Post-traumatic Stress Disorder (PTSD)NCT06975852
Follow-Up Study on Children Exposed to Trauma
An observational study of Post-traumatic Stress Disorder (PTSD) and Complex Post-Traumatic Stress Disorder (CPTSD), run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
As far as it is known, there is no longitudinal study in Turkey investigating the follow-up and treatment of children and adolescents exposed to trauma. This study is planned to reassess children and adolescents with trauma exposure who were evaluated in Istanbul Faculty of Medicine Child Psychiatry outpatient clinic… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Post-traumatic Stress Disorder (PTSD), Complex Post-Traumatic Stress Disorder (CPTSD)
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2025to 15 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients applying to the Child and Adolescent Psychiatry outpatient clinic of Istanbul Faculty of Medicine
Who may be able to join
- Children-adolescents who were exposed to at least one traumatic event and who were evaluated within the scope of the thesis study one year ago (January-April 2024),
- Children and adolescents aged 7-18,
- Children and/or parents with adequate literacy and Turkish language skills.
Who cannot join
- The presence of psychotic/manic symptoms in the child or parent during the interview or any condition that makes the interview and assessment impossible (e.g., mental or developmental condition or a different communication language),
- The child or parent refusing to participate in the study,
- The presence of autism spectrum disorder or intellectual disability at a severity that prevents assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Faculty of Medicine
Istanbul, Fatih, 34116
Beyza N Karal, MD, +9002124142000, beyzakaral@istanbul.edu.tr
About this study
Official title: Trauma-Exposed Children and Adolescents: A One-Year Follow-Up Study
As far as it is known, there is no longitudinal study in Turkey investigating the follow-up and treatment of children and adolescents exposed to trauma. This study is planned to reassess children and adolescents with trauma exposure who were evaluated in Istanbul Faculty of Medicine Child Psychiatry outpatient clinic as part of a thesis study one year ago (January-April 2024) and to examine how many of them continue to meet the criteria for Post-Traumatic Stress Disorder (PTSD), how many receive a diagnosis of Complex Post-Traumatic Stress Disorder (CPTSD), and which factors are associated with these outcomes. In this way, it is aimed to contribute to the literature on the long-term effects of trauma exposure. Additionally, since there is no scale in our country that assesses the diagnosis of CPTSD in children, the study also aims to translate the Child and Adolescent Trauma Screen Scale - 2 (CATS-2) into Turkish and examine its psychometric properties.
Read the detailed description
This study will be conducted under the coordination of Istanbul Faculty of Medicine, Department of Child and Adolescent Psychiatry. Children and adolescents between the ages of 7-18 who have been exposed to trauma and who applied to the Child and Adolescent Psychiatry outpatient clinic of Istanbul Faculty of Medicine and who were evaluated within the scope of the thesis study one year ago (January-April 2024) will be re-evaluated one year later. It is aimed to reach all 210 children and adolescents and evaluate those who agree to participate in the study.
Sample:
- Children-adolescents who were exposed to at least one traumatic event and who were evaluated within the scope of the thesis study one year ago (January-April 2024),
- Children and adolescents aged 7-18,
- Children and/or parents with adequate literacy and Turkish language skills,
- Those without psychotic/manic symptoms or a diagnosis of autism spectrum disorder or intellectual disability in the child or parent during the interview,
- Volunteers who agree to participate in the study.
Researchers will explain the study to volunteer children and their families and present the Informed Consent Form to determine their willingness to participate.
Parents of eligible volunteers will complete the following assessments:
- Sociodemographic Data Form
- Hospital Anxiety and Depression Scale
- Advers Childhood Events Scale
- Positive Childhood Experiences Scale
- Strengths and Difficulties Questionnaire (Parent Form)
- Child and Adolescent Trauma Screen 2 - Caregiver Report
Volunteer children and adolescents will complete:
- Child and Adolescent Trauma Screen 2 - Self Report
- Revised Children's Anxiety and Depression Scale
- Positive Childhood Experiences Scale
- (Adolescent/Child's Self Report) Responses to Stress Questionnaire (Peer Stress)
The clinician will conduct the following assessments:
- ICD-11-based clinical interview
- UCLA PTSD Reaction Index for DSM-5
- Children's Global Assessment Scale (CGAS)
The start date for the study is February 17, 2025, and data analysis will commence afterward. Data will be analyzed using the Statistical Program for Social Sciences (SPSS for Windows, version 21.0). The study is expected to be completed by July 2025.
