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NCT Number: NCT07766265

NEST: A Group Intervention for Parents With Complex PTSD

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

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Key information

Conditions

Complex Post-Traumatic Stress Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatrische Dienste Aargau (PDAG), Windisch, Canton of Aargau, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trauma-Informed Parenting Group Intervention

Behavioral

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.

Other names: NEST - Nurturing Emotional Safety in Trauma-Affected Parenting

Primary outcomes

  1. Feasibility - Enrollment/ Recruitment Rate

    Time frame: 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.

  2. Feasibility - Retention Rate

    Time frame: 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.

  3. Feasibility - Intervention Adherence (Session Attendance)

    Time frame: 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.

  4. Feasibility - Protocol Deviations

    Time frame: From enrollment through T1 (approximately 9-10 weeks after enrollment)

    Feasibility will be assessed descriptively through documentation of protocol deviations occurring during the intervention.

  5. Acceptability - TFA Questionnaire

    Time frame: 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.

  6. Acceptability - Qualitative Interviews

    Time frame: 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.

Secondary outcomes

  1. ICD-11 PTSD and Complex PTSD Symptom Severity

    Time frame: 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.

  2. Parental Stress (PSS)

    Time frame: 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.

  3. Parental Self-Efficacy

    Time frame: 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.

  4. Parenting Practices

    Time frame: 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.

  5. Parental Reflective Functioning

    Time frame: 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.

  6. Family Emotional Responsiveness

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joelle Schenkel, MSc

CONTACT

[email protected]

+41 58 257 32 99

Rahel Bachem, PhD

CONTACT

[email protected]

+41 58 257 35 26

Sponsors and collaborators

Lead sponsor

St.Gallen University of Applied Sciences

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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