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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-18
SponsorUniversity Children's Hospital, Zurich

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Students between 3rd grade and 18 years / caregivers of kindergarteners and students up until 18 years

Trial 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.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

1,200 Participants
are grouped into 2 trial groups
Group A: Clinical population
Group B: Non-clinical population

Trial outcomes

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)

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

Secondary outcomes

1

Potentially traumatic events (PTE) (Children and adolescents aged 7 to 18 years)

Child and Adolescent Trauma Screen (CATS 2)

Time frame
Baseline and Follow-up two weeks later. In nonclinical samples, data will be only assessed at Baseline.
2

PTSD (Children and adolescents aged 7 to 18 years)

Child and Adolescent Trauma Screen (CATS 2)

Time frame
Baseline and Follow-up two weeks later. In nonclinical samples, data will be only assessed at Baseline.
3

Depression (Children and adolescents aged 7 to 18 years)

International Depression Questionnaire (IDQ)

Time frame
Baseline
4

Anxiety (Children and adolescents aged 7 to 18 years)

International Anxiety Questionnaire (IAQ

Time frame
Baseline

Other outcomes

1

Sociodemographic information of Children and adolescents

Age (in years), gender/sex, type of school, school grade, number of siblings, country of origin of child, country of origin of caregiver, employment of caregiver, living situation, satisfaction with academic performance, psychotherapy

Time frame
Baseline
2

Sociodemographic information of caregivers

Age (in years) of child and caregiver, gender/sex child and caregiver, type of school child, school grade child, number of siblings child, country of origin of caregiver, education of caregiver, employment of caregiver, child's living situation, child's satisfaction with academic performance, psychotherapy child

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Children's Hospital, Zurich

Lead sponsor

University Clinic for Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany

Collaborator

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