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

NCT07368166 | Recruiting

• 1 other identifier: BASEC 2025-01470
• Study Type: observational
• Target: 1,200
• Locations: 2 countries
• Sites: 11

Brief 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.

Conditions

PTSD-Related Functional Impairment in Children and Adolescents; PTSD - Post Traumatic Stress Disorder

Keywords

PTSD; PTSS; Functional Impairment; PTSD-iMPACT; Validation; Posttraumatic stress disorder; Posttraumatic stress symptoms

Outcome Measures

Primary Outcomes (1)

• PTSD-iMPACT (newly developed questionnaire)

  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)

  Baseline and Follow-up two weeks later. In nonclinical samples, data will be only assessed at Baseline.

Secondary Outcomes (15)

• 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

Other Outcomes (2)

• Sociodemographic information of Children and adolescents

  Baseline

• Sociodemographic information of caregivers

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Clinical sample: As far as possible, every patient and/or caregiver who visits the participating clinical institutions or medical settings in Switzerland and Germany for the first time (inpatient or outpatient) will be invited to participate in the study. Non-clinical sample: Data of students (all German-speaking cantons) and caregivers of kindergartners (all German-speaking cantons) and students (all German-speaking cantons) will be collected.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Clinic for Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany: collaborator
• University Children's Hospital, Zurich: lead
• Outpatient clinic for trauma, Clinic for Psychiatry, Psychosomatics, and Psychotherapy for Children and Adolescents, RHTW Aachen, Aachen, Deutschland: collaborator
• Psychotherapeutic outpatient clinic for children and adolescents, Catholic University Eichstätt-Ingolstadt, Germany: collaborator
• Psychotherapeutic outpatient clinic for children and adolescents, University of Bamberg, Bamberg, Germany: collaborator
• Center for Psychotherapie Bodensee (apb), Konstanz, Deutschland: collaborator
• Child and Adolescent Outpatient Clinic (KJ-PAM), Universität Marburg, Marburg, Deutschland: collaborator
• Child and Adolescent Psychiatric Services Thurgau, Switzerland: collaborator
• Child and Adolescent Psychiatric Services St. Gallen, Switzerland: collaborator
• Cantonal Hospital Winterthur, Switzerland: collaborator

Study Sites (11)

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, 8008, Switzerland

RECRUITING

Related Publications (17)

• Hyland P, Karatzias T, Shevlin M, McElroy E, Ben-Ezra M, Cloitre M, Brewin CR. Does requiring trauma exposure affect rates of ICD-11 PTSD and complex PTSD? Implications for DSM-5. Psychol Trauma. 2021 Feb;13(2):133-141. doi: 10.1037/tra0000908. Epub 2020 Sep 10.

  PMID: 32915045 BACKGROUND

• Cloitre M, Shevlin M, Brewin CR, Bisson JI, Roberts NP, Maercker A, Karatzias T, Hyland P. The International Trauma Questionnaire: development of a self-report measure of ICD-11 PTSD and complex PTSD. Acta Psychiatr Scand. 2018 Dec;138(6):536-546. doi: 10.1111/acps.12956. Epub 2018 Sep 3.

  PMID: 30178492 BACKGROUND

• Haag AC, Cha CB, Noll JG, Gee DG, Shenk CE, Schreier HMC, Heim CM, Shalev I, Rose EJ, Jorgensen A, Bonanno GA. The Flexible Regulation of Emotional Expression Scale for Youth (FREE-Y): Adaptation and Validation Across a Varied Sample of Children and Adolescents. Assessment. 2023 Jun;30(4):1265-1284. doi: 10.1177/10731911221090465. Epub 2022 May 5.

  PMID: 35510578 BACKGROUND

• Vasileva, M., Marsac, M. L., Alisic, E., Cobham, V. E., Davis, S. H., Donovan, C., ... & De Young, A. (2022). Preschooler stressor-related thoughts and worries during the COVID-19 pandemic: Development and validation of a caregiver-report instrument. Traumatology.

  BACKGROUND

• Vogt, A., Berliner, L., Sachser, C., Theimer, K., Landolt, M. A., & Bartels, L. (2025). PTSD-iMPairment in Adolescent & Children's capacity for Thriving (PTSD-iMPACT). [Unpublished measurement instrument]. University Children's Hospital Zurich.

  BACKGROUND

• Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.

