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NEST: A Group Intervention for Parents With Complex PTSD

2026年8月13日 更新者：Joelle Schenkel、St.Gallen University of Applied Sciences

NEST - Nurturing Emotional Safety in Trauma-Affected Parenting: A Pilot Feasibility and Acceptability Study of a Trauma-Informed Parenting Intervention for Parents With ICD-11 Complex Post-Traumatic Stress Disorder

The goal of this pilot clinical trial is to learn whether NEST, a new trauma-informed group therapy program, is feasible and acceptable for parents with Complex PTSD, a condition that can develop after prolonged or repeated traumatic experiences. Parenting can be especially challenging for people with this condition, and few treatment programs currently address this specific need. The main questions it aims to answer are:

  • Is the NEST group intervention feasible to deliver and acceptable to parents with Complex PTSD?
  • Do parents' trauma-related symptoms and their experience of the parenting role change from before to after the intervention?

Participants will:

  • Complete online questionnaires about trauma-related symptoms and parenting before the group therapy, after it ends, and again three months later
  • Take part in nine weekly 90-minute group therapy sessions, co-led by a member of the study team and a mental health professional from the treatment site
  • Some participants will additionally be invited to a short interview about their experience with the group therapy

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

NEST (Nurturing Emotional Safety in Trauma-Affected Parenting) is a single-arm, multicenter pilot feasibility and acceptability study of a newly developed, manualized trauma-informed parenting group intervention for parents with ICD-11 Complex Post-Traumatic Stress Disorder (CPTSD).

The 9-session group intervention addresses core parenting-related challenges associated with CPTSD, including self-concept and self-efficacy as a parent, emotion regulation within the parent-child relationship, setting boundaries, regulating closeness and distance in the parent-child relationship, and age-appropriate communication with children about the parent's diagnosis. Sessions are trauma-sensitive but not trauma-focused; traumatic memories themselves are not processed within the group. Each group is closed, comprises 6-8 participants, and is co-led by a member of the sponsor's (OST) study team together with a trained psychologist/psychotherapist affiliated with the respective treatment site.

The study is conducted at two clinical sites, the Psychiatric Services Aargau (PDAG) and the Integrated Psychiatry Winterthur (ipw). At each clinical site, the NEST group therapy forms part of participants' regular clinical care and is billed via mandatory health insurance; study-specific procedures are conducted separately by the OST study team. These study-specific procedures consist of self-report questionnaires completed by all participants and a semi-structured qualitative interview completed by a subset of participants after completing the group therapy, to explore their experience of the intervention in greater depth.

研究类型

介入性

注册 (估计的)

32

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 瑞士
    • Canton of Aargau
      • Windisch、Canton of Aargau、瑞士、5210
    • Canton of St. Gallen
      • Sankt Gallen、Canton of St. Gallen、瑞士、9001
        • Eastern Switzerland University of Applied Sciences (OST)
        • 接触：
    • Canton of Zurich
      • Winterthur、Canton of Zurich、瑞士、8400
        • Integrierte Psychiatrie Winterthur (ipw)
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Diagnosis of CPTSD according to ICD-11, confirmed by the treating psychotherapist or psychiatrist
  • Caregiver of at least one child aged 0-18 years (including biological, adoptive, step-, or foster parents and other primary caregivers)
  • Currently receiving individual psychotherapeutic treatment (outpatient or inpatient setting)
  • Age 18 years or older
  • Sufficient German language proficiency to participate in group sessions and complete study questionnaires
  • Ability to provide written informed consent

Exclusion Criteria:

  • Current acute psychosis or severe psychiatric instability requiring immediate intensive treatment
  • Severe cognitive impairment or inability to participate adequately in group-based procedures
  • No current contact with the child
  • Insufficient German language proficiency

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：NEST Group Intervention
Participants receive the NEST group intervention, a manualized, trauma-informed program comprising nine weekly 90-minute group sessions co-led by a member of the study team and a mental health professional from the treatment site. Sessions address parenting-related challenges associated with Complex PTSD, including self-efficacy as a parent, emotion regulation within the parent-child relationship, setting boundaries, and age-appropriate communication with children about the parent's diagnosis. All participants complete self-report questionnaires at three time points (T0, T1, T2) and a subset also completes a semi-structured qualitative interview at T1.
行为的：Trauma-Informed Parenting Group Intervention
The NEST group intervention is a manualized, trauma-informed program consisting of nine weekly 90-minute group sessions, co-led by a member of the study team and a mental health professional from the treatment site. Groups are closed and comprise 6-8 parents. Sessions address parenting-related challenges associated with Complex PTSD, including self-concept and self-efficacy as a parent, emotion regulation within the parent-child relationship, setting boundaries, regulating closeness and distance in the parent-child relationship, and age-appropriate communication with children about the parent's diagnosis. Sessions are trauma-sensitive but not trauma-focused; traumatic memories are not processed within the group.
其他名称：
  • NEST - Nurturing Emotional Safety in Trauma-Affected Parenting

