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临床试验/NCT06765122
NCT06765122进行中(未招募)不适用

Program for Alleviating and Reducing Trauma and Stress for Intimate Partner Violence

Cambridge Health Alliance2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年1月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
24
试验地点
2
主要终点
Feasibility of Intervention

研究概览

简要总结

This research study investigates the feasibility and acceptability 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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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 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 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.

研究组 & 干预措施

PARTS-NB

Experimental

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".

干预措施: Program for Alleviating Relationship Trauma and Stress through New Behaviors (PARTS-NB) (Behavioral)

结局指标

主要结局

Feasibility of Intervention

时间窗: At 12 and 20 weeks

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.

次要结局

  • Acceptability of Intervention(At 12 and 20 weeks)
  • Intervention Satisfaction(At 12 and 20 weeks)
  • Revised Conflict Tactics Scale (CTS2)(Change from Baseline to 12 and 20 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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