NCT06975852

Brief Summary

As far as it is known, there is no longitudinal study in Turkey investigating the follow-up and treatment of children and adolescents exposed to trauma. This study is planned to reassess children and adolescents with trauma exposure who were evaluated in Istanbul Faculty of Medicine Child Psychiatry outpatient clinic as part of a thesis study one year ago (January-April 2024) and to examine how many of them continue to meet the criteria for Post-Traumatic Stress Disorder (PTSD), how many receive a diagnosis of Complex Post-Traumatic Stress Disorder (CPTSD), and which factors are associated with these outcomes. In this way, it is aimed to contribute to the literature on the long-term effects of trauma exposure. Additionally, since there is no scale in our country that assesses the diagnosis of CPTSD in children, the study also aims to translate the Child and Adolescent Trauma Screen Scale - 2 (CATS-2) into Turkish and examine 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
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 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

February 17, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

April 25, 2025

Last Update Submit

May 13, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Prevalence of PTSD and Complex PTSD in Children and Adolescents Exposed to Trauma

    This study aims to investigate the prevalence of PTSD and CPTSD diagnoses one year after the initial assessment of trauma-exposed children and adolescents evaluated in our outpatient clinic between January and April 2024 as part of a thesis study.

    Baseline

  • 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, the child's PACE score, the parent's ACE and PACE scores, and the severity of parental anxiety and depression.

    Baseline

  • Adaptation of the Child and Adolescent Trauma Screen - 2 into Turkish, Evaluation of Its Psychometric Properties

    Given the absence of an existing instrument to assess CPTSD in children in Turkey, this study also aims to translate the Child and Adolescent Trauma Screen - 2 (CATS-2) into Turkish and to evaluate its psychometric properties. The results of both the self-report and caregiver-report versions of the Turkish CATS-2, completed by children/adolescents and their parents respectively, will be compared with PTSD and CPTSD diagnoses obtained through a clinician-administered ICD-11-based clinical interview, as well as with the results of the UCLA PTSD Reaction Index for DSM-5 (RI-5).

    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 Psychiatry outpatient clinic of Istanbul Faculty of Medicine

You may qualify if:

  • Children-adolescents who were exposed to at least one traumatic event and who were evaluated within the scope of the thesis study one year ago (January-April 2024),
  • Children and adolescents aged 7-18,
  • Children and/or parents with adequate literacy and Turkish language 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 C Orengul, Associate Professor

    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

April 25, 2025

First Posted

May 16, 2025

Study Start

February 17, 2025

Primary Completion

July 18, 2025

Study Completion

August 15, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

Locations