PTSDNCT05984706
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
An observational study of PTSD and Functioning, Psychosocial, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- PTSD, Functioning, Psychosocial
- What is being tested?
- Focus groups and Delphi Questionnaire
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Nov 2023to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1. Children and adolescents (7-18years old) who experienced at least one traumatic event. 2. Caregivers of children and adolescents (1-18 years old) who experienced at least one traumatic event. 3. Clinical experts
Who may be able to join
- 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.
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- 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 recruitment or they present with at least a moderate PTSS severity according to the Child and Adolescents Trauma Screen 2 (CATS-2).
- Caregivers must have sufficient command of the German language.
- 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 clinical experts:
- Clinician or researcher specialized in trauma and PTSD in children and adolescents.
- Clinical experts must have sufficient command of the English language.
Who cannot join
- For children and adolescent participants:
- Children and Adolescents who have not experienced at least one PTE according to the DSM-5 definition of a traumatic event.
- The PTE(s) occurred before the fourth birthday.
- The PTE(s) occurred less than 1 month ago.
- Children and adolescents that are younger than 7 years old and older than 18 years old.
- Children and adolescents that are neither in trauma-focused therapy at the time of recruitment nor meet the CATS-2 score for moderate PTSS severity or higher.
Show all 21Show fewer
- Children and adolescents that do not have sufficient command of the German language.
- Children and adolescents that have physical impairment due to injuries or somatic illnesses (self-assessment).
- Children and adolescents that are acute suicidal. The responsible psychotherapists or supervisors of the "Schlupfhuus" will provide information about it.
- For caregivers:
- Caregivers of children or adolescents who have not experienced at least one PTE according to the DSM-5 definition of a traumatic event.
- The PTE(s) occurred less than 1 month ago.
- The child or adolescent is younger than 1 year old or older than 18 years old.
- The child or adolescent is neither in trauma-focused therapy at the time of recruitment nor meets the CATS-2 score for moderate PTSS severity or higher.
- Caregivers that do not have sufficient command of the German language.
- Children and adolescents that have physical impairment due to injuries or somatic illnesses (self-assessment).
- Children and adolescents that are acute suicidal. The responsible psychotherapists or supervisors of the "Schlupfhuus" will provide information about it.
- For clinical experts:
- Clinical experts that don't work as clinician or as researcher specialized in trauma and PTSD in children and adolescents.
- Clinical experts that do not have sufficient command of the English language.
- All the participants' informed consent must be obtained before any data is collected.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University-Children's Hospital Zurich
Zurich, Canton of Zurich, 8832
About this study
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.
- Conditions
- PTSD, Functioning, Psychosocial
- Being tested
- Focus groups and Delphi Questionnaire
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groups and Delphi QuestionnaireOther
- Focus groups to identify relevant domains of PTSD-related functional impairment in trauma-exposed children and adolescents to ensure content validity. 2. Delphi Questionnaire evaluation of a list of domains of PTSD-related functional impairment in trauma-exposed children and adolescents (previously selected from based on a literature review and focus groups) on a Likert scale of 1 to 5 for their relevance
| Study group | Role | What they receive |
|---|---|---|
| Trauma-exposed children and adolescents | Focus group and Delphi survey Receives: Other: Focus groups and Delphi Questionnaire | |
| Caregivers of trauma-exposed children and adolescents | Focus group and Delphi survey Receives: Other: Focus groups and Delphi Questionnaire | |
| Clinical experts | Delphi survey Receives: Other: Focus groups and Delphi Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
A set of relevant domains and corresponding difficulties within domains of functional impairment in trauma-exposed children and adolescents, identified in focus groups.
Relevant domains of PTSD-related functional impairment in trauma-exposed children and adolescents will be identified via focus groups. Trauma-exposed children and adolescents and caregivers will participate in small focus groups.
Measured: Oct23-Nov23
A set of relevant domains and corresponding difficulties within domains of functional impairment in trauma-exposed children and adolescents, identified in a Delphi survey.
