Protocol summary

Study aim
Comparison of the mindfulness-based cognitive therapy (MBCT) and cognitive- behavioral play therapy (CBPT) on anxiety, attention control and emotional regulation
Design
Multivariate analysis of covariance (MANCOVA) with SPSS software will be used to analyze the data obtained from the research.
Settings and conduct
The intervention is done in the school and as a group control and intervention
Participants/Inclusion and exclusion criteria
- Children 8-12 years old - Not having a physical or mental illness (through the initial screening that will be done by the counselor and school teacher) - A resident of Tehran - Not taking medicine - Not using psychological and psychotherapy services while participating in the program
Intervention groups
(CBPT) Comparison of cognitive therapy based on mindfulness
Main outcome variables
Examining anxiety, controlled attention and emotional regulation of children

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230922059488N1
Registration date: 2023-12-20, 1402/09/29
Registration timing: retrospective

Last update: 2023-12-20, 1402/09/29
Update count: 0
Registration date
2023-12-20, 1402/09/29
Registrant information
Name
Habibeh Kholghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 3656
Email address
habibehkholghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the mindfulness-based cognitive therapy (MBCT) and cognitive- behavioral play therapy (CBPT) on anxiety, attention control and emotional regulation
Public title
indfulness-based cognitive therapy (MBCT) and cognitive- behavioral play therapy (CBPT)
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
child
Exclusion criteria:
Having physical and mental illness
Age
From 34 years old to 34 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Environmental research
Street address
Tehran Ave Golha
City
Tehran
Province
Tehran
Postal code
1413874415
Approval date
2023-09-17, 1402/06/26
Ethics committee reference number
IR.IAU.TNB.REC.1402.067

Health conditions studied

1

Description of health condition studied
Disorders of psychological development
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Children's score in anxiety test, cognitive regulation test and controlled attention
Timepoint
he effect of therapeutic intervention after 12 sessions
Method of measurement
questionnaire

Secondary outcomes

1

Description
Children's mental health score
Timepoint
After 12 sessions of therapeutic intervention
Method of measurement
questionnaire

2

Description
Children's attention control score
Timepoint
After 12 sessions of therapeutic intervention
Method of measurement
Attention control questionnaire

3

Description
Emotional regulation score
Timepoint
After 12 sessions of therapeutic intervention
Method of measurement
Emotional regulation questionnaire

4

Description
Anxiety score
Timepoint
After 12 sessions of therapeutic intervention
Method of measurement
Anxiety questionnaire

Intervention groups

1

Description
Intervention group: mindfulness-based cognitive therapy (MBCT)
Category
Behavior

2

Description
Control group: Cognitive and behavioral play therapy
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
dr mojtaba habibi
Street address
Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1413874414
Phone
+98 21 8800 3656
Email
habibi.m@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Mojtaba Habibi
Street address
Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 1021
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad university
Proportion provided by this source
10
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Mojtaba Habibi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1413874414
Phone
+98 21 8800 3656
Email
habibi.m@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojtaba habibi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1413874414
Phone
+98 21 8800 3656
Email
habibi.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojtaba habibi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No 7, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1413874414
Phone
009888005686
Email
habibi.m@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Statistical information of children's scores in psychological tests
When the data will become available and for how long
one year
To whom data/document is available
Judges and researchers
Under which criteria data/document could be used
Future research
From where data/document is obtainable
Author
What processes are involved for a request to access data/document
organizational process
Comments
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