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Program for Alleviating Relationship Trauma and Stress for Intimate Partner Violence - Randomized Control Trial (PARTS-IPV RCT)

2026年7月31日 更新者:Zev Schuman Olivier、Cambridge Health Alliance
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.

調査の概要

詳細な説明

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).

Secondary Aims H2.1: A secondary aim is overall acceptability of the intervention as measured by the Client Satisfaction Questionnaire (CSQ-8) (Larsen et al., 1979) where for both arms, we expect a mean score of at least 20 out of a total of 32 (H2.1).

H2.2: Intervention satisfaction, as measured by a satisfaction question (would you recommend a friend) will obtain at least a mean of 7 out of 10 (H2.2) in week 20 for both arms.

H2.3: Another 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) and Multidimensional Measure of Emotional Abuse- Restrictive Engulfment (MMEA-RE Subscale) (Murphy & Hoover, 1999). We hypothesize a risk reduction in physical and psychological violence from self-reports in both arms IFS/DVIT-TAU arm (H2.3). In our pilot (N=12), baseline mean of the psychological aggression subscale was 0.51 (SD=0.17), indicating that some participants had very high aggression scores while others did not. In Week 12, the mean was 0.13 (SD=0.12), suggesting that everyone clustered near zero, with a reduction in variability and suggesting a potential for stabilization in risk. Risk reduction in this case is both improvement and stabilization (decreased or stable scores).

For this pilot RCT, we hypothesize a greater risk reduction (decreased/stable scores) of psychological aggression use in the IFS arm compared to DVIT-TAU as measured by the psychological aggression subscale in CTS2 and MMEA-RE Subscale (H2.3).

H2.4: Lastly, in the pilot, we observed declines in the Aggression Experience Sampler (AES) from baseline to week 12. Average baseline scores were 13.97 (SE=0.63) with weekly rates of decline of -0.06 (p-value=0.09), indicating decreases ranging from 0.01 to 0.13 points per week. Based on these pilot findings we hypothesize that the 20-week RCT intervention will produce a weekly decline of -0.04 in AES scores (H2.4).

Exploratory Aims Exploratory outcomes include effects on mechanisms of emotion regulation, decentering, self-critical rumination, and self-compassion.

We hypothesize a greater capacity for decentering (Experiences Questionnaire - Decentering subscale (EQ)), reductions in self-critical rumination, reactivity in interpersonal relationships (OAS2, IRI-SF), as well as an increase in emotion identification and regulation (PAQ-S, Difficulties in Emotion Regulation Scale (DERS)), transcendent experiences (NADA-Bliss subscale), and self-compassion (using Self-Compassion Scale Short Form (SCS-SF)) self report, in IFS PARTS compared to DVIT-TAU at week 12 and 20. Other exploratory aims of the study are to investigate the effects of the intervention on general mental health including posttraumatic stress disorder, depression, anxiety (Achtyes et al., 2015; Guinart et al., 2021), and substance use (Craving Scale, AUDIT-C).

研究の種類

介入

入学 (推定)

48

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Massachusetts
      • Malden、Massachusetts、アメリカ、02148
        • Cambridge Health Alliance Center for Mindfulness and Compassion
        • コンタクト:
    • Washington
      • Tumwater、Washington、アメリカ、98512

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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 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.

Exclusion Criteria:

  • 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.)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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).

The experiential protocol includes 15 minutes of themed curriculum and 45 minutes of experiential exercises, e.g., going inside meditation, centering practice, witnessing their own parts, psychodrama, speaking for parts exercises, finding parts in the body, etc. In addition, participants will have 30 minutes to speak in the group about their experience and review the manual focused on new coping strategies and behaviors. We will ask participants to keep a journal to write down observations and parts they notice during the week and ask them to bring the journal and manual we send to them to the group so they can record information they remember after exercises.

All participants also will be scheduled to have approximately six to nine standard clinical one-hour sessions with an individual IFS trained counselor (at least Level 1 IFS trained) during their time in the program, with an average of one-two sessions per month (6-9 total individual sessions).