  PMID: 11468499 BACKGROUND

• Kristensen S, Henriksen TB, Bilenberg N. The Child Behavior Checklist for Ages 1.5-5 (CBCL/1(1/2)-5): assessment and analysis of parent- and caregiver-reported problems in a population-based sample of Danish preschool children. Nord J Psychiatry. 2010 May 4;64(3):203-9. doi: 10.3109/08039480903456595.

  PMID: 20085433 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Jassi A, Lenhard F, Krebs G, Gumpert M, Jolstedt M, Andren P, Nord M, Aspvall K, Wahlund T, Volz C, Mataix-Cols D. The Work and Social Adjustment Scale, Youth and Parent Versions: Psychometric Evaluation of a Brief Measure of Functional Impairment in Young People. Child Psychiatry Hum Dev. 2020 Jun;51(3):453-460. doi: 10.1007/s10578-020-00956-z.

  PMID: 32006302 BACKGROUND

• Ravens-Sieberer U, Herdman M, Devine J, Otto C, Bullinger M, Rose M, Klasen F. The European KIDSCREEN approach to measure quality of life and well-being in children: development, current application, and future advances. Qual Life Res. 2014 Apr;23(3):791-803. doi: 10.1007/s11136-013-0428-3. Epub 2013 May 18.

  PMID: 23686556 BACKGROUND

• Redican E, Sachser C, Berliner L, Pfeiffer E, Martsenkovskyi D, Hyland P, Ben-Ezra M, Shevlin M. Development and validation of the caregiver-report version of the international depression questionnaire (IDQ-CG) and international anxiety questionnaire (IAQ-CG). Eur Child Adolesc Psychiatry. 2025 Jan;34(1):297-305. doi: 10.1007/s00787-024-02495-7. Epub 2024 Jun 18.

  PMID: 38888671 BACKGROUND

• Bartels, L., Berliner, L., Landolt, M., Shevlin, M., & Sachser, C. (2025). International Adjustment Disorder Questionnaire - Child and Adolescent Version (IADQ-CA) [Unpublished questionnaire]. University Children's Hospital Zurich.

  BACKGROUND

• Sachser C, Berliner L, Holt T, Jensen TK, Jungbluth N, Risch E, Rosner R, Goldbeck L. International development and psychometric properties of the Child and Adolescent Trauma Screen (CATS). J Affect Disord. 2017 Mar 1;210:189-195. doi: 10.1016/j.jad.2016.12.040. Epub 2016 Dec 27.

  PMID: 28049104 BACKGROUND

• Nilsson D, Davelid I, Ledin S, Svedin CG. Psychometric properties of the Child and Adolescent Trauma Screen (CATS) in a sample of Swedish children. Nord J Psychiatry. 2021 May;75(4):247-256. doi: 10.1080/08039488.2020.1840628. Epub 2020 Nov 8.

  PMID: 33164607 BACKGROUND

• Sachser C, Berliner L, Risch E, Rosner R, Birkeland MS, Eilers R, Hafstad GS, Pfeiffer E, Plener PL, Jensen TK. The child and Adolescent Trauma Screen 2 (CATS-2) - validation of an instrument to measure DSM-5 and ICD-11 PTSD and complex PTSD in children and adolescents. Eur J Psychotraumatol. 2022 Aug 1;13(2):2105580. doi: 10.1080/20008066.2022.2105580. eCollection 2022.

  PMID: 35928521 BACKGROUND

• Vogt, A. J., Landolt, M. A., Skjærvø, I., Hermann, R. M.m Pfeiffer, E., Sachser, C., & Bartels, L. (in preparation) Assessment of Posttraumatic Stress-Related Functional Impairment in Children and Adolescents: a Systematic Review.

  BACKGROUND

• Landolt MA, Schnyder U, Maier T, Schoenbucher V, Mohler-Kuo M. Trauma exposure and posttraumatic stress disorder in adolescents: a national survey in Switzerland. J Trauma Stress. 2013 Apr;26(2):209-16. doi: 10.1002/jts.21794. Epub 2013 Mar 13.

  PMID: 23494743 BACKGROUND

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Lasse Bartels, Dr.

CONTACT

+41 44 249 56 60; lasse.bartels@kispi.uzh.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 26, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 26, 2026

Record last verified: 2025-12

Locations

DE (7); CH (4)