Prevalence of Complex PTSD in Trauma-Exposed Children-Adolescents and Related Factors

NCT ID: NCT06918899

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-30
• Study Completion Date: 2025-07-31

Brief 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. 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.

Conditions

Complex Post-Traumatic Stress Disorder (CPTSD); Post-traumatic Stress Disorder (PTSD)

Study Design

• Observational Model Type: FAMILY_BASED
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Beyza Nur Karal

Research Assistant, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdurrahman Cahid Orengul, Associate Professor, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Faculty of Medicine, Child and Adolescent Psychiatry Department

Locations

Istanbul Faculty of Medicine

Istanbul, Fatih, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Beyza N Karal, MD

Role: CONTACT

beyzakaral@istanbul.edu.tr

+9002124142000

Facility Contacts

Beyza N Karal, MD

Role: primary

beyzakaral@istanbul.edu.tr

+9002124142000

Other Identifiers

2025/82

Identifier Type: -

Identifier Source: org_study_id