PTSD-iMPACT: measuring how PTSD affects daily functioning in children and adolescents
Development of the PTSD-iMPACT to Measure PTSD-Related Functional Impairment in Children and Adolescents - A Validation Study in Switzerland and Germany
This project will test the PTSD-iMPACT questionnaire to measure PTSD-related day-to-day problems in children and adolescents who have experienced trauma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 7 Years to 18 Years |
| Sex | All |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 11 sites (Aachen and 10 other locations) |
| Trial ID | NCT07368166 on ClinicalTrials.gov |
What this trial studies
The study is a multi-center observational validation of the PTSD-iMPACT conducted in Switzerland and Germany. Development followed two phases: a systematic review that identified gaps in existing instruments, and qualitative interviews and focus groups with trauma-exposed children, adolescents, and caregivers to generate items and domains. The validation will recruit clinical participants (children/adolescents 7–18 and caregivers of children 3–18) and school-based non-clinical samples in Switzerland, using German-language measures and informed consent procedures. Psychometric analyses will examine domain structure, scoring, reliability, and validity across settings.
Who should consider this trial
Good fit: Ideal participants are German-speaking children and adolescents aged 7–18 with trauma exposure and at least moderate PTSS (and caregivers of children aged 3–18 for proxy reports), recruited from participating clinical centers or school samples in Switzerland.
Not a fit: Children outside the specified age ranges, those without sufficient German language skills, individuals not seen at participating sites, or those without required consent are unlikely to benefit directly from this validation.
Why it matters
Potential benefit: If successful, clinicians and researchers will have a validated questionnaire to pinpoint PTSD-related functional problems in young people and better target support and treatment.
How similar studies have performed: While psychometric approaches and adult PTSD functional measures have been successful, a PTSD-specific, validated functional instrument for youth is largely novel with limited prior validation work.
Eligibility criteria
Show full inclusion / exclusion criteria
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) Exclusion Criteria: * 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
Where this trial is running
Aachen and 10 other locations
- Traumaambulanz, Universitätsklinikum Aachen — Aachen, Germany (Not_yet_recruiting)
- Otto-Friedrich-Universität Bamberg — Bamberg, Germany (Not_yet_recruiting)
- Lehrstuhl für Klinische Psychologie und Kinder- und Jugendlichenpsychotherapie, Katholische Universität Eichstätt-Ingolstadt — Eichstätt, Germany (Not_yet_recruiting)
- Zentrum für Psychotherapie Bodensee (apb) — Konstanz, Germany (Not_yet_recruiting)
- Kinder- und Jugendlichen-Psychotherapie-Ambulanz (KJ-PAM) Marburg — Marburg, Germany (Not_yet_recruiting)
- Universitätsklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie Carl von Ossietzky Universität Oldenburg — Oldenburg, Germany (Not_yet_recruiting)
- Child and Adolescent Psychiatry Ulm University — Ulm, Germany (Not_yet_recruiting)
- Child and Adolescent Psychiatric Services Thurgau — Frauenfeld, Switzerland (Recruiting)
- • Parent-Child Consultation 0-5 of The Child and Adolescent Psychiatric Services St. Gallen — Sankt Gallen, Switzerland (Recruiting)
- Cantonal Hospital Winterthur — Winterthur, Switzerland (Recruiting)
- University Children's Hospital Zurich — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Lasse Bartels, Dr.
- Email: lasse.bartels@kispi.uzh.ch
- Phone: +41 44 249 56 60
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.