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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06077474
Other study ID # 38583858
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 5, 2023
Est. completion date December 2024

Study information

Verified date October 2023
Source Dr. Behcet Uz Children's Hospital
Contact Melek Ince, MD
Phone +905078562096
Email melek3858@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 155
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 11 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Testing the the DSM-5 UCLA Posttraumatic Stress Disorder Reaction Index Self-Report Scale for Children and Adolescents (PTSD-RI-5)
Administer the DSM-5 PTSD-RI-5 scale in 155 patients with exposed to traumatic events.

Locations

Country Name City State
Turkey Dr. Behcet Uz Pediatric Diseases And Surgery Training And Research Hospital Izmir

Sponsors (1)

Lead Sponsor Collaborator
Melek Ince

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 P — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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):2 — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Reliability of PTSD-RI-5 Internal consistency will be tested with Cronbach Alpha coefficient. Test-retest reliability will be tested with intraclass correlation coefficient (ICC). Baseline
Primary Reliability of PTSD-RI-5 Test-retest reliability will be tested with intraclass correlation coefficient (ICC). At the end of the 2nd week of study
Primary Correlation between the PTSD-RI-5 and Post-Traumatic Stress Disorder National Stressful Events Survey Short Form 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
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