NEST: A Group Intervention for Parents With Complex PTSD

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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

Primary outcome measure(s)

• Feasibility - Enrollment/ Recruitment Rate — 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.
• Feasibility - Retention Rate — 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.
• Feasibility - Intervention Adherence (Session Attendance) — 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.
• Feasibility - Protocol Deviations — From enrollment through T1 (approximately 9-10 weeks after enrollment)
  Feasibility will be assessed descriptively through documentation of protocol deviations occurring during the intervention.
• Acceptability - TFA Questionnaire — 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.
• Acceptability - Qualitative Interviews — 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.

Trial sites (3)

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