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

March 6, 2025 updated by: Lasse Bartels, University Children's Hospital, Zurich
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8832
        • University-Children's Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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 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.

Exclusion Criteria:

  • 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.
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Trauma-exposed children and adolescents
Focus group and Delphi survey
Other: Focus groups and Delphi Questionnaire
1. 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
Caregivers of trauma-exposed children and adolescents
Focus group and Delphi survey
Other: Focus groups and Delphi Questionnaire
1. 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
Clinical experts
Delphi survey
Other: Focus groups and Delphi Questionnaire
1. 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
Nov23-Feb24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Children's Hospital, Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-01290

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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