Complex Post-Traumatic Stress Disorder (CPTSD)NCT06918899
Prevalence of Complex PTSD in Trauma-Exposed Children-Adolescents and Related Factors
An observational study of Complex Post-Traumatic Stress Disorder (CPTSD) and Post-traumatic Stress Disorder (PTSD), run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to assess the psychiatric evaluation of children and adolescents exposed to trauma in the outpatient clinic and to determine the prevalence of PTSD and Complex PTSD (CPTSD) diagnoses. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Complex Post-Traumatic Stress Disorder (CPTSD), Post-traumatic Stress Disorder (PTSD)
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2025to Jul 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 Mental Health and Disorders Outpatient Clinic of Istanbul Faculty of Medicine
Who may be able to join
- Having been exposed to at least one traumatic event,
- Being between the ages of 7 and 18,
- The child and/or their parents (or caregivers) having adequate literacy and Turkish communication 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: Identifying the Prevalence of Complex Post-Traumatic Stress Disorder in Trauma-Exposed Children and Adolescents and Examining Related Factors
The aim of this study is to assess the psychiatric evaluation of children and adolescents exposed to trauma in the outpatient clinic and to determine the prevalence of PTSD and Complex PTSD (CPTSD) diagnoses. Additionally, it aims to compare the clinical characteristics of children exposed to trauma who do not receive a PTSD diagnosis, those diagnosed with PTSD, and those diagnosed with CPTSD, as well as to examine the trauma history of their parents and the severity of their anxiety and depression. Furthermore, since there is no existing scale to assess CPTSD in children in our country, the study also aims to translate the International Trauma Questionnaire - Child and Adolescent Version into Turkish and evaluate its psychometric properties.
Read the detailed description
The study will be conducted under the coordination of the Department of Child and Adolescent Psychiatry at Istanbul Faculty of Medicine. The sample will consist of children and adolescents who have been identified by their attending physician as having experienced trauma and have been referred to participate in the study at the Child and Adolescent Psychiatry outpatient clinic of Istanbul Faculty of Medicine.
Sample:
- Children and adolescents aged 7-18,
- Children and adolescents who have experienced trauma and applied to the Child and Adolescent Psychiatry outpatient clinic of Istanbul Faculty of Medicine,
- 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)
Volunteer children and adolescents will complete:
- International Trauma Questionnaire - Child and Adolescent Version
- 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)
Afterward, volunteers included in the study will complete computer-based Emotion Recognition and Differentiation Tests.
For children exposed to trauma applying to the Istanbul Faculty of Medicine Child and Adolescent Mental Health and Disorders Clinic, psychiatric diagnoses will be shared with their physician upon patient approval. These children will be followed and treated in the clinic according to current guideline-recommended treatment methods.
The planned start date for the study is January 30, 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 June 2025.
The coordinating center responsible for the research is the Department of Child and Adolescent Mental Health and Disorders 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 Complex PTSD in Children and Adolescents Exposed to Trauma
The aim of this study is to conduct a psychiatric evaluation of children and adolescents exposed to trauma in the outpatient clinic and to determine the prevalence of PTSD and Complex PTSD (CPTSD) diagnoses.
Measured: Baseline
Examining the Differences Between Groups Who Do Not Have a PTSD Diagnosis, Those Diagnosed with PTSD, and Those Diagnosed with Complex PTSD (CPTSD)
The study aims to compare the clinical characteristics of children exposed to trauma who do not receive a PTSD diagnosis, those diagnosed with PTSD, and those diagnosed with CPTSD, as well as to examine the trauma history of their parents and the severity of their anxiety and depression. Additionally, it will also be examined whether there is a difference in facial emotion recognition skills among these groups.
