- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06077474
Validation of the Turkish Version of PTSD-RI-5
August 29, 2024 updated by: Melek Ince, Dr. Behcet Uz Children's Hospital
Validation and Reliability of the Turkish Version of the UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index (RI) for The Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Self Report for Children and Adolescents
The aim of this study is to investigate the adaptation and validity of the DSM-5 PTSD-RI -5 scale in patients who have been exposed to traumatic events.
Thus, a scale useful for the diagnosis and follow-up of PTSD will be presented to the Turkish population.
Study Overview
Status
Completed
Conditions
Detailed Description
Children worldwide are at risk of experiencing psychological trauma.
In addition, one in every four children experiences major traumatic events such as domestic, school, or social violence, abuse, vehicle accidents, serious medical diseases, terrorist incidents, and war.
These difficult experiences increase the incidence of post-traumatic stress disorder in children.
It is reported that approximately 30% of children who have been exposed to trauma develop post-traumatic stress disorder.
Although it is sometimes difficult to diagnose post-traumatic stress disorder, it is important to detect symptoms of PTSD in children and adolescents early.
Many internalizing and externalizing symptoms occur in PTSD; There may be separation anxiety, shame, guilt, low tolerance, overstimulation, impulsivity, outbursts of anger, hostility, defiance, aggression, irritability, and mood changes.
Therefore, early evaluation of trauma experience and post-traumatic symptoms in children and adolescents seems important.
Study Type
Observational
Enrollment (Actual)
157
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İzmir, Turkey
- Dr. Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Children and Adolescents aged 11 and 17 with exposed to traumatic events
Description
Inclusion Criteria:
- Being a child or adolescent between the ages of 11-17
- To have experience a traumatic event in the past
- To have cognitive capacity to understand and complete the survey.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
PTSD QUESTIONNAIRES
The group is anticipated to consist of in 155 patients who have been exposed to traumatic events.
|
Administer the DSM-5 PTSD-RI-5 scale in 155 patients with exposed to traumatic events.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reliability of PTSD-RI-5
Time Frame: Baseline
|
Internal consistency will be tested with Cronbach Alpha coefficient.
Test-retest reliability will be tested with intraclass correlation coefficient (ICC).
|
Baseline
|
|
Reliability of PTSD-RI-5
Time Frame: At the end of the 2nd week of study
|
Test-retest reliability will be tested with intraclass correlation coefficient (ICC).
|
At the end of the 2nd week of study
|
|
Correlation between the PTSD-RI-5 and Post-Traumatic Stress Disorder National Stressful Events Survey Short Form
Time Frame: Baseline
|
The Spearman Correlation Analysis will be used for the correlation between between the PTSD-RI-5 and Post-Traumatic Stress Disorder National Stressful Events Survey Short Form
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Fatma S Durak, MD, Dr. Behcet Uz Children's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60. doi: 10.1001/archpsyc.1995.03950240066012.
- Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
- Campo-Arias A, Oviedo HC. [Psychometric properties of a scale: internal consistency]. Rev Salud Publica (Bogota). 2008 Nov-Dec;10(5):831-9. doi: 10.1590/s0124-00642008000500015. Spanish.
- Costello EJ, Erkanli A, Fairbank JA, Angold A. The prevalence of potentially traumatic events in childhood and adolescence. J Trauma Stress. 2002 Apr;15(2):99-112. doi: 10.1023/A:1014851823163.
- Dykman RA, McPherson B, Ackerman PT, Newton JE, Mooney DM, Wherry J, Chaffin M. Internalizing and externalizing characteristics of sexually and/or physically abused children. Integr Physiol Behav Sci. 1997 Jan-Mar;32(1):62-74. doi: 10.1007/BF02688614.
- Yalin Sapmaz S, Ergin D, Ozek Erkuran H, Sen Celasin N, Ozturk M, Karaarslan D, Koroglu E, Aydemir O. Validity and Reliability of the Turkish Version of the DSM-5 Posttraumatic Stress Symptom Severity Scale-Child Form. Noro Psikiyatr Ars. 2017 Sep;54(3):205-208. doi: 10.5152/npa.2017.15913. Epub 2016 Sep 1.
