- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07697534
Two-Year Follow-up Study on Children Exposed to Trauma (Complex PTSD)
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Fatih
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Istanbul, Fatih, Turkey (Türkiye), 34116
- İstanbul Esnaf Hastanesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prevalence of PTSD and Complex PTSD in Children and Adolescents Exposed to Trauma
Time Frame: from january 2024 to august 2026
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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.
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from january 2024 to august 2026
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Factors Associated with the Diagnosis of PTSD and Complex PTSD
Time Frame: from march 2026 to august 2026
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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
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from march 2026 to august 2026
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Kucukardali 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/470
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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