跳至主要内容
临床试验/NCT07697534
NCT07697534进行中(未招募)不适用

Two-Year Follow-up Study on Children Exposed to Trauma

Istanbul University1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2026年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
136
试验地点
1
主要终点
Prevalence of PTSD and Complex PTSD in Children and Adolescents Exposed to Trauma

研究概览

简要总结

In our clinic, we plan to conduct research two years after the initial assessments (January-April 2024 and one year ago, January-June 2025) of children and adolescents with trauma exposure who were evaluated as part of their thesis studies. The aim is to re-evaluate these individuals to determine how many continue to receive a PTSD diagnosis, how many receive a diagnosis of K-PTSD, and what factors are associated with these changes. This research aims to contribute to the literature on the long-term effects of trauma exposure.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

结局指标

主要结局

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

时间窗: from january 2024 to august 2026

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.

Factors Associated with the Diagnosis of PTSD and Complex PTSD

时间窗: from march 2026 to august 2026

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Afife Özkal

MD

Istanbul University

研究点 (1)

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