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IRCT20180707040370N8 IRCT 2020-07-30 Hamedan University of Medical Sciences Exploring the effect of extended-reality training contents on basic recognition deficits in children with Autism Spectrum Disorder 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 2020-09-21 anticipated 32 Complete https://irct.ir/trial/49837 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Childhood Autism. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: A portion of the information, such as information on the main outcome or the like, can be shared. When: 6 months after publishing the results To whom: Researchers working in academia Conditions: Data analysis is permitted with the author's permission. Where to obtain: Hamadan University of Medical Sciences How to obtain: Requests should be submitted to the corresponding author via email. He will follow up with the inquiry Comments:
public Zohreh Salimi
No.1, Noshad Building, Danesh4, Meraj St., Mohamadie Boulevard,
Hamedan Iran (Islamic Republic of) 6515997597 +98 81 3272 7805 salimizohreh@gmail.com Hamedan University of Medical Sciences scientific Zohreh Salimi
No.1, Noshad Building, Danesh4, Meraj St., Mohamadie Boulevard,
Hamedan Iran (Islamic Republic of) 6515997597 +98 81 3272 7805 salimizohreh@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) 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 4 months 10 years Both 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 F84.0 Autistic disorder Rehabilitation Rehabilitation 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. 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. 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. 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. Center for International Science and Technology Cooperation Hamedan University of Medical Sciences Center for International Science and Technology Cooperation Approved 2020-07-10 Ethics Committee of Hamadan University of Medical Sciences Hamadan University of Medical Sciences, Fahmiheh Street, Hamadan Hamedan Hamadan Iran (Islamic Republic of)