Post-Traumatic Stress Disorder in ChildrenNCT06077474
Validation of the Turkish Version of PTSD-RI-5
An observational study of Post-Traumatic Stress Disorder in Children, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Post-Traumatic Stress Disorder in Children
- What is being tested?
- Testing the the DSM-5 UCLA Posttraumatic Stress Disorder Reaction Index Self-Report Scale for Children and Adolescents (PTSD-RI-5)
- How many people
- 157 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2023to 24 Jul 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and Adolescents aged 11 and 17 with exposed to traumatic events
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Behcet Uz Pediatric Diseases And Surgery Training And Research Hospital
Izmir
About this study
Official title: 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.
Read the 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.
- Being tested
- Testing the the DSM-5 UCLA Posttraumatic Stress Disorder Reaction Index Self-Report Scale for Children and Adolescents (PTSD-RI-5)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing the the DSM-5 UCLA Posttraumatic Stress Disorder Reaction Index Self-Report Scale for Children and Adolescents (PTSD-RI-5)Other
Also called Severity of Post-Traumatic Stress Symptoms -Child aged 11-17 Post-Traumatic Stress Disorder National Stressful Events Survey Short Form (NSESSS)
Administer the DSM-5 PTSD-RI-5 scale in 155 patients with exposed to traumatic events.
| Study group | Role | What they receive |
|---|---|---|
| PTSD QUESTIONNAIRES | The group is anticipated to consist of in 155 patients who have been exposed to traumatic events. Receives: Other: Testing the the DSM-5 UCLA Posttraumatic Stress Disorder Reaction Index Self-Report Scale for Children and Adolescents (PTSD-RI-5) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Reliability of PTSD-RI-5
Test-retest reliability will be tested with intraclass correlation coefficient (ICC).
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start5 Oct 2023
- Primary completion17 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress Disorder in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 157 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melek Ince, Dr. Behcet Uz Children's Hospital
- Investigators
- Fatma S Durak, MD, Study chair, Dr. Behcet Uz Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077474
- Sponsor's protocol ID
- 38583858
- Status last verified
- Aug 2024
- First submitted
- 5 Oct 2023
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19360231Costello 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.
PubMed 12013070Kessler 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.
PubMed 7492257Dykman 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.
PubMed 9105915Yalin 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.
PubMed 29033631Laor 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.
PubMed 12486370Tsang 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.
PubMed 28616007Beaton 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.
PubMed 11124735Kaplow 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.
PubMed 30953734Tavakol 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.
PubMed 28029643Schober P, Boer C, Schwarte LA. Correlation Coefficients: Appropriate Use and Interpretation. Anesth Analg. 2018 May;126(5):1763-1768. doi: 10.1213/ANE.0000000000002864.
PubMed 29481436Ince M, Durak FS, Ince B, Steinberg A. Turkish UCLA PTSD-RI-5: Validation and the Role of Symptom Severity in Functional Impairment. Int J Methods Psychiatr Res. 2026 Sep;35(3):e70101. doi: 10.1002/mpr.70101.
PubMed 42559796
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06077474
- Acronym / sponsor ID
- 38583858
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTSD QUESTIONNAIRES | – | Other: Testing the the DSM-5 UCLA Posttraumatic Stress Disorder Reaction Index Self-Report Scale for Children and Adolescents (PTSD-RI-5)The group is anticipated to consist of in 155 patients who have been exposed to traumatic events. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and Adolescents aged 11 and 17 with exposed to traumatic events
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing the the DSM-5 UCLA Posttraumatic Stress Disorder Reaction Index Self-Report Scale for Children and Adolescents (PTSD-RI-5)Also: Severity of Post-Traumatic Stress Symptoms -Child aged 11-17 Post-Traumatic Stress Disorder National Stressful Events Survey Short Form (NSESSS)Administer the DSM-5 PTSD-RI-5 scale in 155 patients with exposed to traumatic events. | Other | PTSD QUESTIONNAIRES |
Primary outcome
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).
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).
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Background: PubMed 19360231Campo-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.
- Results publication: PubMed 12013070Costello 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.
- Results publication: PubMed 7492257Kessler 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.
- Results publication: PubMed 9105915Dykman 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.
- Results publication: PubMed 29033631Yalin 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.
- Results publication: PubMed 12486370Laor 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.
- Results publication: PubMed 28616007Tsang 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.
- Results publication: PubMed 11124735Beaton 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.
- Results publication: PubMed 30953734Kaplow 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.
- Results publication: PubMed 28029643Tavakol 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.
- Results publication: PubMed 29481436Schober P, Boer C, Schwarte LA. Correlation Coefficients: Appropriate Use and Interpretation. Anesth Analg. 2018 May;126(5):1763-1768. doi: 10.1213/ANE.0000000000002864.
- Derived from this study: PubMed 42559796Ince M, Durak FS, Ince B, Steinberg A. Turkish UCLA PTSD-RI-5: Validation and the Role of Symptom Severity in Functional Impairment. Int J Methods Psychiatr Res. 2026 Sep;35(3):e70101. doi: 10.1002/mpr.70101.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma S Durak, MD study chair
Dr. Behcet Uz Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Traumatic Stress Disorder in Children, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of PTSD-RI-5 (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06077474, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.