An interventional study of Trauma-Informed Parenting Group Intervention in Complex Post-Traumatic Stress Disorder, sponsored by St.Gallen University of Applied Sciences. Recruiting at 3 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by St.Gallen University of Applied Sciences · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 32 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →St.Gallen University of Applied Sciences is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: 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.
Also known as: NEST - Nurturing Emotional Safety in Trauma-Affected Parenting
Feasibility - Enrollment/ Recruitment Rate
Feasibility will be assessed descriptively by the number of participants enrolled and the time required to reach the planned sample size.
Time frame: From day one of recruitment to baseline measurement T0
Feasibility - Retention Rate
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.
Time frame: From enrollment through T1 (approximately 9-10 weeks after enrollment)
Feasibility - Intervention Adherence (Session Attendance)
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.
Time frame: From enrollment through completion of the 9-session group intervention (approximately 9-10 weeks after enrollment)
Feasibility - Protocol Deviations
Feasibility will be assessed descriptively through documentation of protocol deviations occurring during the intervention.
Time frame: From enrollment through T1 (approximately 9-10 weeks after enrollment)
Acceptability - TFA Questionnaire
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.
Time frame: Post-intervention (T1, approximately 9-10 weeks after enrollment)
Acceptability - Qualitative Interviews
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.
Time frame: Post-intervention (T1, approximately 9-10 weeks after enrollment)
ICD-11 PTSD and Complex PTSD Symptom Severity
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.
Time frame: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parental Stress (PSS)
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.
Time frame: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parental Self-Efficacy
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.
Time frame: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parenting Practices
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.
Time frame: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parental Reflective Functioning
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.
Time frame: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Family Emotional Responsiveness
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.
Time frame: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Plan to share: Undecided — 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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