The coordinating center responsible for the research is the Department of Child and Adolescent Psychiatry at Istanbul Faculty of Medicine.
- Medical subject headings
- Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of PTSD and Complex PTSD in Children and Adolescents Exposed to Trauma
This study aims to investigate the prevalence of PTSD and CPTSD diagnoses one year after the initial assessment of trauma-exposed children and adolescents evaluated in our outpatient clinic between January and April 2024 as part of a thesis study.
Measured: Baseline
Factors Associated with the Diagnosis of PTSD and Complex PTSD
We aim to investigate the correlations between PTSD, CPTSD diagnoses and various clinical measures, such as the child's PTSD symptom severity assessed by the UCLA RI-5, the child's PACE score, the parent's ACE and PACE scores, and the severity of parental anxiety and depression.
Measured: Baseline
Adaptation of the Child and Adolescent Trauma Screen - 2 into Turkish, Evaluation of Its Psychometric Properties
Given the absence of an existing instrument to assess CPTSD in children in Turkey, this study also aims to translate the Child and Adolescent Trauma Screen - 2 (CATS-2) into Turkish and to evaluate its psychometric properties. The results of both the self-report and caregiver-report versions of the Turkish CATS-2, completed by children/adolescents and their parents respectively, will be compared with PTSD and CPTSD diagnoses obtained through a clinician-administered ICD-11-based clinical interview, as well as with the results of the UCLA PTSD Reaction Index for DSM-5 (RI-5).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start17 Feb 2025
- Primary completion18 Jul 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Family based
- Time perspective
- Other
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Nur Karal, Istanbul University
- Investigators
- Abdurrahman C Orengul, Associate Professor, Principal investigator, Istanbul Faculty of Medicine, Child and Adolescent Psychiatry Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975852
- Sponsor's protocol ID
- 2025/156
- Status last verified
- May 2025
- First submitted
- 25 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kucukardali RS, Karal BN, Ozkal A, Erus SM, Gormez V, Orengul AC. Validation of the Child and Adolescent Trauma Screen-2 (CATS-2) in a Turkish clinical sample: psychometric properties across ICD-11 and DSM-5 frameworks. Eur J Psychotraumatol. 2026 Dec;17(1):2694190. doi: 10.1080/20008066.2026.2694190. Epub 2026 Jul 28.
PubMed 42517355
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma-Exposed Children and Adolescents: A One-Year Follow-Up Study
- ClinicalTrials.gov ID
- NCT06975852
- Acronym / sponsor ID
- 2025/156
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 18 Jul 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 16 May 2025 (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.
As far as it is known, there is no longitudinal study in Turkey investigating the follow-up and treatment of children and adolescents exposed to trauma. This study is planned to reassess children and adolescents with trauma exposure who were evaluated in Istanbul Faculty of Medicine Child Psychiatry outpatient clinic as part of a thesis study one year ago (January-April 2024) and to examine how many of them continue to meet the criteria for Post-Traumatic Stress Disorder (PTSD), how many receive a diagnosis of Complex Post-Traumatic Stress Disorder (CPTSD), and which factors are associated with these outcomes. In this way, it is aimed to contribute to the literature on the long-term effects of trauma exposure. Additionally, since there is no scale in our country that assesses the diagnosis of CPTSD in children, the study also aims to translate the Child and Adolescent Trauma Screen Scale - 2 (CATS-2) into Turkish and examine its psychometric properties.
Detailed description
This study will be conducted under the coordination of Istanbul Faculty of Medicine, Department of Child and Adolescent Psychiatry. Children and adolescents between the ages of 7-18 who have been exposed to trauma and who applied to the Child and Adolescent Psychiatry outpatient clinic of Istanbul Faculty of Medicine and who were evaluated within the scope of the thesis study one year ago (January-April 2024) will be re-evaluated one year later. It is aimed to reach all 210 children and adolescents and evaluate those who agree to participate in the study.
Sample:
- Children-adolescents who were exposed to at least one traumatic event and who were evaluated within the scope of the thesis study one year ago (January-April 2024),
- Children and adolescents aged 7-18,
- Children and/or parents with adequate literacy and Turkish language skills,
- Those without psychotic/manic symptoms or a diagnosis of autism spectrum disorder or intellectual disability in the child or parent during the interview,
- Volunteers who agree to participate in the study.
