What Difficulties Do Children and Adolescents Experience in Everyday Activities After a Traumatic… (NCT05984706) | Clinical Trial Compass
CompletedNot Applicable
What Difficulties Do Children and Adolescents Experience in Everyday Activities After a Traumatic Event? Focus Groups and Delphi Survey for the Development of a Questionnaire on PTSD-related Functional Impairment
Switzerland50 participantsStarted 2023-11-20
Plain-language summary
Post-traumatic Stress Disorder (PTSD) in children and adolescents is often associated with a myriad of significant impairments in daily functioning, including family relationships, school/work, leisure time activities, and social relationships. While a majority of attention has been placed on definition and assessment of post-traumatic stress symptoms (PTSS), less emphasis has been placed on the effect of PTSS on related functional impairment in daily life. The current assessment of PTSD-related functional impairment is conducted either with additional items inserted in PTSD measures that inquire about daily functioning or with the utilization of global functional impairment measures. The former approach is usually based on face validity only and varies content-wise. The latter approach often consists of scales that conflate symptoms with functioning, focus on impairment due to physical rather than mental health problems, and are not validated in trauma-exposed children and adolescents. Furthermore, scales usually do not include sufficient age-specific adjustments for younger children. Thus, the current assessment of PTSD-related functional impairment in children and adolescents demonstrates noteworthy shortcomings. Despite the well-recognized debilitating effect of PTSD on daily functioning, no measure has yet been developed to assess PTSD-related functional impairment tailored to trauma-exposed children and adolescents based on the input from the target population and their caregivers. The aim of this project is therefore to develop an instrument that assesses PTSD-related functional impairment in trauma-exposed children and adolescents (young children age 1-6 years (caregiver-report) as well as for older children and adolescents age 7-18 years (self- and caregiver-report)) by conducting focus groups and a Delphi survey.
Who can participate
Age range
7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
The same inclusion criteria apply for the focus group discussions and for the Delphi process.
For children and adolescents:
* Children and adolescents, who experienced at least one PTE according to the DSM-5 definition of a traumatic event.
* The PTE(s) must have occurred after the fourth birthday.
* The PTE(s) must have occurred at least 1 month ago.
* Children and adolescents must be 7-18 years of age.
* Children and adolescents are either in trauma-focused treatment at the time of recruitment or they present with at least a moderate PTSS severity according to the Child and Adolescents Trauma Screen 2 (CATS-2) Self-report.
* Children and adolescents must have sufficient command of the German language, excluding a small group of 4-5 unaccompanied refugee adolescents who will also be included. This group will be assisted by an interpreter.
* The children and adolescents do not have any physical impairment due to injuries or somatic illnesses (self-assessment).
* The children and adolescents are not acute suicidal. The responsible psychotherapists or supervisors of the "Schlupfhuus" will provide information about it.
For caregivers:
* Caregivers of children and adolescents, who experienced at least one PTE according to the DSM-5 definition of a traumatic event.
* The PTE(s) must have occurred at least 1 month ago.
* The child or adolescent must be between 1-18 years of age.
* Children and adolescents are either in trauma-focused therapy at the time of …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
A set of relevant domains and corresponding difficulties within domains of functional impairment in trauma-exposed children and adolescents, identified in focus groups.
Timeframe: Oct23-Nov23
2
A set of relevant domains and corresponding difficulties within domains of functional impairment in trauma-exposed children and adolescents, identified in a Delphi survey.