who use violence within intimate partner relationships with concurrent intermittent individual meetings for ongoing evaluation and support.
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 for Substance Use Disorder (PARTS SUD) have all demonstrated enhanced emotion regulation and self-related processing (Comeau et al. 2024; Ally et al. 2025; Joss et al. 2026). 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. While CBT IPV interventions vary in length (e.g., Strength at Home (SAH) groups are 12-weeks, standard state programs such as the psychoeducation program in the State of Washington are 26 sessions), we will use a phased approach that will run a total of 20 weeks with 20 group sessions and 6-9 individual sessions.
Primary Aims The primary aim of this study is to conduct a NIH Stage III hybrid "real-world implementation" study assessing the feasibility and acceptability (Nathan, 2007; Onken et al., 2014) of an Internal Family Systems intensive group program (Program for Alleviating and Reducing Trauma and Stress - IPV) (PARTS-IPV Phase 2) versus domestic violence treatment intervention treatment as usual (DVIT-TAU) control group on individuals mandated for treatment. We have two primary aims for this pilot RCT protocol: feasibility and acceptability.
Feasibility is defined in two ways: intervention-based feasibility: in both arms, we expect 70% of participants completing at least 67% (e.g., 8/12) of the first 12 groups. For study-protocol feasibility we do not expect differences in the arms but expect each arm to obtain overall 67% or more of participants completing week-20 study assessments (H1.1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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 at least 17 out of 20 scheduled online group sessions; and
- •Must be available and willing to complete the online computerized assessments, and phone interviews.
排除标准
- •Insufficiently stable housing or internet connection to be able to join at least 17 group 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 (excluding house arrest or other forms of electronic monitoring) 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;
- •Inability to join a group without intoxication.
- •Prior experience or exposure with Internal Family Systems (e.g. IFS therapy, IFS groups or retreats, current IFS practice, etc.)
研究组 & 干预措施
PARTS-NB Arm
Participants (N=24 anticipated) randomly allocated to this arm with undergo an IFS-based intervention called PARTS-NB, which curriculum is adapted from the original PARTS program and encompasses a mix of weekly group sessions (120 minutes each) for 20 weeks and individual IFS therapy sessions (minimum 6, and up to 9).
干预措施: Program For Alleviating Relationship Trauma and Stress through New Behaviors (Behavioral)
DVIT-TAU Arm
The control group (N=24 anticipated) will follow Treatment As Usual (TAU) for people who use violence in interpersonal and domestic relationships. Currently in WA state, these treatments are a mix of elements from Cognitive Behavioral Therapy (CBT), Duluth Model, and/or Moral Reconation Therapy (MRT). Participants in this group will not be exposed to IFS during TAU to preserve the integrity of the study design. The number of individual counseling sessions during TAU will be tracked, but it can vary based on need in the treatment as usual modalities.
干预措施: DVIT Treatment As Usual (TAU) (Behavioral)
结局指标
主要结局
H1.1 - Intervention Feasibility
时间窗: From enrollment to the end of treatment at 20 weeks
70% of participants attend 67% of group sessions Study feasibility: 70% of participants complete of post study assessments For study-protocol feasibility we do not expect differences in the arms but expect each arm to obtain overall 67% or more of participants completing week-20 study assessments (H1.1)
次要结局
- H2.1. - Acceptability(From enrollment to the end of treatment at 20 weeks)
- H2.2 -- Satisfaction(From enrollment to the end of treatment at 20 weeks)
- H2.3 -- Conflict Tactics(From enrollment to the end of treatment at 20 weeks)
- H2.4 -- Aggression Experience(From enrollment to the end of treatment at 20 weeks)
研究者
Zev Schuman Olivier
Director of the Center for Mindfulness and Compassion
Cambridge Health Alliance