Researchers will explain the study to volunteer children and their families and present the Informed Consent Form to determine their willingness to participate.
Parents of eligible volunteers will complete the following assessments:
- Sociodemographic Data Form
- Hospital Anxiety and Depression Scale
- Advers Childhood Events Scale
- Positive Childhood Experiences Scale
- Strengths and Difficulties Questionnaire (Parent Form)
- Child and Adolescent Trauma Screen 2 - Caregiver Report
Volunteer children and adolescents will complete:
- Child and Adolescent Trauma Screen 2 - Self Report
- Revised Children's Anxiety and Depression Scale
- Positive Childhood Experiences Scale
- (Adolescent/Child's Self Report) Responses to Stress Questionnaire (Peer Stress)
The clinician will conduct the following assessments:
- ICD-11-based clinical interview
- UCLA PTSD Reaction Index for DSM-5
- Children's Global Assessment Scale (CGAS)
The start date for the study is February 17, 2025, and data analysis will commence afterward. Data will be analyzed using the Statistical Program for Social Sciences (SPSS for Windows, version 21.0). The study is expected to be completed by July 2025.
The coordinating center responsible for the research is the Department of Child and Adolescent Psychiatry at Istanbul Faculty of Medicine.
Study design
- Observational model
- Family based
- Time perspective
- Other
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients applying to the Child and Adolescent Psychiatry outpatient clinic of Istanbul Faculty of Medicine
Key inclusion criteria (3 listed)
- Children-adolescents who were exposed to at least one traumatic event and who were evaluated within the scope of the thesis study one year ago (January-April 2024),
- Children and adolescents aged 7-18,
- Children and/or parents with adequate literacy and Turkish language skills.
Key exclusion criteria (3 listed)
- The presence of psychotic/manic symptoms in the child or parent during the interview or any condition that makes the interview and assessment impossible (e.g., mental or developmental condition or a different communication language),
- The child or parent refusing to participate in the study,
- The presence of autism spectrum disorder or intellectual disability at a severity that prevents assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of PTSD and Complex PTSD in Children and Adolescents Exposed to Trauma
Time frame: Baseline
This study aims to investigate the prevalence of PTSD and CPTSD diagnoses one year after the initial assessment of trauma-exposed children and adolescents evaluated in our outpatient clinic between January and April 2024 as part of a thesis study.
Factors Associated with the Diagnosis of PTSD and Complex PTSD
Time frame: Baseline
We aim to investigate the correlations between PTSD, CPTSD diagnoses and various clinical measures, such as the child's PTSD symptom severity assessed by the UCLA RI-5, the child's PACE score, the parent's ACE and PACE scores, and the severity of parental anxiety and depression.
Adaptation of the Child and Adolescent Trauma Screen - 2 into Turkish, Evaluation of Its Psychometric Properties
Time frame: Baseline
Given the absence of an existing instrument to assess CPTSD in children in Turkey, this study also aims to translate the Child and Adolescent Trauma Screen - 2 (CATS-2) into Turkish and to evaluate its psychometric properties. The results of both the self-report and caregiver-report versions of the Turkish CATS-2, completed by children/adolescents and their parents respectively, will be compared with PTSD and CPTSD diagnoses obtained through a clinician-administered ICD-11-based clinical interview, as well as with the results of the UCLA PTSD Reaction Index for DSM-5 (RI-5).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 42517355Kucukardali RS, Karal BN, Ozkal A, Erus SM, Gormez V, Orengul AC. Validation of the Child and Adolescent Trauma Screen-2 (CATS-2) in a Turkish clinical sample: psychometric properties across ICD-11 and DSM-5 frameworks. Eur J Psychotraumatol. 2026 Dec;17(1):2694190. doi: 10.1080/20008066.2026.2694190. Epub 2026 Jul 28.
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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.
Abdurrahman C Orengul, Associate Professor principal investigator
Istanbul Faculty of Medicine, Child and Adolescent Psychiatry Department
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 Post-traumatic Stress Disorder (PTSD) and Complex Post-Traumatic Stress Disorder (CPTSD), run by Istanbul University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 May 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beyza N Karal, MD (+9002124142000, beyzakaral@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of PTSD and Complex PTSD in Children and Adolescents Exposed to Trauma (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06975852, which also lists 1 linked publication.
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 16 May 2025.