Measured: Baseline
Adaptation of the International Trauma Questionnaire - Child and Adolescent Version into Turkish and Evaluation of Its Psychometric Properties
Since there is no existing scale in our country to assess CPTSD in children, the study also aims to translate the International Trauma Questionnaire - Child and Adolescent Version into Turkish and evaluate its psychometric properties.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start30 Jan 2025
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Post-Traumatic Stress Disorder (CPTSD)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
- 120 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 Cahid Orengul, Associate Professor, MD, Principal investigator, Istanbul Faculty of Medicine, Child and Adolescent Psychiatry Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918899
- Sponsor's protocol ID
- 2025/82
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Prevalence of Complex Post-Traumatic Stress Disorder in Trauma-Exposed Children and Adolescents and Examining Related Factors
- ClinicalTrials.gov ID
- NCT06918899
- Acronym / sponsor ID
- 2025/82
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 9 Apr 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.
The aim of this study is to assess the psychiatric evaluation of children and adolescents exposed to trauma in the outpatient clinic and to determine the prevalence of PTSD and Complex PTSD (CPTSD) diagnoses. Additionally, it aims to compare the clinical characteristics of children exposed to trauma who do not receive a PTSD diagnosis, those diagnosed with PTSD, and those diagnosed with CPTSD, as well as to examine the trauma history of their parents and the severity of their anxiety and depression. Furthermore, since there is no existing scale to assess CPTSD in children in our country, the study also aims to translate the International Trauma Questionnaire - Child and Adolescent Version into Turkish and evaluate its psychometric properties.
Detailed description
The study will be conducted under the coordination of the Department of Child and Adolescent Psychiatry at Istanbul Faculty of Medicine. The sample will consist of children and adolescents who have been identified by their attending physician as having experienced trauma and have been referred to participate in the study at the Child and Adolescent Psychiatry outpatient clinic of Istanbul Faculty of Medicine.
Sample:
- Children and adolescents aged 7-18,
- Children and adolescents who have experienced trauma and applied to the Child and Adolescent Psychiatry outpatient clinic of Istanbul Faculty of Medicine,
- 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)
Volunteer children and adolescents will complete:
- International Trauma Questionnaire - Child and Adolescent Version
- 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)
Afterward, volunteers included in the study will complete computer-based Emotion Recognition and Differentiation Tests.
For children exposed to trauma applying to the Istanbul Faculty of Medicine Child and Adolescent Mental Health and Disorders Clinic, psychiatric diagnoses will be shared with their physician upon patient approval. These children will be followed and treated in the clinic according to current guideline-recommended treatment methods.
The planned start date for the study is January 30, 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 June 2025.
The coordinating center responsible for the research is the Department of Child and Adolescent Mental Health and Disorders 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 Mental Health and Disorders Outpatient Clinic of Istanbul Faculty of Medicine
Key inclusion criteria (3 listed)
- Having been exposed to at least one traumatic event,
- Being between the ages of 7 and 18,
- The child and/or their parents (or caregivers) having adequate literacy and Turkish communication 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 Complex PTSD in Children and Adolescents Exposed to Trauma
Time frame: Baseline
The aim of this study is to conduct a psychiatric evaluation of children and adolescents exposed to trauma in the outpatient clinic and to determine the prevalence of PTSD and Complex PTSD (CPTSD) diagnoses.
Examining the Differences Between Groups Who Do Not Have a PTSD Diagnosis, Those Diagnosed with PTSD, and Those Diagnosed with Complex PTSD (CPTSD)
Time frame: Baseline
The study aims to compare the clinical characteristics of children exposed to trauma who do not receive a PTSD diagnosis, those diagnosed with PTSD, and those diagnosed with CPTSD, as well as to examine the trauma history of their parents and the severity of their anxiety and depression. Additionally, it will also be examined whether there is a difference in facial emotion recognition skills among these groups.
Adaptation of the International Trauma Questionnaire - Child and Adolescent Version into Turkish and Evaluation of Its Psychometric Properties
Time frame: Baseline
Since there is no existing scale in our country to assess CPTSD in children, the study also aims to translate the International Trauma Questionnaire - Child and Adolescent Version into Turkish and evaluate its psychometric properties.
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 9 Apr 2025.
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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 Cahid Orengul, Associate Professor, MD 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 Complex Post-Traumatic Stress Disorder (CPTSD) and Post-traumatic Stress Disorder (PTSD), 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 9 Apr 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 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?
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 9 Apr 2025.