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IRCT20131112015390N10 IRCT 2025-12-31 Oroumia University of Medical Sciences Examining the Effect of Culturally Adapted Play Therapy with Parental Involvement on Children with Autism Comparing the effectiveness of culturally adapted play therapy with parental involvement versus routine care on stereotyped behaviors, communication skills, and social interactions in children with autism spectrum disorder 2021-06-05 anticipated 36 Complete https://irct.ir/trial/87830 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using the simple randomization by drawing method, 20 children were assigned to the control group and 20 children to the intervention group. The names of all participants were written on pieces of paper and placed in a box. Then, the papers were drawn one by one until the desired sample size for the intervention group was reached, and the remaining names in the box were assigned to the control group, Blinding description: The dataset was coded and anonymized by a member of the research team who was not involved in the analysis phase. The groups were replaced with neutral codes (such as A and B), and any variables that could reveal the nature of the intervention or group assignment were removed. The analyst had access only to the coded raw data and the predetermined statistical analysis protocol. Accordingly, without being aware of the study conditions or group assignments, the analyst performed all stages of the analysis, from assessing normality to conducting comparative tests. N/A Stereotyped Behaviors, Communication Skills, and Social Interactions in Children with Autism. Intervention 1: Intervention group: The intervention involved a series of structured, family-centered play therapy sessions aimed at building trust and engagement between the therapist, mother, and child; enhancing eye contact, social interaction, emotional recognition, and communication skills through traditional Iranian games; encouraging active parental involvement; providing feedback on home assignments; and promoting the continuation of playful therapeutic exercises beyond the sessions. Intervention 2: Control group: This group only engaged in their usual recreational activities under parental supervision. Yes - There is a plan to make this available What will be shared: The data of this study include the scores obtained from standardized questionnaires at three stages (pre-test, post-test, and three-month follow-up). Participant information was coded and anonymized by removing all identifying variables (such as name, national ID, or contact details). All quantitative data, after the anonymization process, will be available for sharing upon researchers’ request and with the approval of the Ethics Committee of Urmia University of Medical Sciences. The data will be accessible only for research purposes and in full compliance with confidentiality and privacy protection principles. When: The release and access to the data of this study will begin after the publication of the research results in a reputable scientific journal. The data will remain available to interested researchers for five years after the publication of the article. Requests must be submitted formally, including the research purpose, to the Deputy of Research and Technology of Urmia University of Medical Sciences. Access to the anonymized data will be granted following review and approval by the Ethics Committee. To whom: Only researchers in the field of health and other related fields will be allowed to access the data if approved by the Vice President for Research and Technology and the corresponding author. Conditions: Deidentified data will only be made available to researchers if there are scientific reasons and the need for statistical studies. Where to obtain: Researchers can send their requests, along with the reasons, to the research project manager with the following information: Dr. Naser Parizad Associate Professor of Nursing Address: School of Nursing and Midwifery, Campus of Urmia University of Medical Sciences, 11th Kilometer of Serou Road, Urmia, West Azerbaijan, Iran Emails: nparizad@gmail.com How to obtain: Researchers can get access to the data by providing reasons and guaranteeing citation to the article(s) resulting from the thesis project. They should send an email to the corresponding author of the research project (Dr. Naser Parizad). Email: nparizad@gmail.com Comments:
public Naser Parizad
School of Nursing and Midwifery, Campus of Urmia University of Medical Sciences, 11th Kilometer of Serou Road
Urmia Iran (Islamic Republic of) 5756151818 +98 44 3275 4961 nparizad@gmail.com Oroumia University of Medical Sciences scientific Naser Parizad
School of Nursing and Midwifery, Campus of Urmia University of Medical Sciences, 11th Kilometer of Serou Road
Urmia Iran (Islamic Republic of) 5756151818 +98 44 3275 4961 nparizad@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) School-aged children (7 to 12 years old) diagnosed with Autism Spectrum Disorder (ASD) Children with moderate to severe levels of autism according to the GARS (Gilliam Autism Rating Scale) criteria Parental willingness to participate in the study Previous diagnosis of autism made by a psychiatrist Residents of Urmia city or surrounding towns under Urmia’s jurisdiction Parents with at least a lower secondary education Obtaining informed consent from parents for participation in the study 7 years 12 years Both Children with low levels of autism according to the GARS (Gilliam Autism Rating Scale) criteria Inability of parents to read and write F84.0 Autistic disorder Behavior N/A Intervention group: The intervention involved a series of structured, family-centered play therapy sessions aimed at building trust and engagement between the therapist, mother, and child; enhancing eye contact, social interaction, emotional recognition, and communication skills through traditional Iranian games; encouraging active parental involvement; providing feedback on home assignments; and promoting the continuation of playful therapeutic exercises beyond the sessions. Control group: This group only engaged in their usual recreational activities under parental supervision. Stereotyped behaviors score. Timepoint: before the start of the intervention, immediately after the intervention, and three months after the intervention. Method of measurement: Gilliam Autism Rating Scale. Social interactions score. Timepoint: Before the start of the intervention, immediately after the intervention, and three months after the intervention. Method of measurement: Gilliam Autism Rating Scale. Communication skills score. Timepoint: Before the start of the intervention, immediately after the intervention, and three months after the intervention. Method of measurement: Gilliam Autism Rating Scale. Oroumia University of Medical Sciences Approved 2021-03-07 Ethics committee of Urmia University of Medical Sciences Orjans Suburb, Resalat Blvd. Urmia West Azarbaijan Iran (Islamic Republic of)