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IRCT20210507051213N1 IRCT 2021-07-07 Iran University of Medical Sciences The comparison of the effectiveness of Enhanced Milieu Teaching (EMT) delivered in face-to- face and telepractice formats on improving communication skills of children with Autism spectrum disorder The comparison of the effectiveness of Enhanced Milieu Teaching (EMT) delivered in face-to- face and telepractice formats on improving communication skills of children with Autism spectrum disorder 2021-06-05 anticipated 20 Complete https://irct.ir/trial/56305 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We use an online random number sequence generator (random.org; Haahr, 2010) to randomly allocate participants to intervention group (receiving online EMT) or control group (receiving face-to- face EMT). Haahr M. (2010). Random.org: True Random Number Service. Available at: http://www.random.org (accessed July 3, 2021), Blinding description: In this study, assessors evaluate the clients before, during, and after follow-up, without knowing which treatment group each child is assigned to. Evaluators are not among the researchers in this study. N/A Autism Spectrum Disorder. Intervention 1: Arranging the environment: Providing online parent training to structure the child's daily routine in order to form routines, limiting the environment, waiting for the child to ask for help, giving the child what he/she needs, and talking about the object's features. Intervention 2: Play and participation: Providing online parent training to choose interesting and fun toys, to join the child through active play with toys of his/her choice, and to teach activities and stages of the target play level to the child. Intervention 3: Intervention group: Attention and responsiveness: Providing online parent training to sit face to face with the child, to follow the child's inner driver and to respond to all the child's communication. Intervention 4: Intervention group: imitating and modeling: Providing online parent training to imitate the child's non-verbal activities and to provide language modeling through verbal description of the child's activities. Intervention 5: Control group: Arranging the environment: Providing in-person parent training to structure the child's daily routine in order to form routines, limiting the environment, waiting for the child to ask for help, giving the child what he/she needs, and talking about the object's features. Intervention 6: Control group: Providing in-person parent training to choose interesting and fun toys, to join the child through active play with toys of his/her choice, and to teach activities and stages of the target play level to the child. Intervention 7: Control group: Attention and responsiveness: Providing in-person parent training to sit face to face with the child, to follow the child's inner driver and to respond to all the child's communication. Intervention 8: Control group: Intervention group: imitating and modeling: Providing in-person parent training to imitate the child's non-verbal activities and to provide language modeling through verbal description of the child's activities. Yes - There is a plan to make this available What will be shared: Individual Participant Data (IPD) Study protocol Statistical analysis map Informed consent form Clinical study report When: Documentation will be available 3 months after the results are published. To whom: Academic Researchers Speech Therapists Conditions: Data, analyzes, clinical study reports and treatment protocols for academic studies Therapeutic protocol for use in clinical work Where to obtain: Salman Abdi Iran School of Rehabilitation Sciences salmanabdi.slp@gmail.com 09013213415 How to obtain: Electronic correspondence or telephone call with the researcher, providing reasons for accessing the data or protocol Comments:
public Salman Abdi
DolatAbad, Abu Saeed Street 24 meters, Abu Saeed 39, No. 28
Karaj Iran (Islamic Republic of) 3136776558 +98 26 3270 8659 salmanabdi.slp@gmail.com Iran University of Medical Sciences scientific Leila Ghelichi
Maddakaran Alley, Shah Nazari St., Madar Square, Mirdamad Blvd., Tehran
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 7124 lghelichi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Having definitive diagnosis of autism based on the psychiatrist's clinical judgment and the Gilliam Autism Diagnostic Scale - Second Edition (Garz-2). Being 3–6 years old. Having verbal imitation skill . Having less than a hundred functional words. 3 years 6 years Both Having neurological problems such as cerebral palsy, seizures, and brain injuries that are identified through observation, examination as well as the use of the child's history and medical records. Having sensory problems such as obvious hearing loss or visual impairment that cannot be compensated by assistive devices. Being Bilingual. F84.0 Autistic disorder Rehabilitation Rehabilitation Rehabilitation Rehabilitation Rehabilitation Rehabilitation Rehabilitation Rehabilitation Arranging the environment: Providing online parent training to structure the child's daily routine in order to form routines, limiting the environment, waiting for the child to ask for help, giving the child what he/she needs, and talking about the object's features. Play and participation: Providing online parent training to choose interesting and fun toys, to join the child through active play with toys of his/her choice, and to teach activities and stages of the target play level to the child Intervention group: Attention and responsiveness: Providing online parent training to sit face to face with the child, to follow the child's inner driver and to respond to all the child's communication Intervention group: imitating and modeling: Providing online parent training to imitate the child's non-verbal activities and to provide language modeling through verbal description of the child's activities Control group: Arranging the environment: Providing in-person parent training to structure the child's daily routine in order to form routines, limiting the environment, waiting for the child to ask for help, giving the child what he/she needs, and talking about the object's features. Control group: Providing in-person parent training to choose interesting and fun toys, to join the child through active play with toys of his/her choice, and to teach activities and stages of the target play level to the child Control group: Attention and responsiveness: Providing in-person parent training to sit face to face with the child, to follow the child's inner driver and to respond to all the child's communication Control group: Intervention group: imitating and modeling: Providing in-person parent training to imitate the child's non-verbal activities and to provide language modeling through verbal description of the child's activities Children's communication skills including communication intentions, frequency of communication, means of communication, non-verbal communication, mean length of utterance, expressive and receptive vocabulary. Timepoint: Evaluation of communication variables before the intervention, after the intervention and two months after the intervention (the follow-up stage). Method of measurement: Structured observation and MacArthur-Bates Communicative Development Inventories. Iran University of Medical Sciences Approved 2021-03-15 Ethics Committee of Iran University of Medical Sciences Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)