NCT06918899

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

March 20, 2025

Last Update Submit

April 2, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients applying to the Child and Adolescent Mental Health and Disorders Outpatient Clinic of Istanbul Faculty of Medicine

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Faculty of Medicine

Istanbul, Fatih, 34116, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Abdurrahman Cahid Orengul, Associate Professor, MD

    Istanbul Faculty of Medicine, Child and Adolescent Psychiatry Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, MD

Study Record Dates

First Submitted

March 20, 2025

First Posted

April 9, 2025

Study Start

January 30, 2025

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

April 9, 2025

Record last verified: 2025-04

Locations