NCT06077474

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

October 5, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2024

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

October 5, 2023

Last Update Submit

August 29, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

PTSD QUESTIONNAIRES

The group is anticipated to consist of in 155 patients who have been exposed to traumatic events.

Other: Testing the the DSM-5 UCLA Posttraumatic Stress Disorder Reaction Index Self-Report Scale for Children and Adolescents (PTSD-RI-5)

Interventions

Administer the DSM-5 PTSD-RI-5 scale in 155 patients with exposed to traumatic events.

Also known as: Severity of Post-Traumatic Stress Symptoms -Child aged 11-17 Post-Traumatic Stress Disorder National Stressful Events Survey Short Form (NSESSS)
PTSD QUESTIONNAIRES

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children and Adolescents aged 11 and 17 with exposed to traumatic events

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Behcet Uz Pediatric Diseases And Surgery Training And Research Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (11)

  • 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.

    PMID: 19360231BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Officials

  • Fatma S Durak, MD

    Dr. Behcet Uz Children's Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 11, 2023

Study Start

October 5, 2023

Primary Completion

July 17, 2024

Study Completion

July 24, 2024

Last Updated

September 3, 2024

Record last verified: 2024-08

Locations