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NEST: A Group Intervention for Parents With Complex PTSD

13 de agosto de 2026 atualizado por: 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

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

32

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Suíça
    • Canton of Aargau
      • Windisch, Canton of Aargau, Suíça, 5210
        • Psychiatrische Dienste Aargau (PDAG)
        • Contato:
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Suíça, 9001
        • Eastern Switzerland University of Applied Sciences (OST)
        • Contato:
    • Canton of Zurich
      • Winterthur, Canton of Zurich, Suíça, 8400
        • Integrierte Psychiatrie Winterthur (ipw)
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: 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.
Outros nomes:
  • NEST - Nurturing Emotional Safety in Trauma-Affected Parenting

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Feasibility - Enrollment/ Recruitment Rate
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
ICD-11 PTSD and Complex PTSD Symptom Severity
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

St.Gallen University of Applied Sciences

Colaboradores

Swiss National Science Foundation

Investigadores

  • Cadeira de estudo: Rahel Bachem, PhD, Eastern Switzerland University of Applied Sciences
  • Investigador principal: Joelle Schenkel, MSc, Eastern Switzerland University of Applied Sciences

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

1 de junho de 2027

Conclusão do estudo (Estimado)

1 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

5 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de agosto de 2026

Primeira postagem (Real)

14 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 2026-01379
  • 222855 (Número de outro subsídio/financiamento: Swiss National Science Foundation (SNSF))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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