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

Determining the effect of culturally adapted play therapy with parental involvement on stereotyped behaviors, communication skills, and social interactions in school-aged children with autism

A quasi-experimental study, with a pretest-posttest control group design, parallel groups, single-blind, and randomized, conducted on 40 patients. Randomization was performed using a simple random drawing method.

Study setting: Urmia Autism Association. Study population: Children with autism. Blinding: Single-blind. Blinding procedure: The data analyst was blinded to the group allocation (intervention or control) and the actual identity of the participants.

Inclusion Criteria: Children aged 7 to 12 years with Autism Spectrum Disorder (low according to GARS criteria); with a prior psychiatric diagnosis of autism, residing in Urmia or nearby cities; parents with at least a lower secondary education and willingness to participate; no counseling services received during the study; and informed parental consent. Exclusion Criteria: Children aged 7 to 12 years with Autism Spectrum Disorder (moderate to severe according to GARS criteria); Inability of parents to read and write.

Intervention group: The culturally adapted play therapy group. In this group, in addition to routine care, a family-centered culturally adapted play therapy intervention was conducted in 6 sessions of 2 hours each (on average, three sessions per week). Control group: The routine care group. In this group, only the standard care provided by the Autism Association was administered.

Stereotyped behaviors; communication skills; and social interactions.

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.

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.

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.

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.

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.

Deidentified data will only be made available to researchers if there are scientific reasons and the need for statistical studies.

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

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