Development of the PTSD-iMPACT to Measure PTSD-Related Functional Impairment in Children and Adolescents - A Validation Study in Switzerland and Germany
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 11
- 主要终点
- PTSD-iMPACT (newly developed questionnaire)
研究概览
简要总结
Population-based and clinical studies indicate that a substantial proportion of children and adolescents are exposed to one or more potentially traumatic events (PTEs) Approximately 16 % of those affected by childhood trauma go on to develop post-traumatic stress disorder (PTSD), with an even higher proportion experiencing subclinical levels of post-traumatic stress symptoms (PTSS). In Switzerland, over half of adolescents report exposure to at least one PTE, with 4.2 % meeting diagnostic criteria for PTSD. PTSD frequently impacts young people's social and educational functioning, often impairing their ability to engage in everyday life activities that are important or meaningful to them. Although the psychological consequences of PTSD are well documented, there is limited empirical understanding of how PTSS specifically affects day-to-day functioning in young people.
A key reason for this gap is the absence of a validated instrument specifically designed to assess PTSD-related functional impairment in children and adolescents. To address this need, the PTSD-iMPairment in Adolescent & Children's Capacity for Thriving (PTSD-iMPACT) measure was developed. This tool aims to systematically assess the extent of PTSD-related functional impairment in children and adolescents across key life domains, such as family, friends, school, apprenticeship, hobbies or media use.
The overall aim of this study is to evaluate the psychometric properties of the PTSD-iMPACT questionnaire in a clinical and in a non-clinical sample and to provide an internationally applicable standard instrument for the assessment of PTSD-related functional impairment in trauma-exposed children and adolescents.
In the long term, the aim is to ensure that the care and support provided to children and adolescents who experience difficulties in their daily lives due to post-traumatic stress symptoms are sustainably monitored and improved.
详细描述
The PTSD-iMPACT is designed to assess the severity of PTSD-related functional impairment across specific activities and tasks in multiple life domains.
The development of the PTSD-iMPACT followed a two-phase process. First, a systematic review was conducted to examine how existing PTSD-specific instruments, diagnostic interview modules, and general measures of functional impairment assess PTSD-related impairment in youth. The review revealed considerable heterogeneity in the domains assessed, frequent reliance on dichotomous response options, inconsistent scoring procedures, and a general lack of psychometric validation. Many instruments assessed functioning only at a global level, without capturing the specific nature or severity of difficulties within each domain. Furthermore, most relied on face validity and lacked demonstrated content validity, highlighting the need for a more methodologically sound tool.
In the second phase, qualitative interviews and focus groups were conducted (Cantonal Ethics Committee Zurich, Switzerland; BASEC-ID 2023-01290) with trauma-exposed children and adolescents (aged 7-18) who presented with at least moderate PTSS, as well as caregivers of children aged 1-18 with similar symptom profiles. Participants were recruited through clinical and social service settings. Data were analyzed using qualitative content analysis to identify relevant domains of functioning and specific challenges within those domains affected by PTSS. This conceptual framework informed item generation for the PTSD-iMPACT. Item refinement was carried out with input from clinical and research experts.
The final instrument includes both a self-report and caregiver-report version for children and adolescents aged 7-18, as well as a caregiver-version for children aged 3-6. It is designed to enhance clinical decision-making, improve diagnostic accuracy, and support outcome monitoring across diverse international contexts.
To ensure that the PTSD-iMPACT functions as a psychometrically sound and clinically meaningful assessment tool, validation across both clinical and non-clinical populations is essential and is therefore carried out in the present study. This process will allow for the evaluation of sensitivity, specificity, and broader applicability across varying levels of functional impairment, thereby supporting its use in both research and routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical population
- •Inclusion Criteria:
- •Use of (mental) health services at a participating study center.
- •Children and adolescents between 7 and 18 years / caregivers of children and adolescents between 3 and 18 years
- •Sufficient knowledge of the German language
- •Signed consent form (7-18 years: patient and caregiver; 3-6 years: caregivers)
排除标准
- •Children and adolescents under 7 or over 18 years / caregivers of children and adolescents under 3 or over 18 years
- •Not sufficient knowledge of the German language
- •No signed consent form (7-18 years: patient and/or caregiver; 3-6 years: caregivers)
- •Non-clinical population Only recruited in Switzerland.
