Exploring the effect of extended reality training contents versus traditional methods such as flash cards, on basic recognition deficits in children with Autism Spectrum Disorder: A single-blinded randomized controlled trial
Exploring the effect of extended reality training contents versus traditional methods such as flash cards, on basic recognition deficits in children with Autism Spectrum Disorder
Design
Single-blinded randomized controlled trial with two parallel groups: one intervention group and one control group, and 32 participants
Settings and conduct
Children will receive extended-reality-based or flashcard-based training twice a week for 10 weeks at Sedighe-Mansour Autism Center in Hamedan, Iran
Participants/Inclusion and exclusion criteria
4 to 10 years old children with Autism Spectrum Disorder, level 2
Intervention groups
The intervention group will receive 20 sessions of half-hour training with extended reality goggles over 10 weeks, while the control group receives the same amount of training with standard-of-care methods such as flash cards.
Main outcome variables
Test grade in pre and post tests; eye contact
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180707040370N8
Registration date:2020-07-30, 1399/05/09
Registration timing:prospective
Last update:2020-07-30, 1399/05/09
Update count:0
Registration date
2020-07-30, 1399/05/09
Registrant information
Name
Ensiyeh Jenabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0496
Email address
e.jenabi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-21, 1399/06/31
Expected recruitment end date
2020-12-19, 1399/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Exploring the effect of extended reality training contents versus traditional methods such as flash cards, on basic recognition deficits in children with Autism Spectrum Disorder: A single-blinded randomized controlled trial
Public title
Exploring the effect of extended-reality training contents on basic recognition deficits in children with Autism Spectrum Disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children 4 to 10 years old with Autism Spectrum Disorder, level 2
Autism disorder should be diagnosed by a pediatric psychologist
Parents consent for inclusion in the experiment
Exclusion criteria:
Sever behavioral or/and communication deficits that prevent understanding of simple explanations of the experiment or inversely effects the child's ability to perform the experiment contents
Age
From 4 months old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
At first, a blind colleague will be given the names of the eligible participants and asked to encode the names and insert all males into one column in a Excel file and all females into one column in another Excel file (bock randomization). Then, using RAND function in Excel, a series of random numbers will be generated next to the unrecognizable encoded names in both files. Finally, when any of the generated random numbers are greater or equal to the mean of all numbers in their own column,"intervention" will be inserted next to them, and if they are lower than the mean, "control" will be inserted. In addition to allocation concealment, this will ensure that both groups have comparable number of males and females and also equal number of participants in general, and are yet totally randomized.
Blinding (investigator's opinion)
Single blinded
Blinding description
A novel experimenter who is unaware of the experiment contents will give the pre and post tests. Also, a novel rater who is unaware of the experiment contents will examine the videos from an early, mid, and late session to find the percentage of making eye contact of each child.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Fahmiheh Street, Hamadan
City
Hamedan
Province
Hamadan
Postal code
6517838678
Approval date
2020-07-10, 1399/04/20
Ethics committee reference number
IR.UMSHA.REC.1399.376
Health conditions studied
1
Description of health condition studied
Childhood Autism
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Test Grade
Timepoint
In a pretest session one week, a few days before starting the intervention, and again in the post-test session after finishing the intervention
Method of measurement
Percentage of correct answers to image recognition tests
Secondary outcomes
1
Description
Eye contact
Timepoint
During sessions 1, 10, and 20 of training
Method of measurement
Ratio of time that participant made eye contact to the duration of session
Intervention groups
1
Description
Intervention group: Children will receive half-hour training twice a week for 10 weeks with Nreal and Oculus Rift S goggles. The content will be engaging 3D basic objects such as animals and children will be encouraged to interact with them and surf around the virtual world. The researcher will guide the child through the training session, introducing the objects to them and asking them questions to make sure they are learning the concepts.
Category
Rehabilitation
2
Description
Control group: Children will receive half-hour training twice a week for 10 weeks with standard-of-care educational materials such as flashcards. The researcher will engage the child via games and reinforcements, making sure that they are learning the concepts, similar to that of the intervention group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sedighe-Mansor Center for Autism
Full name of responsible person
Fateme Malmir
Street address
Besat Sq., Jahad St., Azimi Alley
City
Hamedan
Province
Hamadan
Postal code
6515713373
Phone
+98 81 3821 8164
Email
fetememalmir91@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
S_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Center for International Science and Technology Cooperation