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

Comparing the effectiveness of joint attention interventions by virtual reality games and conventional treatment on the improvement of social-communication skills of children with autism

Two arm, parallel group, double blind, randomized, sham controlled clinical trial of 32 participants. Randomization was computerized with concealed randomization sequence carried out by www.sealedenvelope.com.

Eligible participants will be recruited selected from autism schools in Tehran City, Iran, using a convenience sampling method. The participants will randomly assign to the target and control groups. The study is double-blind and participants and assessors will be blinded to randomized group allocation. Both groups will receive the intervention in the speech and language therapy rooms of the schools. VR Sessions will occur 3 days per week, with at least 48 h between sessions. A total of 15 VR sessions are completed over a 5-week period. A follow-up appointment at the assessment site will be approximately one month after the end of intervention.

Inclusion criteria: A clinical diagnosis of autism spectrum disorder (ASD) Exclusion criteria: Inability to understand and follow simple instructions; History of seizures, epilepsy, migraines, vertigo, psychosis, or photophobia

Children in the intervention group will receive joint attention interventions 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 conventional speech and language therapy during the experiment.

social communication; initiating joint attention; responding to joint attention; Visual pursuit; Eye contact

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.

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.

The results of this study will be published in peer-reviewed journals.

After publishing results

Academic researchers

Data will be available only for research purpose.

Through sending an email to: hassanyazdanian@gmail.com

The requested data will be sent as soon as possible after receiving the email.