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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Feasibility - Enrollment/ Recruitment Rate
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Trauma-Informed Parenting Group Intervention (Behavioral)
结局指标
主要结局
Feasibility - Enrollment/ Recruitment Rate
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- ICD-11 PTSD and Complex PTSD Symptom Severity(Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2))
- Parental Stress (PSS)(Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2))
- Parental Self-Efficacy(Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2))
- Parenting Practices(Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2))
- Parental Reflective Functioning(Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2))
- Family Emotional Responsiveness(Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2))
研究者
Joelle Schenkel
Principle Investigator
St.Gallen University of Applied Sciences