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IRCT20240305061172N1 IRCT 2024-04-08 Mashhad University of Medical Sciences Investigating the effectiveness of training of the theory of mind in improving the social interactions of children with autism spectrum disorder level 1 Investigating the effectiveness of remote training of the theory of mind in improving the social interactions of children with autism spectrum disorder level 1 compared to face-to-face training 2024-04-20 anticipated 34 Complete https://irct.ir/trial/75858 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: According to the nature of the study, blinding is not possible. However, the evaluator and statistician will not know about the allocation of the subjects, Randomization description: Due to the necessity of equal number of participants in two study groups, randomization will be done based on the blocked randomization method. For this, using the Randomization menu of the website of https://www.sealedenvelope.com (which provides researchers with a web-based block randomization tool) and considering random blocks of 2, 4 and 6 participants, the allocation of subjects to groups will be determined. For allocation concealment, Sequentially numbered, sealed, opaque envelopes (SNOSE) will be used. N/A Autism spectrum disorders. Intervention 1: Intervention group: distance learning (online): Participants will be trained in mind reading concepts in 10 treatment levels for 20 sessions in 10 weeks based on a reliable source (Havlin et al., 1999; translated by Rezaei, 2019). (Number of sessions per week: 2 - Duration of each session: 20 minutes - Session audience: child + mother - Executive measures in each session: 1. Teaching exercises to the mother to guide the child in the online session and perform at home (daily for at least 45 minutes)2. Examining the video of the exercises and the mother's report on the exercises and the child's conditions at home3. Answering the mother's questions - mandatory items of each session: Mother's verbal report and at least 3 videos of 40-60 seconds (one of the best, one of the worst, and one of the usual) of performing exercises at home. Intervention 2: control group: face-to-face training (traditional method): Participants will be trained in mind reading concepts in 10 treatment levels for 20 sessions in 10 weeks based on a reliable source (Havlin et al., 1999; translated by Rezaei, 2019). (number of sessions per week: 1 - duration of each session: 40 minutes - session audience: mother + child - implementation measures in each session: 1. Performing exercises with the child2. Providing explanations of the exercises to the mother to perform at home3. Examining the mother's verbal report of the child's activity in the interval between sessions4. Answering mother's questions - the mandatory items of each session: Mother's verbal report of performing exercises at home. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Fatemeh Haresabadi
Department of Speech Therapy,Kharazmi building, university campus, Vakilabad Blvd, Bahonar Blvd, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177949025 +98 51 3189 2001 haresabadif@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Haresabadi
Department of Speech Therapy,Kharazmi building, university campus, Vakilabad Blvd, Bahonar Blvd, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177949025 +98 51 3189 2001 haresabadif@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Receiving a diagnosis of Autism Spectrum Disorder, level 1 by a psychiatrist Being within the autistic range according to the GARS-3 questionnaire Monolingual Persian speaker The age of children should be between 6 and 9 years old no presence of any intellectual, auditory, visual, or other neurocognitive problems except ASD, as determined through observation and reviewing files at centers, as well as interviews with parents 6 years 9 years Both Parents' lack of consent for their child's participation in the study Observing the signs of parents' inability to participate in exercises and perform them at home F84.0 Autistic disorder Rehabilitation Rehabilitation Intervention group: distance learning (online): Participants will be trained in mind reading concepts in 10 treatment levels for 20 sessions in 10 weeks based on a reliable source (Havlin et al., 1999; translated by Rezaei, 2019). (Number of sessions per week: 2 - Duration of each session: 20 minutes - Session audience: child + mother - Executive measures in each session: 1. Teaching exercises to the mother to guide the child in the online session and perform at home (daily for at least 45 minutes)2. Examining the video of the exercises and the mother's report on the exercises and the child's conditions at home3. Answering the mother's questions - mandatory items of each session: Mother's verbal report and at least 3 videos of 40-60 seconds (one of the best, one of the worst, and one of the usual) of performing exercises at home. control group: face-to-face training (traditional method): Participants will be trained in mind reading concepts in 10 treatment levels for 20 sessions in 10 weeks based on a reliable source (Havlin et al., 1999; translated by Rezaei, 2019). (number of sessions per week: 1 - duration of each session: 40 minutes - session audience: mother + child - implementation measures in each session: 1. Performing exercises with the child2. Providing explanations of the exercises to the mother to perform at home3. Examining the mother's verbal report of the child's activity in the interval between sessions4. Answering mother's questions - the mandatory items of each session: Mother's verbal report of performing exercises at home The score of an autistic child on the Sternberg Theory of Mind Test. Timepoint: Evaluation before and after the intervention. Method of measurement: Theory of Mind Test - Sternmen. The score of an autistic child on the Garshasebi and Elliot (1990) Social Skills Questionnaire. Timepoint: Evaluation before and after the intervention. Method of measurement: The Garshasebi and Elliot (1990) Social Skills Questionnaire. The score of an autistic child on the Communication Skills Checklist - Second Edition. Timepoint: Evaluation before and after the intervention. Method of measurement: The Communication Skills Checklist - Second Edition. The assessment of informal social interaction behaviors. Timepoint: Evaluation before and after the intervention. Method of measurement: The assessment of informal social interaction behaviors. Mashhad University of Medical Sciences Approved 2024-03-11 Ethics committee of Mashhad University of Medical Sciences Speech therapy department, 2nd floor, Shahid Kharazmi educational building, University campus, Vakil Abad Blvd., Bahnar Blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)