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IRCT20211114053055N1 IRCT 2022-02-02 Tehran University of Medical Sciences Effectiveness of family centered play-based interventions on sensory pattern and occupational performance of children with autism spectrum disorder Effectiveness of family centered play-based interventions on sensory pattern and occupational performance of children with autism spectrum disorder 2022-02-20 anticipated 48 Complete https://irct.ir/trial/59962 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: We will have envelopes A and B for the number of people we have in the study (48). Each of the eligible participants will enter the intervention group by selecting envelope A and the control group by selecting envelope B, Blinding description: Eligible families are given the necessary explanations about the study and are assured that their information will be kept with the study team. Participants' families will be explained that assessments will be performed for their child, and they may then be taught games to play at home, reassuring them that there will be no harm or danger to any of them. The study process will not be relevant to their child. N/A Autism Spectrum Disorder. Intervention 1: Intervention group: the researcher teaches the parents how to play the selected games that are in accordance with the evaluations performed and the reported sensory pattern of the child, along with the necessary considerations in accordance with the conditions and sensory needs of the child to play at home in the presence of the child. This training will be in person and with visual instructions and written explanations for home implementation. It should be emphasized that the presence of the child in weekly training sessions and troubleshooting is mandatory, and although in addition to meeting sensory needs, strengthening mutual attention and engaging children is one of the primary goals of all selected games, but corrections and adaptations to conditions and environment The game is tailored to the needs of each child in order to play the games more correctly and completely at home and the cooperation of as many children as possible is suggested to the parents by the researcher. Parents are then asked to play games at home. The duration of the intervention is 3 days a week for 8 weeks. During the week, the researcher communicates with the family by phone or video and follows the process of how the games are played at home and gives feedback to the family. The accuracy of the games will be measured by the parents through a checklist prepared by the researcher in consultation with the research team. The games will be selected from the book of early intervention games written by Ms. Barbara Sher. Intervention 2: Control group: During the intervention, the control group will receive their other rehabilitation programs (including speech therapy, etc.) according to the previous procedure. The primary and secondary evaluations of this study will be performed for them as well. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Parvin Raji
Department of Occupational Therapy, Tehran University of Medical Sciences, Corner of Safi Alisha, Above Pich Shemiran, Enghelab St.
Tehran Iran (Islamic Republic of) 1148965111 009877538798 praji@tums.ac.ir Tehran University of Medical Sciences scientific Parvin Raji
Department of Occupational Therapy, Tehran University of Medical Sciences, Corner of Safi Alisha, Above Pich Shemiran, Enghelab St.
Tehran Iran (Islamic Republic of) 1148965111 009877538798 praji@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Children with autism spectrum disorder at the age of 3 to 6 years Existence of sensory processing disorder No history of seizures or epilepsy No accompanying physical problems GARS score below 80 (Autism level 1 and 2) Parents of children must have at least a diploma level of education. 3 years 6 years Both Lack of parents or child cooperation at any stage of the study F84.0 Autistic disorder Rehabilitation Rehabilitation Intervention group: the researcher teaches the parents how to play the selected games that are in accordance with the evaluations performed and the reported sensory pattern of the child, along with the necessary considerations in accordance with the conditions and sensory needs of the child to play at home in the presence of the child. This training will be in person and with visual instructions and written explanations for home implementation. It should be emphasized that the presence of the child in weekly training sessions and troubleshooting is mandatory, and although in addition to meeting sensory needs, strengthening mutual attention and engaging children is one of the primary goals of all selected games, but corrections and adaptations to conditions and environment The game is tailored to the needs of each child in order to play the games more correctly and completely at home and the cooperation of as many children as possible is suggested to the parents by the researcher. Parents are then asked to play games at home. The duration of the intervention is 3 days a week for 8 weeks. During the week, the researcher communicates with the family by phone or video and follows the process of how the games are played at home and gives feedback to the family. The accuracy of the games will be measured by the parents through a checklist prepared by the researcher in consultation with the research team. The games will be selected from the book of early intervention games written by Ms. Barbara Sher. Control group: During the intervention, the control group will receive their other rehabilitation programs (including speech therapy, etc.) according to the previous procedure. The primary and secondary evaluations of this study will be performed for them as well. Occupational performance. Timepoint: After two months and after the end of the intervention. Method of measurement: Canadian Occupational Performance Measure. Sensory processing. Timepoint: After two months and after the end of the intervention. Method of measurement: Canadian Occupational Performance Measure. Tehran University of Medical Sciences Approved 2021-12-05 Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o Department of Occupational Therapy, Tehran University of Medical Sciences, Corner of Safi Alisha, Above Pich Shemiran, Enghelab St. TEHRAN Tehran Iran (Islamic Republic of)