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Набор скоро начнётся NCT07747766

Program for Alleviating Relationship Trauma and Stress for Intimate Partner Violence - Randomized Control Trial

Без фазы С лечением Individuals Who Use Violence Interpersonal Violence

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Program For Alleviating Relationship Trauma and Stress through New Behaviors, DVIT Treatment As Usual (TAU).
Кому может быть актуально
Состояния в реестре: Individuals Who Use Violence, Interpersonal Violence. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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).

Вмешательства

  • Поведенческое Program For Alleviating Relationship Trauma and Stress through New Behaviors
    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 p
  • Поведенческое DVIT Treatment As Usual (TAU)
    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 us

Первичные конечные точки

  • H1.1 - Intervention Feasibility [Срок оценки: From enrollment to the end of treatment at 20 weeks]
Вторичные конечные точки (4)
  • H2.1. - Acceptability [Срок оценки: From enrollment to the end of treatment at 20 weeks]
  • H2.2 -- Satisfaction [Срок оценки: From enrollment to the end of treatment at 20 weeks]
  • H2.3 -- Conflict Tactics [Срок оценки: From enrollment to the end of treatment at 20 weeks]
  • H2.4 -- Aggression Experience [Срок оценки: From enrollment to the end of treatment at 20 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • Cambridge Health Alliance Center for Mindfulness and Compassion — Malden
  • Waterland Counseling — Tumwater

Публикации

  • Tobiasz Veltz, L. (2025). Efficacy of an Online, Group-Based Internal Family Systems (IFS) Intervention on PTSD Symptom Clusters. ProQuest Dissertations & Theses.
  • Ally D, Tobiasz-Veltz L, Tu K, Comeau A, Bumpus C, Blot T, Rice FK, Orr B, Soumerai Rea H, Sweezy M, Schuman-Olivier Z. A pilot study of an online group-based Internal Family Systems intervention for comorbid posttraumatic stress disorder and substance use. Front Psychiatry. 2025 Mar 27;16:1544435. doi: 10.3389/fpsyt.2025.1544435. eCollection 2025. PMID 40212833
  • 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. PMID 38934934
  • 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. PMID 33734765
  • Joss D, Comeau A, Chevannes R, Parry G, Rea HS, Barria J, Bumpus C, Rector A, Rajan A, Rosansky J, Rice FK, Ward MC, Tobiasz Veltz L, Ally D, Rosenberg LG, Sweezy M, Lovas D, Schuman-Olivier Z. A randomized controlled trial of an online group-based internal family systems treatment for posttraumatic stress disorder: The Program for Alleviating and Resolving Trauma and Stress (PARTS) study. Psychol PMID 41609644

Идентификаторы

NCT: NCT07747766 · CHA-IRB-24-25-422

Первоисточники (государственные реестры)

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