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Development of the PTSD-iMPACT to Measure PTSD-Related Functional Impairment in Children and Adolescents - A Validation Study in Switzerland and Germany

Key facts

Who runs it
University Children's Hospital, Zurich
Where
Germany and Switzerland11 sites in 2 countriesChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
1,200 people, planned
Started
15 Dec 2025
Planned end
31 Oct 2026
Type of study
Observational, 2 groups
Record updated
26 January 2026

Who can take part

Age
7 years to 18 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

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Who can take part

  • 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)
  • Students between 3rd grade and 18 years / caregivers of kindergarteners and students up until 18 years
  • Sufficient knowledge of the German language

Who cannot take part

  • 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
  • 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

Other criteria

  • Clinical population

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 7 and 18 years old?

This trial has no sites in United States.

It has sites in 2 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • 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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Fit questions
Built from NCT07368166, who can take part
Record updated
26 January 2026