- Laor N, Wolmer L, Kora M, Yucel D, Spirman S, Yazgan Y. Posttraumatic, dissociative and grief symptoms in Turkish children exposed to the 1999 earthquakes. J Nerv Ment Dis. 2002 Dec;190(12):824-32. doi: 10.1097/00005053-200212000-00004.
- Tsang S, Royse CF, Terkawi AS. Guidelines for developing, translating, and validating a questionnaire in perioperative and pain medicine. Saudi J Anaesth. 2017 May;11(Suppl 1):S80-S89. doi: 10.4103/sja.SJA_203_17.
- Kaplow JB, Rolon-Arroyo B, Layne CM, Rooney E, Oosterhoff B, Hill R, Steinberg AM, Lotterman J, Gallagher KAS, Pynoos RS. Validation of the UCLA PTSD Reaction Index for DSM-5: A Developmentally Informed Assessment Tool for Youth. J Am Acad Child Adolesc Psychiatry. 2020 Jan;59(1):186-194. doi: 10.1016/j.jaac.2018.10.019. Epub 2019 Apr 3.
- Tavakol M, Dennick R. Making sense of Cronbach's alpha. Int J Med Educ. 2011 Jun 27;2:53-55. doi: 10.5116/ijme.4dfb.8dfd. No abstract available.
- Schober P, Boer C, Schwarte LA. Correlation Coefficients: Appropriate Use and Interpretation. Anesth Analg. 2018 May;126(5):1763-1768. doi: 10.1213/ANE.0000000000002864.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 5, 2023
Primary Completion (Actual)
July 17, 2024
Study Completion (Actual)
July 24, 2024
Study Registration Dates
First Submitted
October 5, 2023
First Submitted That Met QC Criteria
October 5, 2023
First Posted (Actual)
October 11, 2023
Study Record Updates
Last Update Posted (Actual)
September 3, 2024
Last Update Submitted That Met QC Criteria
August 29, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38583858
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post-Traumatic Stress Disorder in Children
-
University of UtahEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedPost-Traumatic Stress Disorder in Children | Post-Traumatic Stress Disorder in AdolescenceUnited States
-
University of California, Los AngelesWithdrawnPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder in ChildrenUnited States
-
University of NottinghamNottinghamshire Healthcare NHS Trust; Lincolnshire Partnership NHS Foundation...CompletedDomestic Violence | Trauma, Psychological | Post-Traumatic Stress Disorder in Children | Narrative Exposure Therapy | Post-Traumatic Stress Disorder in Adolescence | Post-Traumatic Stress Disorder ComplexUnited Kingdom
-
Association for Children at RiskGeha Mental Health CenterTerminatedPost-Traumatic Stress Disorder in ChildrenIsrael
-
Duke UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedPost Traumatic Stress Disorder | Hospitalism in ChildrenUnited States
-
Kronoberg County CouncilStiftelsen Allmänna BarnhusetEnrolling by invitationChild Abuse | Parent-Child Relations | Child Neglect | Post-Traumatic Stress Disorder in ChildrenSweden
-
IWK Health CentreRecruitingPost-Traumatic Stress Disorder in Adolescence | Post-Traumatic Stress Disorder, PTSD | Post-Traumatic Stress Disorder in YouthCanada
-
University Children's Hospital, ZurichCantonal Hospital Winterthur, Switzerland; University Clinic for Child and... and other collaboratorsRecruitingPTSD - Post Traumatic Stress Disorder | PTSD-Related Functional Impairment in Children and AdolescentsSwitzerland, Germany
-
University of California, Los AngelesWithdrawnPost Traumatic Stress Disorder | Post-Traumatic Stress Disorder in AdolescenceUnited States
-
University of California, Los AngelesWithdrawnPost Traumatic Stress Disorder | Post-Traumatic Stress Disorder in AdolescenceUnited States
Clinical Trials on Testing the the DSM-5 UCLA Posttraumatic Stress Disorder Reaction Index Self-Report Scale for Children and Adolescents (PTSD-RI-5)
-
The University of Texas Health Science Center at...National Institute of Mental Health (NIMH); Hearing Center of ExcellenceCompletedPosttraumatic Stress Disorder | TinnitusUnited States