他の名前:
  • Program For Alleviating Relationship Trauma and Stress - InterPersonal Violence
アクティブコンパレータ: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.
Treatment As Usual (TAU) for people who use violence in interpersonal and domestic relationships. In WA state currently, these treatments are usually 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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
H1.1 - Intervention Feasibility
時間枠: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)
From enrollment to the end of treatment at 20 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
H2.1. - Acceptability
時間枠:From enrollment to the end of treatment at 20 weeks
Mean score of 20 on the Client Satisfaction Questionnaire (CSQ-8) general acceptability item A secondary aim is overall acceptability of the intervention as measured by the Client Satisfaction Questionnaire (CSQ-8) (Larsen et al., 1979) where for both arms, we expect a mean score of at least 20 out of a total of 32 (H2.1)
From enrollment to the end of treatment at 20 weeks
H2.2 -- Satisfaction
時間枠:From enrollment to the end of treatment at 20 weeks
Intervention satisfaction, as measured by a satisfaction question (would you recommend a friend) will obtain at least a mean of 7 out of 10 (H2.2) in week 20 for both arms Mean >7.0 of 10 on willingness to refer a friend on Satisfaction Questionnaire
From enrollment to the end of treatment at 20 weeks
H2.3 -- Conflict Tactics
時間枠:From enrollment to the end of treatment at 20 weeks
Investigate the potential effects of the intervention on the Revised Conflict Tactics Scale (CTS2) (Straus et al., 1996; Chapman & Gillespie, 2019) and Multidimensional Measure of Emotional Abuse- Restrictive Engulfment (MMEA-RE Subscale) (Murphy & Hoover, 1999). We hypothesize a risk reduction in physical and psychological violence from self-reports in both arms IFS/DVIT-TAU arm (H2.3). In our pilot (N=12), baseline mean of the psychological aggression subscale was 0.51 (SD=0.17), indicating that some participants had very high aggression scores while others did not. In Week 12, the mean was 0.13 (SD=0.12), suggesting that everyone clustered near zero, with a reduction in variability and suggesting a potential for stabilization in risk. Risk reduction in this case is both improvement and stabilization (decreased or stable scores).
From enrollment to the end of treatment at 20 weeks
H2.4 -- Aggression Experience
時間枠:From enrollment to the end of treatment at 20 weeks
in the pilot PARTS IPV study, we observed declines in the Aggression Experience Sampler (AES) from baseline to week 12. Average baseline scores were 13.97 (SE=0.63) with weekly rates of decline of -0.06 (p-value=0.09), indicating decreases ranging from 0.01 to 0.13 points per week. Based on these pilot findings we hypothesize that the 20-week RCT intervention will produce a weekly decline of -0.04 in AES scores (H2.4)
From enrollment to the end of treatment at 20 weeks

その他の成果指標

結果測定
メジャーの説明
時間枠
Exploratory Aim - mechanisms of emotion regulation, decentering, self-critical rumination, and self-compassion
時間枠:From enrollment to the end of treatment at 20 weeks

Exploratory outcomes include effects on mechanisms of emotion regulation, decentering, self-critical rumination, and self-compassion.

We hypothesize a greater capacity for decentering (Experiences Questionnaire - Decentering subscale (EQ)), reductions in self-critical rumination, reactivity in interpersonal relationships (OAS2, IRI-SF), as well as an increase in emotion identification and regulation (PAQ-S, Difficulties in Emotion Regulation Scale (DERS)), transcendent experiences (NADA-Bliss subscale), and self-compassion (using Self-Compassion Scale Short Form (SCS-SF)) self report, in IFS PARTS compared to DVIT-TAU at week 12 and 20. Other exploratory aims of the study are to investigate the effects of the intervention on general mental health including posttraumatic stress disorder, depression, anxiety (Achtyes et al., 2015; Guinart et al., 2021), and substance use (Craving Scale, AUDIT-C).

From enrollment to the end of treatment at 20 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Zev Schuman-Olivier, MD、Center for Mindfulness & Compassion - Cambridge Health Alliance

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2027年7月31日

研究の完了 (推定)

2027年7月31日

試験登録日

最初に提出

2026年7月31日

QC基準を満たした最初の提出物

2026年7月31日

最初の投稿 (実際)

2026年8月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月5日

QC基準を満たした最後の更新が送信されました

2026年7月31日

最終確認日

2026年7月1日

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