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IRCT20221224056907N1 IRCT 2023-01-31 University of social welfare and rehabilitation sciences Effect of virtual reality games in autism spectrum disorder (ASD) The comparison between the effectiveness of using virtual reality games and conventional intervention on social-communication skills of school-aged children with autism spectrum disorder 2023-02-24 anticipated 32 Complete https://irct.ir/trial/67577 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The blocked randomization method is used to allocate participants to two groups. This allocation is done in several step. First, using the online software application provided by sealedenvelope.com, a random sequence is generated with blocks of four. Then, to hide the random allocation, sequentially numbered, opaque sealed envelopes (SNOSE) are used in a random sequence. Based on the sample size, 32 envelopes with aluminum foil inside (to prevent ''hot lighting'') are prepared. Each entity in the random sequence is noted on a card and is replaced in the envelope in numbered envelope. Finally, the envelopes are sealed and placed in boxes, respectively. At the time of registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes is opened respectively and so the participant's assigned group is revealed. In this approach, the experts who check the inclusion and exclusion criteria and the experts who do the allocation process are independent, Blinding description: The study is double-blind and participants and assessors will be blinded to randomized group allocation. Children in the intervention group will receive joint attention tasks through virtual reality (VR) games with VR glasses, while children in the control group will use VR glasses only to watch a simple animation. Furthermore, both groups receive the conventional speech and language therapy during the experiment. The assessors are also not aware of which intervention participants have received and whether the assessments are pre- or post intervention. N/A Autism spectrum disorder. Intervention 1: Intervention group: Virtual reality games in order to make improvement joint attention through VR glasses, 15 sessions with an interval of 48 hours, three sessions per week, each session includes one or two virtual reality games, and the duration of each game is about five minutes. There is a three to five minute break between each game. Intervention 2: Control group: A simple animation through VR glasses, 15 sessions with an interval of 48 hours, three sessions per week, each session includes one or two animations with virtual reality characters, and the duration of each animation is about five minutes. There is a three to five minute break between each animation. Yes - There is a plan to make this available What will be shared: The results of this study will be published in peer-reviewed journals. When: After publishing results To whom: Academic researchers Conditions: Data will be available only for research purpose. Where to obtain: Through sending an email to: hassanyazdanian@gmail.com How to obtain: The requested data will be sent as soon as possible after receiving the email. Comments:
public Hassan Yazdanian
Unit 6, No. 25, Qods St., Eneghelab Ave., Tehran
Tehran Iran (Islamic Republic of) 1417743157 +98 21 8612 6317 hassanyazdanian@gmail.com Tose'e Darman Sarv scientific Talieh Zarifian
Speech Therapy Department, University of Social Welfare and Rehabilitation Sciences, Koudakyar Ave. Tehran, Iran
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0139 ta.zarifian@uswr.ac.ir University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Monolingual in Persian Parents consent for inclusion in the experiment A clinical diagnosis of autism spectrum disorder (ASD) 7 years 11 years Both History of problems with virtual reality games History of seizures, epilepsy, migraines, vertigo, psychosis, or photophobia Obvious vision or hearing problem Severe stereotyped behaviors and hyperactivity Severe sensory or balance impairments Inability to understand and follow simple instructions Lack of proper psychomotor development F84.0 Autistic disorder Rehabilitation Rehabilitation Intervention group: Virtual reality games in order to make improvement joint attention through VR glasses, 15 sessions with an interval of 48 hours, three sessions per week, each session includes one or two virtual reality games, and the duration of each game is about five minutes. There is a three to five minute break between each game. Control group: A simple animation through VR glasses, 15 sessions with an interval of 48 hours, three sessions per week, each session includes one or two animations with virtual reality characters, and the duration of each animation is about five minutes. There is a three to five minute break between each animation. Joint attention skills. Timepoint: Assessment of joint attention skills at the beginning of the study (baseline, before the start of the intervention), at the end of the study and one month after the end of the study (follow-up). Method of measurement: Floreo questionnaire; pre- and post-assessment game. Social-communication skills. Timepoint: Assessment of joint attention skills at the beginning of the study (baseline, before the start of the intervention), at the end of the study and one month after the end of the study (follow-up). Method of measurement: Autism Classification System of Functioning: Social Communication (ACSF: SC). University of social welfare and rehabilitation sciences Approved 2022-12-21 Research Ethics Committees of University of Social Welfare and Rehabilitation Sciences Kodakyar Ave., Daneshjo Blvd., Evin, Tehran Tehran Tehran Iran (Islamic Republic of)