Post-Traumatic Stress Disorder (PTSD) Clinical Trials

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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

Status: Recruiting
Location: See all (11) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Germany
Traumaambulanz, Universitätsklinikum Aachen
NOT_YET_RECRUITING
Aachen
Otto-Friedrich-Universität Bamberg
NOT_YET_RECRUITING
Bamberg
Lehrstuhl für Klinische Psychologie und Kinder- und Jugendlichenpsychotherapie, Katholische Universität Eichstätt-Ingolstadt
NOT_YET_RECRUITING
Eichstätt
Zentrum für Psychotherapie Bodensee (apb)
NOT_YET_RECRUITING
Konstanz
Kinder- und Jugendlichen-Psychotherapie-Ambulanz (KJ-PAM) Marburg
NOT_YET_RECRUITING
Marburg
Universitätsklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie Carl von Ossietzky Universität Oldenburg
NOT_YET_RECRUITING
Oldenburg
Child and Adolescent Psychiatry Ulm University
NOT_YET_RECRUITING
Ulm
Switzerland
Child and Adolescent Psychiatric Services Thurgau
RECRUITING
Frauenfeld
• Parent-Child Consultation 0-5 of The Child and Adolescent Psychiatric Services St. Gallen
RECRUITING
Sankt Gallen
Cantonal Hospital Winterthur
RECRUITING
Winterthur
University Children's Hospital Zurich
RECRUITING
Zurich
Contact Information
Primary
Lasse Bartels, Dr.
lasse.bartels@kispi.uzh.ch
+41 44 249 56 60
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 1200
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Center for Psychotherapie Bodensee (apb), Konstanz, Deutschland, Cantonal Hospital Winterthur, Switzerland, University Clinic for Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany, Child and Adolescent Psychiatric Services St. Gallen, Switzerland, Outpatient clinic for trauma, Clinic for Psychiatry, Psychosomatics, and Psychotherapy for Children and Adolescents, RHTW Aachen, Aachen, Deutschland, Psychotherapeutic outpatient clinic for children and adolescents, Catholic University Eichstätt-Ingolstadt, Germany, Child and Adolescent Outpatient Clinic (KJ-PAM), Universität Marburg, Marburg, Deutschland, Psychotherapeutic outpatient clinic for children and adolescents, University of Bamberg, Bamberg, Germany, Child and Adolescent Psychiatric Services Thurgau, Switzerland
Leads: University Children's Hospital, Zurich

This content was sourced from clinicaltrials.gov