Post-traumatic Stress Disorder (PTSD)Complex PTSDNCT07697534
Two-Year 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
In our clinic, we plan to conduct research two years after the initial assessments (January-April 2024 and one year ago, January-June 2025) of children and adolescents with trauma exposure who were evaluated as part of their thesis studies. 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
- 136 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 15 Oct 2026
- How long will I take part?
- 2 Years
- 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 two year ago (January-April 2024), and one year ago (January-June 2025), 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.
Turkey (Türkiye)1 site
İstanbul Esnaf Hastanesi
Istanbul, Fatih, 34116
About this study
In our clinic, we plan to conduct research two years after the initial assessments (January-April 2024 and one year ago, January-June 2025) of children and adolescents with trauma exposure who were evaluated as part of their thesis studies. The aim is to re-evaluate these individuals to determine how many continue to receive a PTSD diagnosis, how many receive a diagnosis of K-PTSD, and what factors are associated with these changes. This research aims to contribute to the literature on the long-term effects of trauma exposure.
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 two year ago (January-April 2024) and one year ago (January-June 2025), will be re-evaluated two year later. It is aimed to reach all 136 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 two year ago (January-April 2024) and re-evaluated by a doctor a year ago; 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
- Brief Psychological Resilience Scale
- Pittsburgh Sleep Quality Index
- Mood Disorders and Schizophrenia Interview Schedule for School-Aged Children (MAS-S)
- International Trauma Scale - Child and Adolescent Version
- Children's Anxiety and Depression Scale - Revised
- UCLA Post-Traumatic Stress Disorder Reaction Index for DSM-5
- Children's General Assessment Scale
- ICD-11-based clinical interview
The start date for the study is March 2026, 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 October 2026
The coordinating center responsible for the research is the Department of Child and Adolescent Psychiatry at Istanbul Faculty of Medicine.
- Keywords
- ptsd, complex ptsd, cptsd, trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| children who had at least one trauma two years ago | Inclusion Criteria: Children-adolescents who were exposed to at least one traumatic event and who were evaluated within the scope of the thesis study two year ago (January-April 2024), and one year ago (January-June 2025), Children and adolescents aged 7-18, Children and/or parents with adequate literacy and Turkish language skills. Exclusion Criteria: 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. |
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, as part of thesis research, aims to investigate the prevalence of PTSD and CPTSD diagnoses two years after the initial evaluation in trauma-exposed children and adolescents evaluated in our outpatient clinic between January-April 2024 and January-June 2025.
Measured: from january 2024 to august 2026
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, psychological resilience, sleep routines, and anxiety/depression severity
Measured: from march 2026 to august 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start15 Mar 2026
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afife Özkal, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697534
- Sponsor's protocol ID
- 2026/470
- Acronym
- Complex PTSD
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in order to protect the privacy and confidentiality of the pediatric participants and their families, in accordance with the ethical approval granted for this study.
Publications
Orengul AC, Kucukardali RS, Karal BN, Gormez V. Psychometric Assessment of the UCLA PTSD Reaction Index for DSM-5 Brief Form in a Clinical Sample of Turkish Youth. Child Psychiatry Hum Dev. 2025 Aug 13. doi: 10.1007/s10578-025-01905-4. Online ahead of print.
PubMed 40802207Kucukardali RS, Karal BN, Steinberg AM, Orengul AC. Psychometric evaluation of the UCLA PTSD Reaction Index (PTSD RI-5) in a Turkish Clinical sample of trauma-exposed children. Eur J Psychotraumatol. 2025 Dec;16(1):2465082. doi: 10.1080/20008066.2025.2465082. Epub 2025 Feb 24.
PubMed 39989342
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Year Follow-up Study on Children Exposed to Trauma
- ClinicalTrials.gov ID
- NCT07697534
- Acronym / sponsor ID
- Complex PTSD / 2026/470
- Keywords
- ptsd, complex ptsd, cptsd, trauma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 13 Jul 2026 (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.
In our clinic, we plan to conduct research two years after the initial assessments (January-April 2024 and one year ago, January-June 2025) of children and adolescents with trauma exposure who were evaluated as part of their thesis studies. The aim is to re-evaluate these individuals to determine how many continue to receive a PTSD diagnosis, how many receive a diagnosis of K-PTSD, and what factors are associated with these changes. This research aims to contribute to the literature on the long-term effects of trauma exposure.
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 two year ago (January-April 2024) and one year ago (January-June 2025), will be re-evaluated two year later. It is aimed to reach all 136 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 two year ago (January-April 2024) and re-evaluated by a doctor a year ago; 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
- Brief Psychological Resilience Scale
- Pittsburgh Sleep Quality Index
- Mood Disorders and Schizophrenia Interview Schedule for School-Aged Children (MAS-S)
- International Trauma Scale - Child and Adolescent Version
- Children's Anxiety and Depression Scale - Revised
- UCLA Post-Traumatic Stress Disorder Reaction Index for DSM-5
- Children's General Assessment Scale
- ICD-11-based clinical interview
The start date for the study is March 2026, 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 October 2026
The coordinating center responsible for the research is the Department of Child and Adolescent Psychiatry at Istanbul Faculty of Medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children who had at least one trauma two years ago | – | –Inclusion Criteria: Children-adolescents who were exposed to at least one traumatic event and who were evaluated within the scope of the thesis study two year ago (January-April 2024), and one year ago (January-June 2025), Children and adolescents aged 7-18, Children and/or parents with adequate literacy and Turkish language skills. Exclusion Criteria: 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. |
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 (1 listed)
- Children-adolescents who were exposed to at least one traumatic event and who were evaluated within the scope of the thesis study two year ago (January-April 2024), and one year ago (January-June 2025), Children and adolescents aged 7-18, Children and/or parents with adequate literacy and Turkish language skills.
Key exclusion criteria (1 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: from january 2024 to august 2026
This study, as part of thesis research, aims to investigate the prevalence of PTSD and CPTSD diagnoses two years after the initial evaluation in trauma-exposed children and adolescents evaluated in our outpatient clinic between January-April 2024 and January-June 2025.
Factors Associated with the Diagnosis of PTSD and Complex PTSD
Time frame: from march 2026 to august 2026
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, psychological resilience, sleep routines, and anxiety/depression severity
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 13 Jul 2026.
- Results publication: PubMed 40802207Orengul AC, Kucukardali RS, Karal BN, Gormez V. Psychometric Assessment of the UCLA PTSD Reaction Index for DSM-5 Brief Form in a Clinical Sample of Turkish Youth. Child Psychiatry Hum Dev. 2025 Aug 13. doi: 10.1007/s10578-025-01905-4. Online ahead of print.
- Results publication: PubMed 39989342Kucukardali RS, Karal BN, Steinberg AM, Orengul AC. Psychometric evaluation of the UCLA PTSD Reaction Index (PTSD RI-5) in a Turkish Clinical sample of trauma-exposed children. Eur J Psychotraumatol. 2025 Dec;16(1):2465082. doi: 10.1080/20008066.2025.2465082. Epub 2025 Feb 24.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in order to protect the privacy and confidentiality of the pediatric participants and their families, in accordance with the ethical approval granted for this study.
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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 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. 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?
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?
Prevalence of PTSD and Complex PTSD in Children and Adolescents Exposed to Trauma (time frame: from january 2024 to august 2026). 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?
On the ClinicalTrials.gov record for NCT07697534, which also lists 2 linked publications.
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 13 Jul 2026.