The effectiveness of applied behavioral analysis program and sensory enrichment on improving executive functions to Autistic children in Zahedan city 2018- 2019 .
Examine the effectiveness of the apply behavior analysis program and sensory enrichment on improve the executive functions in autistic children.
Design
This study included 24 autistic children in aged 3_6 years ,that selected randomly by random sampling and randomly assigned into three equal groups. All three groups had pre-test, intervention and post-test.post-test.
Settings and conduct
Research in the field of developmental neurological disorder (autism) in the autism center of the Well-being organization in Zahedan, Sistan-Baluchestan province. The sample is selected of the Autism Children's Society of this Center and divided into three groups, and each group will have a pre-test, intervention, and post-test. In the first group, the parent cares for the apply behavioral analysis and runs on his child. The second group of children's home environment is enriched by various sensory stimuli in five main areas. And in the third group, the parent sees and implements the apply behavioral analysis program, and the child's home environment is enriched by various sensory stimuli. And in all three groups, the impact of these interventions is measured on executive functions
Participants/Inclusion and exclusion criteria
Enter:
Autistic children in 3 to 6 years old.
Having educated parents.
Filling in the Satisfaction Questionnaire.
out:
Having mental retardation.
The autism children with sever body disability and epilepsy.
Intervention groups
This study consists of three intervention groups. For the first group, the Applied Behavioral Analysis Program is implemented by the trained care parent. The second group is enriching the child's environment From the aspects of sensory stimuli in all five sensory areas. The third group includes both interventions.
Main outcome variables
The components of executive functions that include:
1. Inhibition of response.
2-Planning.
3.Shifting of behavioral .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190420043334N1
Registration date:2019-05-24, 1398/03/03
Registration timing:retrospective
Last update:2019-05-24, 1398/03/03
Update count:0
Registration date
2019-05-24, 1398/03/03
Registrant information
Name
Asghar Khaqani Yamchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 4216 3329
Email address
as.khaqany@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-22, 1397/07/30
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
2018-10-25, 1397/08/03
Actual recruitment end date
2018-11-17, 1397/08/26
Trial completion date
2019-04-19, 1398/01/30
Scientific title
The effectiveness of applied behavioral analysis program and sensory enrichment on improving executive functions to Autistic children in Zahedan city 2018- 2019 .
Public title
The effectiveness of ََapplied behavioral analysis and sensory enrichment on improving executive functions.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Autistic children 3 to 6 years old referring to the Autism Center.
Having educated parents
Filling in the Satisfaction Questionnaire for attending meetings.
Exclusion criteria:
Having mental retardation.
The autism children with sever body disability and epilepsy.
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, Random number table will be used. According to the 24- sample size of the statistical population (children aged 3 to 6 are at the center of autism) will be selected, then with doing lottery they will be placed in 3 equal groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this research, each person is his own control.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Blvd.doctor hesabi
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743175
Approval date
2018-06-17, 1397/03/27
Ethics committee reference number
IR.ZAUMS.REC.1397.139
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
Executive functional of behavior planning.
Timepoint
The variable, first time before the program is measured, and the final measurement will be 14 weeks after intervention.
Method of measurement
Standard inventory for behavioral rating of executive function of preschool children in parental form.
2
Description
Executive functional of behavior inhibition.
Timepoint
The variable, first time before the program is measured, and the final measurement will be 14 weeks after intervention.
Method of measurement
Standard inventory for behavioral rating of executive function of preschool children in parental form.
3
Description
Executive functional of behavior shifting.
Timepoint
The variable, first time before the program is measured, and the final measurement will be 14 weeks after intervention.
Method of measurement
Standard inventory for behavioral rating of executive function of preschool children in parental form.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The applied behavioral analysis program will be implemented to children by trained parent for 12 weeks.
Category
Rehabilitation
2
Description
Intervention group 2: The sensory enrichment program will be implemented to children by trained parent for 12 weeks.
Category
Rehabilitation
3
Description
Intervention group 3: Both the applied behavior analysis and sensory enrichment programs will be implemented to children by trained parent for 12 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Autism center of welfare organization of Zahedan City, Sistan and baluchestan Provice.
Full name of responsible person
Asghar Khaqani Yamchi
Street address
No71, Blvd Shahid rajayi
City
Marand- Yamchi
Province
East Azarbaijan
Postal code
5439118119
Phone
+98 41 4216 3329
Email
as.khaqny@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Deputy of research and technology of Zahedan University of Medical Sciences.
Street address
Doctor Hessabi Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743173
Phone
+98 41 4216 3329
Email
as.khaqany@gmail.com
Grant name
No
Grant code / Reference number
ندارد
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Asghar Khaqani Ymchi
Position
Msc, student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Blvd Doctor Hessabi
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
5439118119
Phone
+98 41 4216 3329
Email
as.khaqany@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Asghar Khaqani Yamchi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No.71, Shahid Hossen Yadolahi , St.Shahid Rajayi
City
Marand- Yamchi
Province
East Azarbaijan
Postal code
5439118119
Phone
+98 41 4216 3329
Email
as.khaqany@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Asghar Khaqani Yamchi
Position
Msc, Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No.71, Shahid Hossen Yadollahi, St. Shahid Rajayi
City
Marand- Yamchi
Province
East Azarbaijan
Postal code
5439118119
Phone
+98 41 4216 3329
Email
as.khaqany@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
In this clinical trial whole research data upload to other researchers.
When the data will become available and for how long
2019/06/21-2020/06/21
To whom data/document is available
All researcher children.
Under which criteria data/document could be used
For clinical and research.
From where data/document is obtainable
The journal of publication paper.
What processes are involved for a request to access data/document
You can email request and researcher will provide for you.