Effect of traumatic cognitive-behavioral therapy on the reduction of posttraumatic stress syndrome and behavioral problems in surviving children from the earthquake in Kermanshah
Assessing the effect of early trauma-focused cognitive behavioral method on post-traumatic stress disorder and behavioral problems in children who survived of the earthquake in Kermanshah city
Design
This study is an open lable clinical trial. 60 persons will selected in available method and randomly will be divided into two groups (30 patients experimental group and 30 patients in control group).
Settings and conduct
The study population will consisted of all earthquake children in Kermanshah city that 60 persons will selected in available method and randomly will be divided into two groups (30 patients experimental group and 30 patients in control group). The experimental and control group will completed the Post traumatic stress disorder and children's behavioral problems questionnaires. The experimental group will received group training trauma-focused cognitive behavioral therapy 8 sessions and the control group will not receive any tests. both groups will compared in terms of Post traumatic stress disorder and behavioral problems . After the end of the study in order to maintain ethics and the rights of research participants,Control group also will received group early trauma-focused cognitive behavioral method .
Participants/Inclusion and exclusion criteria
Inclusion criteria: lack of serious psychiatric disorders.
Exclusion criteria: The absence of comorbid psychiatric disorders symptoms.
Intervention groups
The experimental group will undergo trauma-focused cognitive behavioral therapy in 8 sessions per hour
Main outcome variables
Post traumatic stress disorder and behavioral problems
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160717028967N6
Registration date:2018-05-17, 1397/02/27
Registration timing:registered_while_recruiting
Last update:2018-05-17, 1397/02/27
Update count:0
Registration date
2018-05-17, 1397/02/27
Registrant information
Name
Safora Salemi
Name of organization / entity
Shahid Chamran University of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 83 3821 1001
Email address
e.mahmoudi@cobeldarou.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of traumatic cognitive-behavioral therapy on the reduction of posttraumatic stress syndrome and behavioral problems in surviving children from the earthquake in Kermanshah
Public title
Treatment for surviving children from the earthquake
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
lack of serious psychiatric disorders
Exclusion criteria:
The absence of comorbid psychiatric disorders symptoms
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medic Building No.2, Shahid Beheshti Blvd, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Approval date
2017-12-13, 1396/09/22
Ethics committee reference number
kums.rec.1396.509
Health conditions studied
1
Description of health condition studied
Post-traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder
Primary outcomes
1
Description
Post traumatic stress disorder
Timepoint
Baseline and two months after intervention
Method of measurement
Post traumatic stress disorder questionnaire
2
Description
behavioral problems
Timepoint
Baseline and two months after intervention
Method of measurement
behavioral problems questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The experimental group will receive trauma-focused cognitive-behavioral intervention in 8sessions.
Category
Behavior
2
Description
Control group: The control group will not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Schools
Full name of responsible person
Sahnaz Mahmoudi
Street address
Noor School, Resalat Town, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6610785471
Phone
+98 83 3721 0277
Email
s_salemi85@yahoo.vom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti Blvd, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83 3836 1400
Email
khamzehee@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Vahid Farnia
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farabi Hospital, Isar square
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83382610700
Email
vfarnia@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Vahid Farnia
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farabi Hospital, Isar square
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83 3826 4513
Email
vfarnia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Safora Salemi
Position
teacher
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Social Science, Opp to Ayatollah Taleghani Hospital, Shahid Beheshti Blvd,Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6719851115
Phone
+98 83 3821 1001
Email
s_salemi85@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
I have no plans at this time
When the data will become available and for how long
I have no plans at this time
To whom data/document is available
I have no plans at this time
Under which criteria data/document could be used
I have no plans at this time
From where data/document is obtainable
I have no plans at this time
What processes are involved for a request to access data/document