Based on the results of the focus group discussions, relevant domains of PTSD-related functional impairment in trauma-exposed children and adolescents will be identified via Delphi survey. Trauma-exposed children and adolescents, caregivers and clinical experts will participate. Due to the exploratory design, no pre-existig scale will be used. Participants will be asked to assess the previously identified areas of PTSD-related functional impairment in children and adolescents based on their importance. For each previously identified domain, a 5-point Likert scale will be used to indicate how important it is to include that domain in the questionnaire we are developing.The scale ranges from (1) not important to (5) very important. High scores indicate that it is important to include a specific domain in the questionnaire. If the importance of a domain is rated above 1, the importance of specific difficulties within that domain will then be assessed on the same 5-point Likert scale.
Measured: Nov23-Feb24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start20 Nov 2023
- Primary completion31 Jan 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lasse Bartels, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984706
- Sponsor's protocol ID
- 2023-01290
- Other IDs
- 2023
- Status last verified
- Dec 2024
- First submitted
- 21 Jul 2023
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05984706
- Acronym / sponsor ID
- 2023-01290
- Conditions
- PTSD, Functioning, Psychosocial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trauma-exposed children and adolescents | – | Other: Focus groups and Delphi QuestionnaireFocus group and Delphi survey |
| Caregivers of trauma-exposed children and adolescents | – | Other: Focus groups and Delphi QuestionnaireFocus group and Delphi survey |
| Clinical experts | – | Other: Focus groups and Delphi QuestionnaireDelphi survey |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Children and adolescents (7-18years old) who experienced at least one traumatic event. 2. Caregivers of children and adolescents (1-18 years old) who experienced at least one traumatic event. 3. Clinical experts
Key inclusion criteria (21 listed)
- The same inclusion criteria apply for the focus group discussions and for the Delphi process.
- 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.
Key exclusion criteria (21 listed)
- For children and adolescent participants:
- Caregivers of children or adolescents who have not experienced at least one PTE according to the DSM-5 definition of a traumatic event.
- The PTE(s) occurred less than 1 month ago.
- The child or adolescent is younger than 1 year old or older than 18 years old.
- The child or adolescent is neither in trauma-focused therapy at the time of recruitment nor meets the CATS-2 score for moderate PTSS severity or higher.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus groups and Delphi Questionnaire1. Focus groups to identify relevant domains of PTSD-related functional impairment in trauma-exposed children and adolescents to ensure content validity. 2. Delphi Questionnaire evaluation of a list of domains of PTSD-related functional impairment in trauma-exposed children and adolescents (previously selected from based on a literature review and focus groups) on a Likert scale of 1 to 5 for their relevance | Other | Caregivers of trauma-exposed children and adolescents, Clinical experts, Trauma-exposed children and adolescents |
Primary outcome
A set of relevant domains and corresponding difficulties within domains of functional impairment in trauma-exposed children and adolescents, identified in focus groups.
Time frame: Oct23-Nov23
Relevant domains of PTSD-related functional impairment in trauma-exposed children and adolescents will be identified via focus groups. Trauma-exposed children and adolescents and caregivers will participate in small focus groups.
A set of relevant domains and corresponding difficulties within domains of functional impairment in trauma-exposed children and adolescents, identified in a Delphi survey.
Time frame: Nov23-Feb24
Based on the results of the focus group discussions, relevant domains of PTSD-related functional impairment in trauma-exposed children and adolescents will be identified via Delphi survey. Trauma-exposed children and adolescents, caregivers and clinical experts will participate. Due to the exploratory design, no pre-existig scale will be used. Participants will be asked to assess the previously identified areas of PTSD-related functional impairment in children and adolescents based on their importance. For each previously identified domain, a 5-point Likert scale will be used to indicate how important it is to include that domain in the questionnaire we are developing.The scale ranges from (1) not important to (5) very important. High scores indicate that it is important to include a specific domain in the questionnaire. If the importance of a domain is rated above 1, the importance of specific difficulties within that domain will then be assessed on the same 5-point Likert scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD and Functioning, Psychosocial, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A set of relevant domains and corresponding difficulties within domains of functional impairment in trauma-exposed children and adolescents, identified in focus groups. (time frame: Oct23-Nov23). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.