The efficacy of emotional diet intervention on behavioral and electrophysiological changes in young children with autism symptoms exposed to digital nanning
In this study, we investigate the effect of emotional diet intervention (parent-child emotional communications improvement and care style correction) on electrophysiological (QEEG) changes and behavioral symptoms improvement of young children who have exposed to digital nanning and have autism symptoms.
Design
In this research, 30 eligible children with autism symptoms, who referring to Ava autism center, choose. The children assign randomly into two intervention group.
Settings and conduct
After selecting the sample group, pre-test will take at the Children's Medical Center and the intervention provide in the center of Tehran Autism, and the post-test and follow up will take again in the Children's Medical Center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The child is exposed to digital devices for most of waking hours
(direct exposure to active and passive digital devices), The ages between 2- 6؛ Exclusion criteria: Receive simultaneous intervention.
Intervention groups
The first intervention group: In this group, we remove digital devices from the child's life and they received emotional diet intervention for two months.
The second group intervention: In this group, only digital devices removed from the child's life and intervention is not provided.
The efficacy of emotional diet intervention on behavioral and electrophysiological changes in young children with autism symptoms exposed to digital nanning
Public title
The impact of digital devices on the brain and the behavior of young children and their treatment by enriching the parent-child relationship
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The child beexposed to most of his waking hours directly to digital devices (in direct connection with active and passive digital devices).
The child be between 2 and 6 years of age.
Exclusion criteria:
The child simultaneously with this intervention reciving other rehabilitation.
Age
From 2 years old to 6 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
Individuals are randomly assigned to one of two study groups with the help of a random number table and receive the intervention of the same group.
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
Ethics committee of Shahid Beheshti University
Street address
Institute for Cognitive & Brain Sciences, Shahid Beheshti University, Shahid Shahryari SQ, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2017-10-07, 1396/07/15
Ethics committee reference number
SBU.ICBS 96/1020
Health conditions studied
1
Description of health condition studied
Autistic disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
QEEG
Timepoint
Before the intervention, after the intervention and two months after the intervention
Method of measurement
EEG device with 32 channels
2
Description
Executive functions
Timepoint
Before the intervention, after the intervention and two months after the intervention
Method of measurement
The standard BRIEF executive function assessment questionnaire
3
Description
Autism Sign
Timepoint
Before the intervention, after the intervention and two months after the intervention
Method of measurement
CARS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
The emotional richment intervention program has three levels:
o First level: Connect with the child emotionally and build emotionally band
o Second Level: parent-child interaction
o Third level: child-parent interaction
Category
Lifestyle
2
Description
Control Group:
Remove Digital Devaices
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ava autism center
Full name of responsible person
Hamid Reza Pouretemad
Street address
No. 2, Deadlock. 4, Seventh Avenue, North Amir Abad
City
Tehran
Province
Tehran
Postal code
1984845497
Phone
+98 21 8863 3715
Email
iran3240@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran National Science Foundation
Full name of responsible person
Nosratollah Zargham
Street address
No. 33, Fifth street, North Amir Abad
City
Tehran
Province
Tehran
Postal code
1439634665
Phone
+98 21 8216 1173
Email
pr@insf.org
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran National Science Foundation
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
The Shahid Beheshti University
Full name of responsible person
Hamid Reza Pouretemad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Institute for Cognitive & Brain Sciences, Shahid Beheshti University, Chamran High Way, Daneshjo Blvod, Shahid Beheshti University, Shahid Shahryari SQ, Chamran Higway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990
Fax
Email
pr.office@mail.sbu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
The Shahid Beheshti University
Full name of responsible person
Saeid Sadeghi
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Institute for Cognitive & Brain Sciences, Shahid Beheshti University, Shahid Shahryari SQ, Chamran High Way
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1617
Fax
Email
saeidsadeghi.psychologist@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The Shahid Beheshti University
Full name of responsible person
Saeid Sadeghi
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Institute for Cognitive & Brain Sciences, Shahid Beheshti University, Shahid Sharyari SQ, Chamran High Way
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1617
Fax
Email
saeidsadeghi.psychologist@gmail.com
Web page address
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
Behavioral 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
Behavioral 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
Saeid Sadeghi
Mobile number: 0098 9120132485
Phone number: 0098 21 22431617
Email: saeidsadeghi.psychologist@gmail.com
Address: Institute for Cognitive & Brain Sciences, Shahid Beheshti University, Shahid Shahryari SQ, Chamran Highway
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.