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Feasibility - Enrollment/ Recruitment Rate
大体时间：From day one of recruitment to baseline measurement T0
Feasibility will be assessed descriptively by the number of participants enrolled and the time required to reach the planned sample size.
From day one of recruitment to baseline measurement T0
Feasibility - Retention Rate
大体时间：From enrollment through T1 (approximately 9-10 weeks after enrollment)
Retention will be assessed as the proportion of participants completing the post-intervention assessment (T1). A retention rate ≥70% at T1 is defined a priori as the benchmark for implementation-readiness.
From enrollment through T1 (approximately 9-10 weeks after enrollment)
Feasibility - Intervention Adherence (Session Attendance)
大体时间：From enrollment through completion of the 9-session group intervention (approximately 9-10 weeks after enrollment)
Adherence will be assessed as the proportion of participants attending at least 7 of 9 group sessions. A rate of ≥70% of participants attending at least 7 of 9 sessions is defined a priori as the benchmark for implementation-readiness.
From enrollment through completion of the 9-session group intervention (approximately 9-10 weeks after enrollment)
Feasibility - Protocol Deviations
大体时间：From enrollment through T1 (approximately 9-10 weeks after enrollment)
Feasibility will be assessed descriptively through documentation of protocol deviations occurring during the intervention.
From enrollment through T1 (approximately 9-10 weeks after enrollment)
Acceptability - TFA Questionnaire
大体时间：Post-intervention (T1, approximately 9-10 weeks after enrollment)
Acceptability will be assessed using the generic Theoretical Framework of Acceptability questionnaire (TFA; Sekhon et al., 2022), translated into German and adapted to the group therapy context. The TFA covers seven constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, self-efficacy) plus a general acceptability item. Acceptability is considered sufficient if ratings indicate an overall positive evaluation.
Post-intervention (T1, approximately 9-10 weeks after enrollment)
Acceptability - Qualitative Interviews
大体时间：Post-intervention (T1, approximately 9-10 weeks after enrollment)
A subset of participants will additionally complete a semi-structured qualitative interview (approximately 40-50 minutes) exploring their experience of the intervention. Acceptability is considered sufficient if no substantial recurring concerns regarding safety, burden, or contextual fit emerge in qualitative findings.
Post-intervention (T1, approximately 9-10 weeks after enrollment)

次要结果测量

结果测量
措施说明
大体时间
ICD-11 PTSD and Complex PTSD Symptom Severity
大体时间：Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Assessed using the International Trauma Questionnaire with Clinical Checks (ITQ-CC; Shevlin et al., 2025; German version: Kratzer et al., 2025), which measures ICD-11 PTSD and Complex PTSD symptom severity, including disturbances in self-organisation. Changes in total and/or subscale scores across time points will be analysed descriptively and exploratively.
Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parental Stress (PSS)
大体时间：Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Assessed using the Parental Stress Scale (PSS; Berry & Jones, 1995; German validation: Kölch et al., 2022), an 18-item measure of parenting-related stress across positive and negative dimensions of the parenting role. Changes in total and/or subscale scores across time points will be analysed descriptively and exploratively.
Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parental Self-Efficacy
大体时间：Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Assessed using the Brief Parental Self-Efficacy Scale (BPSES; Woolgar et al., 2025), a 5-item measure of parents' perceived competence and confidence in their parenting role. Changes in total score across time points will be analysed descriptively and exploratively.
Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parenting Practices
大体时间：Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Assessed using the Parenting Scale Short Form (PS-8; Kliem et al., 2018), an 8-item measure of dysfunctional discipline practices, comprising two subscales - laxness and overreactivity - developed and validated in a German representative population sample. Changes in total and/or subscale scores across time points will be analysed descriptively and exploratively.
Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parental Reflective Functioning
大体时间：Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Assessed using the Parental Reflective Functioning Questionnaire (PRFQ; Luyten et al., 2017; German validation: Wildner et al., 2024), a 16-item measure of parents' capacity to mentalise in relation to their child, across three subscales: certainty about mental states, interest and curiosity, and pre-mentalising modes. Changes in total and/or subscale scores across time points will be analysed descriptively and exploratively.
Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Family Emotional Responsiveness
大体时间：Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Assessed using the Family Assessment Device - Affective Responsiveness subscale (FAD-AR; Miller et al., 1985; German validation: Beierlein et al., 2017), a 7-item subscale assessing the quality of emotional responsiveness within the family. Changes in score across time points will be analysed descriptively and exploratively.
Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

St.Gallen University of Applied Sciences

合作者

Swiss National Science Foundation

调查人员

  • 学习椅：Rahel Bachem, PhD、Eastern Switzerland University of Applied Sciences
  • 首席研究员：Joelle Schenkel, MSc、Eastern Switzerland University of Applied Sciences

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2026年8月5日

首先提交符合 QC 标准的

2026年8月13日

首次发布 (实际的)

2026年8月14日

研究记录更新

最后更新发布 (实际的)

2026年8月14日

上次提交的符合 QC 标准的更新

2026年8月13日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2026-01379
  • 222855 (其他赠款/资助编号：Swiss National Science Foundation (SNSF))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

A data sharing plan has not yet been finalized. Quantitative outcome data will likely be made available to other researchers in de-identified form, in line with the Swiss National Science Foundation's Open Science requirements; the specific repository or platform has not yet been determined, though registration on the Open Science Framework (OSF) is planned. Sharing of qualitative interview data is expected to be more limited, given the sensitivity of the content and the increased risk of re-identification in a small qualitative sample. Further details will be specified once the data management and sharing plan has been finalized.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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