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NEST: A Group Intervention for Parents With Complex PTSD

13. august 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

32

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Andre navn:
  • NEST - Nurturing Emotional Safety in Trauma-Affected Parenting

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility - Enrollment/ Recruitment Rate
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
ICD-11 PTSD and Complex PTSD Symptom Severity
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

St.Gallen University of Applied Sciences

Samarbeidspartnere

Swiss National Science Foundation

Etterforskere

  • Studiestol: Rahel Bachem, PhD, Eastern Switzerland University of Applied Sciences
  • Hovedetterforsker: Joelle Schenkel, MSc, Eastern Switzerland University of Applied Sciences

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

5. august 2026

Først innsendt som oppfylte QC-kriteriene

13. august 2026

Først lagt ut (Faktiske)

14. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 2026-01379
  • 222855 (Annet stipend/finansieringsnummer: Swiss National Science Foundation (SNSF))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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.

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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