RecruitingNCT07766265ClinicalTrials.gov record

NEST: A Group Intervention for Parents With Complex PTSD

Complex Post-Traumatic Stress Disorder

Ask WCR about this study Official registry record ↗

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 32 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Read the full description

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not applicable
Masking: No masking

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.

Behavioral: Trauma-Informed Parenting Group Intervention

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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.

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.

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.

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.

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.

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.