NEST: A Group Intervention for Parents With Complex PTSD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt.Gallen University of Applied Sciences
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Trauma-Informed Parenting Group Intervention
BehavioralThe 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.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: NEST Group InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 T02
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)3
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)4
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
St.Gallen University of Applied Sciences
Lead sponsor
Swiss National Science Foundation
Collaborator
Source ClinicalTrials.gov
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