Social cognition dysfunction in children with high functioning autism disorder: evaluation, developing program based on remediation and compensation strategies and study on its effectiveness on theory of mind ability and executive function
Investigating and comparing cognitive rehabilitation based on remediation and compensation strategies and study on its effectiveness on theory of mind ability and executive function
Design
the present study was on sub-experimental study with pretest and posttest design and a control group. Individuals who were diagnosed with autism were randomly divided into two intervention groups and one control group. The size of each group is 20 people.
Settings and conduct
Among children with autism in autistic children centers in Tehran, 80 children were selected using screening tests. participants are randomly assigned to one of three study groups (remediation, compensation, remediation-compensation ) and receive the intervention of the same groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: گروهDiagnosis of autism according to the Gilliam test, clinical interview based on DSM-5. Age (in the age range of 4 to7 years).above 80 according to Wechsler 3don't poor vision or hearing based on the child's record Parent consent to participate in the study. Exclusion criteria Attending therapeutic sessions or psychotherapy training concurrently, Absence of more than two sessions, Not willing to continue attending meetings.
Intervention groups
first group: cognitive rehabilitation based on remediation and compensation strategies
second group: cognitive rehabilitation based on remediation strategies
third group: cognitive rehabilitation based on compensation strategies
Main outcome variables
capacity of theory of mind
executive functions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210619051618N1
Registration date:2021-11-01, 1400/08/10
Registration timing:registered_while_recruiting
Last update:2021-11-01, 1400/08/10
Update count:0
Registration date
2021-11-01, 1400/08/10
Registrant information
Name
Fatemeh Abadi
Name of organization / entity
Institute for Cognitive Science Studies
Country
Iran (Islamic Republic of)
Phone
+98 21 8833 5133
Email address
abadi_f@iricss.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-24, 1400/08/02
Expected recruitment end date
2021-12-23, 1400/10/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Social cognition dysfunction in children with high functioning autism disorder: evaluation, developing program based on remediation and compensation strategies and study on its effectiveness on theory of mind ability and executive function
Public title
Comparison of effectiveness of cognitive rehabilitation based on remediation and compensation strategies on theory of mind and executive function in preschool children with autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
used participants between the ages of 4 and 7 years with autism spectrum disorder
diagnosis of autism based on DSM-V criteria
IQ above 80 according to Wechsler 3
don't poor vision or hearing based on the child's record
Parent consent to participate in the study
Exclusion criteria:
history of seizures
Receive simultaneous study
Reluctance to continue attending meetings
Age
From 4 years old to 7 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
participant who met the inclusion and exclusion criteria were randomly divided into three groups of first intervention, second intervention and control by online generating random numbers (calculator.net/random-number-generator). In the random numbers program, the numbers range was set from 1 to 60, and by choosing no duplicates, we request the production of three sets of random numbers, which are assigned to each group according to visit number of the people. This allocation is concealed from researchers and participant.
Blinding (investigator's opinion)
Double blinded
Blinding description
Not blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kharazmi university
Street address
KhU, No. 43. South Mofatteh Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۹۱۱-۱۵۷۱۹
Approval date
2021-02-13, 1399/11/25
Ethics committee reference number
IR.UT.IRICSS.REC.1399.011
Health conditions studied
1
Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Mind Theory score, which is measured through the Mind Theory Scale, Stirman et al.'S Mind Theory, and Mind Theory Stories questionnaires.
Timepoint
Components of theory of mind at the beginning of the study before the intervention and will be measured three months after the start of the study after the intervention and one month after the last intervention
Method of measurement
theory of mind is measured through the theory of mind Scale Questionnaire, the theory of mind Test, theory of mind stories.
2
Description
Executive functions score, which is measured through the dimond's shape span, Missing scan test, shape school, day and night stroop,TRAIL-P.
Timepoint
executive functions at the beginning of the study before the intervention and will be measured three months after the start of the study after the intervention and one month after the last intervention.
Method of measurement
executive function is measured dimond's shape span, Missing scan test, shape school, day and night stroop,TRAIL-P.
Secondary outcomes
1
Description
Behavioral dimensions of theory of mind
Timepoint
Behavioral dimensions of theory of mind at the beginning of the study before the intervention and will be measured three months after the start of the study after the intervention and one month after the last intervention.
Method of measurement
Behavioral dimensions of theory of mind is measured Theory of Mind Inventory.
2
Description
Behavioral dimensions of executive function
Timepoint
Behavioral dimensions of executive function at the beginning of the study before the intervention and will be measured three months after the start of the study after the intervention and one month after the last intervention.
Method of measurement
Behavioral dimensions of executive function is measured Behavioral Rating Executive Function Questionnaire Preschool(BRIEF-P).
Intervention groups
1
Description
Intervention group 1 : program based on remediation strategies. The treatment protocol consists of 18 one-hour sessions. The theory of mind training package based on the basics of mind theory and is designed according to the evolutionary and multidimensional approach of "theory of mind". training package is designed according to the evolutionary and multidimensional approach of "theory of mind".
Category
N/A
2
Description
Intervention group 2 : program based on compensation strategies. Rehabilitation package for executive functions in children with autism: In this program, based on theories, the basis of executive functions and cognitive rehabilitation, inhibitory control, working memory and cognitive flexibility are targeted.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Brain and Cognition Clinic
Full name of responsible person
Alireza Moradi
Street address
Brain and Cognition Clinic, No. 33,East Zartosht, Valiasr Stt, Valiasr St
City
Tehran
Province
Tehran
Postal code
1594834111
Phone
+98 21 8880 2063
Fax
+98 21 8880 2063
Email
info@bcclinic.ir
Web page address
https://bcclinic.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cognitive Sciences and Technologies Council
Full name of responsible person
Majid Nili Ahmadabadi
Street address
No 35, CSTC Building, Alvand St, Argentina Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1658344575
Phone
+98 21 8819 4956
Fax
+98 21 8819 4954
Email
info@cogc.ir
Web page address
https://cogc.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
cognitive sciences and technologies council
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
Institute for Cognitive Science Studies
Full name of responsible person
Alireza Moradi
Position
Ph.D, Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Phase 4 of Pardis City, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1658344575
Phone
+98 21 7629 1130
Fax
+98 21 7629 1140
Email
moradi90@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Institute for Cognitive Science Studies
Full name of responsible person
Fateme Abadi
Position
Ph.D, student, Cognitive Science, Institute for Cognitive Science Studies
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Phase 4 of Pardis City, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1658344575
Phone
+98 21 7629 1130
Fax
+98 21 7629 1140
Email
psy.abadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Institute for Cognitive Science Studies
Full name of responsible person
Fateme Abadi
Position
Ph.D, student, Cognitive Science, Institute for Cognitive Science Studies
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Phase 4 of Pardis City, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1658344575
Phone
+98 21 7629 1130
Fax
+98 21 7629 1140
Email
psy.abadi@gmail.com
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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
data file, study protocol, informed consent form and clinical study reports after unidentifiable people is shareable
When the data will become available and for how long
The beginning of the access period is 1 year after the publication of the results.
To whom data/document is available
data of this research will be available only for researchers that working in universities.
Under which criteria data/document could be used
Use of the data is allowed only for review articles.
From where data/document is obtainable
fateme abadi
Mobile number: 00 98 9123138621
Email:psy.abadi@gmail.com
Address:Phase 4 of Pardis City, Tehran, Iran
What processes are involved for a request to access data/document
Researchers who want to access the data must get a letter from the university at their place of work and send to the responsible person's email address, then the data will be available in less than 1 month.