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The efficacy of Trauma-focused cognitive behavioral therapy on reducing trauma symptoms and improving cognitive function in children with posttraumatic stress symptoms

Protocol summary

Study aim
The efficacy of Trauma-focused cognitive behavioral therapy on reducing trauma symptoms and improving cognitive function in children with posttraumatic stress symptoms
Design
Clinical trial with a control group (n = 17) and an intervention group (n = 17), sample size including 34 subjects, randomized through rolling the dice(Eligible individuals are divided into control and intervention groups by rolling the dice).
Settings and conduct
Due to the prevalence of Covid-19 disease, sampling Sampling will be done in absentia and through virtual pages(Rubika, Instagram, WhatsApp). Sampling is done among the people who contact the researcher and want to participate in the research according to the entry and exit criteria.
Participants/Inclusion and exclusion criteria
Entry criteria:1-Trauma history (grief,sexual abuse,natural disasters,accidents); 2-Having symptoms associated with trauma and post traumatic stress; 3-Being in the range of 7 to 13 years; 4-Not attending psychotherapy courses for at least one year ago Exit criteria: 1-Simultaneous diagnosis of autism spectrum disorder, intellectual disorder, childhood psychosis, major depressive disorder in childhood, severe childhood mania, conduct disorder, severe bipolar disorder; 2-Acute psychiatric disorder of parents participating in treatment; 3-Use any psychotropic drugs; 4-Need psychiatric emergencies.
Intervention groups
Intervention group: Individuals in this group receive 16 sessions of 90 minutes, three sessions per week, for trauma-based cognitive-behavioral therapy. In this study, a 16-session protocol of this treatment was used. Control group: During the study, members of this group are on the waiting list and after completion, they receive the same treatment as the intervention group.
Main outcome variables
Trauma symptoms؛ attention؛ inhibition

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190701044063N1
Registration date: 2021-02-11, 1399/11/23
Registration timing: retrospective

Last update: 2021-02-11, 1399/11/23
Update count: 0
Registration date
2021-02-11, 1399/11/23
Registrant information
Name
Negar Bagher
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3631 4479
Email address
negar7178@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Trauma-focused cognitive behavioral therapy on reducing trauma symptoms and improving cognitive function in children with posttraumatic stress symptoms
Public title
Childhood trauma treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Trauma history (grief,sexual abuse,natural disasters,accidents) Having symptoms associated with trauma and post traumatic stress Being in the range of 7 to 13 years Not attending psychotherapy courses for at least one year ago
Exclusion criteria:
Simultaneous diagnosis of autism spectrum disorder, intellectual disorder, childhood psychosis, major depressive disorder in childhood, severe childhood mania, conduct disorder, severe bipolar disorder Acute psychiatric disorder of parents participating in treatment Use any psychotropic drugs Need psychiatric emergencies
Age
From 7 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals are divided into control and intervention groups by rolling the dice.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research, University of Social Welfare and Rehabilitation Sciences
Street address
Koodak Yar Deadlock, Daneshjoo Blvd, Evin, Tehran, University of Social Welfare and Rehabilitation Sciences
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Approval date
2020-02-25, 1398/12/06
Ethics committee reference number
IR.USWR.REC.1399.019

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 Symptoms
Timepoint
Before intervention, 3 to 7 days after intervention
Method of measurement
Parent Report of Post-traumatic Stress Symptoms, Child Report of Post-traumatic Symptoms

2

Description
Cognitive function
Timepoint
Before intervention, 3 to 7 days after intervention
Method of measurement
Emotional stroop

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Individuals in this group receive 16 sessions of 90 minutes, three sessions per week, for trauma-based cognitive-behavioral therapy. In this study, a 16-session protocol of this treatment was used. Session 1: Psychological education. Session 2: Parenting. Session 3: Relaxation. Session 4: Affect Identification & Regulation. Sessions 5 and 6: Cognitive Coping. Sessions 7 and 8: Trauma Processing and Narration Part I. Sessions 9, 10, and 11: Trauma Processing and Narration Part II. Sessions 12, 13, and 14: in vivo mastery. Session 15: Conjoint Parent-Child Sessions. Session 16: Enhancing Safety & Future Development
Category
Treatment - Other

2

Description
Control group: During the study, members of this group are on the waiting list and after completion, they receive the same treatment as the intervention group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Nezam Mafi Rehabilitation Medical Center
Full name of responsible person
Negar Bagher
Street address
1st W, W, South Jannat Abad, Tehran, Tehran Province
City
Karaj
Province
Tehran
Postal code
1969615533
Phone
+98 21 4403 8755
Email
negar7178@yahoo.com

2

Recruitment center
Name of recruitment center
social media
Full name of responsible person
Negar Bagher
Street address
Alborz, Mohammadshahr, Homayoun Villa, Alavi St., Daneshvar Alley, Naghsh Jahan Building 3, Unit 25
City
Karaj
Province
Alborz
Postal code
318461211
Phone
+98 26 3631 4479
Email
negar7178@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamid Reza Khankeh
Street address
Alborz, Mohammadshahr, Homayoun Villa, Alavi St., Daneshvar Alley, Naghsh Jahan Building 3, Unit 25
City
Tehran
Province
Tehran
Postal code
318461211
Phone
+98 26 3631 4479
Email
negar7178@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Negar Bagher
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Alborz, Mohammadshahr, Homayoun Villa, Alavi St., Daneshvar Alley, Naghsh Jahan Building 3, Unit 25
City
Karaj
Province
Alborz
Postal code
318461211
Phone
+98 26 3631 4479
Email
negar7178@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Negar Bagher
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Alborz, Mohammadshahr, Homayoun Villa, Alavi St., Daneshvar Alley, Naghsh Jahan Building 3, Unit 25
City
Karaj
Province
Alborz
Postal code
318461211
Phone
+98 26 3136 4479
Email
negar7178@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Negar Bagher
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Alborz, Mohammadshahr, Homayoun Villa, Alavi St., Daneshvar Alley, Naghsh Jahan Building 3, Unit 25
City
Karaj
Province
Alborz
Postal code
318461211
Phone
+98 26 3631 4479
Email
negar7178@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is 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
release schedule is not yet known.
When the data will become available and for how long
After completing the research
To whom data/document is available
Researchers and scientific centers
Under which criteria data/document could be used
Trauma and treatment centers
From where data/document is obtainable
negar7178@yahoo.com
What processes are involved for a request to access data/document
The request will be checked by email and sent if necessary.
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