NEST: A Group Intervention for Parents With Complex PTSD
2026년 8월 13일 업데이트: Joelle Schenkel, St.Gallen University of Applied Sciences
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
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
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
32
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Joelle Schenkel, MSc
- 전화번호: +41 58 257 32 99
- 이메일: joelle.schenkel@ost.ch
연구 연락처 백업
- 이름: Rahel Bachem, PhD
- 전화번호: +41 58 257 35 26
- 이메일: rahel.bachem@ost.ch
연구 장소
-
-
Canton of Aargau
-
Windisch, Canton of Aargau, 스위스, 5210
- Psychiatrische Dienste Aargau (PDAG)
-
연락하다:
- Nina Schweinfurth-Keck, MD
- 전화번호: +41 56 481 61 81
- 이메일: nina.schweinfurth-keck@pdag.ch
-
-
Canton of St. Gallen
-
Sankt Gallen, Canton of St. Gallen, 스위스, 9001
- Eastern Switzerland University of Applied Sciences (OST)
-
연락하다:
- Joelle Schenkel, MSc
- 전화번호: +41 58 257 32 99
- 이메일: joelle.schenkel@ost.ch
-
-
Canton of Zurich
-
Winterthur, Canton of Zurich, 스위스, 8400
- Integrierte Psychiatrie Winterthur (ipw)
-
연락하다:
- Jochen Binder, MD
- 전화번호: +41 52 264 38 60
- 이메일: jochen.binder@ipw.ch
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
1
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Feasibility - Enrollment/ Recruitment Rate
기간: 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.
|
From day one of recruitment to baseline measurement T0
|
|
Feasibility - Retention Rate
기간: 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.
|
From enrollment through T1 (approximately 9-10 weeks after enrollment)
|
|
Feasibility - Intervention Adherence (Session Attendance)
기간: 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.
|
From enrollment through completion of the 9-session group intervention (approximately 9-10 weeks after enrollment)
|
|
Feasibility - Protocol Deviations
기간: From enrollment through T1 (approximately 9-10 weeks after enrollment)
|
Feasibility will be assessed descriptively through documentation of protocol deviations occurring during the intervention.
|
From enrollment through T1 (approximately 9-10 weeks after enrollment)
|
|
Acceptability - TFA Questionnaire
기간: 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.
|
Post-intervention (T1, approximately 9-10 weeks after enrollment)
|
|
Acceptability - Qualitative Interviews
기간: 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.
|
Post-intervention (T1, approximately 9-10 weeks after enrollment)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
ICD-11 PTSD and Complex PTSD Symptom Severity
기간: 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.
|
Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
|
|
Parental Stress (PSS)
기간: 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.
|
Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
|
|
Parental Self-Efficacy
기간: 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.
|
Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
|
|
Parenting Practices
기간: 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.
|
Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
|
|
Parental Reflective Functioning
기간: 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.
|
Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
|
|
Family Emotional Responsiveness
기간: 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.
|
Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 연구 의자: Rahel Bachem, PhD, Eastern Switzerland University of Applied Sciences
- 수석 연구원: Joelle Schenkel, MSc, Eastern Switzerland University of Applied Sciences
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 8월 1일
기본 완료 (추정된)
기본 완료
2027년 6월 1일
연구 완료 (추정된)
연구 완료
2027년 6월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 5일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 13일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 14일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 13일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2026-01379
- 222855 (기타 보조금/기금 번호: Swiss National Science Foundation (SNSF))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .