"The effect of mindfulness based cognitive behavioral therapy for children (MBCT-C) on cognitive inhibition, emotional self-regulation, and behavioral problems of children with learning disabilities"
َA) General purpose:
Determining The effect of mindfulness based cognitive behavioral therapy for children on cognitive inhibition, emotional self-regulation, and behavioral problems of children with learning disabilities.
B) Specific goals:
1) Determination and comparison of cognitive inhibition of children with learning disabilities before and after intervention in two groups
2) Determination and comparison of emotion regulation of children with learning disabilities before and after the intervention in two groups
3) Determination and comparison of behavioral problems in children with learning disabilities before and after the intervention in two groups
Design
A clinical trial with a control group, purpose-based sampling, assigning participants to two groups randomly (table of random numbers), sample number 36 people.
Settings and conduct
Kashan learning disorder centers
Participants/Inclusion and exclusion criteria
Entry criteria:
1) Having a learning disorder based on the diagnosis of the child's psychiatrist/clinical psychologist
2) Having informed consent to participate in the research
3) Age 9 to 12 years
4) At least one of the nine diagnostic items in the learning disorder questionnaire received a positive score
Non-entry criteria:
1) Suffering from an acute physical and mental illness such as diabetes, cancer, bereavement, etc.
2) Receiving other types of psychotherapy
Intervention groups
Children in both intervention and control groups will continue their usual treatment, with the difference that the experimental group will undergo MBCT-C, which is in the form of 12 sessions of 90 minutes held once a week.
Also, the evidence group will be assured that they will also receive these interventions if they wish after completing the research process.
"The effect of mindfulness based cognitive behavioral therapy for children (MBCT-C) on cognitive inhibition, emotional self-regulation, and behavioral problems of children with learning disabilities"
Public title
"The effect of mindfulness based cognitive behavioral therapy for children on learning disorders"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a learning disorder based on the diagnosis of the child's psychiatrist or clinical psychologist
Having informed consent to participate in the research
Age 9 to 12 years
At least one of the 9 diagnostic items in the learning disorder questionnaire received a positive score
Exclusion criteria:
Suffering from acute physical and mental illness such as diabetes, cancer, bereavement and ..
Receiving various types of psychotherapy
Age
From 9 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Assigning participants to intervention and control groups is done by simple random (based on the table of random numbers), In this way, each participant will be assigned a number and with the help of "random.org/lists" they will be randomly assigned to two groups based on their number.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study has two experimental and control groups, children in both groups will continue their common treatment and after completing the treatment process (MBCT-C), the control group will also receive this intervention if they wish.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Kashan University Of Medical Sciences
Street address
Kashan University Of Medical Sciences., Pezashk Blvd., Qutb Rawandi Blvd., Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2024-06-29, 1403/04/09
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1403.081
Health conditions studied
1
Description of health condition studied
learning disorder
ICD-10 code
F81.9
ICD-10 code description
Developmental disorder of scholastic skills, unspecified
Primary outcomes
1
Description
Cognitive inhibition score in the Boshra Test
Timepoint
Before and after the intervention
Method of measurement
Boshra Test
2
Description
Emotion regulation score in child and adolescent emotion regulation questionnaire (ERQ-CA)
Timepoint
Before and after the intervention
Method of measurement
child and adolescent emotion regulation questionnaire (ERQ-CA)
3
Description
The score of behavioral problems in Child Behavior Checklist (CBCL), parent version
Timepoint
Before and after the intervention
Method of measurement
Child Behavior Checklist (CBCL), parent version
4
Description
The child's score in the learning disorder questionnaire(teacher form)
Timepoint
Before and after the intervention
Method of measurement
learning disorder questionnaire(teacher form)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this research, there is an intervention group with 18 children aged 9 to 12 years, and the children in this group will be treated with MBCT_C in addition to their usual treatment. mindfulness based cognitive behavioral therapy for children in the form of 12 90-minute sessions that are performed once a week.
Category
Rehabilitation
2
Description
Control group: In this research, there is a control group with 18 children aged 9 to 12 years, and the children in this group will continue their usual treatment, and they will also be assured that after completing the research process, if Will receive mindfulness based cognitive behavioral therapy for children.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Counseling and Psychological Services of Education and Training in Kashan
Full name of responsible person
Fateme Movahedian
Street address
Iqbal Lahori Alley., Shahid Rajaei St., Kashan
City
Kashan
Province
Isfehan
Postal code
8714753431
Phone
+98 31 5546 0013
Email
m_moshaverh48@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Kashan University of Medical Sciences., Pezeshk Blvd., Qutb Rawandi Blvd., Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
info@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Fateme Movahedian
Position
Master's Student In Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kashan University Of Medical Sciences., Pezeshk Blvd., Qutb Rawandi Blvd., Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
fatemeh.movahedian2233@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fateme Movahedian
Position
Master's Student In Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences., Pezashk Blvd., Qutb Rawandi Blvd., Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
0098 31 155109999
Email
fatemeh.movahedian2233@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fateme Movahedian
Position
Master's Student In Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences., Pezashk Blvd., Qutb Rawandi Blvd., Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
fatemeh.movahedian2233@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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