- •Inclusion Criteria:
- •Students between 3rd grade and 18 years / caregivers of kindergarteners and students up until 18 years
- •Sufficient knowledge of the German language
- •Exclusion Criteria:
- •Students 2nd grade or lower and over 18 years / caregivers of children not yet in Kindergarten and students over 18 years
- •No sufficient knowledge of the German language
研究组 & 干预措施
Clinical population
The minimum sample size per Switzerland and Germany, respectively, will be n≥100 per cohort (n≥100 trauma-exposed children and adolescents aged 7-18, n≥100 caregivers of trauma-exposed children and adolescents aged 7-18; n≥100 caregivers of trauma-exposed children aged 3-6 years) to enable separate psychometric analyses for each country on a sufficient empirical basis. This corresponds, for each national sample (Switzerland and Germany), to a minimum of 100 trauma-exposed children and adolescents and a total of at least 200 caregivers. The maximum intended sample size is double these numbers. Consecutive data collection will continue at the participating study centers for 13 months (December 2025 - October 2026). As far as possible, every patient and/or caregiver who visits the participating clinical institutions or medical settings for the first time (inpatient or outpatient) will be invited to participate in the study.
Non-clinical population
Only in Switzerland, a non-clinical sample will be recruited. The minimum sample size will be n≥100 trauma-exposed children and adolescents, and caregivers of trauma-exposed children and adolescents, per school type (Kindergarten [only caregivers], Primarschule [3rd grade or higher], Sekundarstufe [students and caregivers], Gymnasium [students until 18 and their caregivers], and Berufsschule [until 18 years]).
Based on epidemiological data indicating that approximately 55% of Swiss adolescents report at least one potentially traumatic event, we plan to recruit a total minimum sample size of 200 children and adolescents and 200 caregivers in primary and secondary schools. An equally sized sample of 200 adolescents and 200 caregivers will be recruited in grammar schools (Gymnasium). In Berufsschulen, we aim to include 200 adolescents, while caregivers will not participate. For kindergartens, the recruitment target is 200 caregivers.
结局指标
主要结局
PTSD-iMPACT (newly developed questionnaire)
时间窗: Baseline and Follow-up two weeks later. In nonclinical samples, data will be only assessed at Baseline.
Children and Adolescents aged 7 to 18 years: Self-report and caregiver-report. The following domains are assessed: * Family - Living together (5 items) * Family - Contact without living together (4 items) * Friends/Peers (5 items) * School (5 items) * Work/Vocational Program/Apprenticeship (5 items) * Hobbies/Fun (3 items) * Dating/Romantic Relationships (3 items) * Getting around and joining in (2 items) * Health/Self-Care (5 items) * Media Use (1 item) Children aged 3 to 6 years: Caregiver-report. The following domains are assessed: * Family - Living together (5 items) * Family - Contact without living together (4 items) * Friends/Peers (4 items) * Daycare/Preeschool/Kindergarten/School (3 items) * Playing/Fun (2 items) * Public places (1 item) * Health/Self-Care (2 items) * Media Use (1 item)
次要结局
- Potentially traumatic events (PTE) (Children and adolescents aged 7 to 18 years)(Baseline and Follow-up two weeks later. In nonclinical samples, data will be only assessed at Baseline.)
- PTSD (Children and adolescents aged 7 to 18 years)(Baseline and Follow-up two weeks later. In nonclinical samples, data will be only assessed at Baseline.)
- Depression (Children and adolescents aged 7 to 18 years)(Baseline)
- Anxiety (Children and adolescents aged 7 to 18 years)(Baseline)
- Quality of life (Children and adolescents aged 7 to 18 years)(Baseline)
- Functioning (Children and adolescents aged 7 to 18 years)(Baseline)
- Adjustment disorder (both children 3-6 and 7-18years)(Baseline and Follow-up two weeks later. In nonclinical samples, data will be only assessed at Baseline.)
- Regulation of Emotional Expression (Children and adolescents aged 7 to 18 years)(Baseline)
- Potentially traumatic events (Children aged 3 to 6 years)(Baseline and Follow-up two weeks later. In nonclinical samples, data will be only assessed at Baseline.)
- PTSD (Children aged 3 to 6 years)(Baseline and Follow-up two weeks later. In nonclinical samples, data will be only assessed at Baseline.)
- Behavioral Problems (Children aged 3 to 6 years)(Baseline)
- Quality of Life (Children aged 3 to 6 years)(Baseline)
- Stressor-related Thoughts and Worries (Children aged 3 to 6 years)(Baseline)
- PTSD (Caregiver of children aged 3 to 6)(Baseline and Follow-up two weeks later. In nonclinical samples, data will be only assessed at Baseline.)
- Trauma Exposure (Caregiver of children aged 3 to 6)(Baseline and Follow-up two weeks later. In nonclinical samples, data will be only assessed at Baseline.)