Evaluation of the effect of sensory integration approach on stereotyped behaviors of children with autism spectrum disorder

Determining the effectiveness of the sensory integration approach in reducing stereotypical behaviors in children with autism spectrum disorder

A concealed, randomized, double-blind, parallel group clinical trial with 60 participants randomly assigned into two equal groups. Randomization was performed using the Rand function in Microsoft Excel.

The study is conducted at special education centers for children with autism spectrum disorder in Ahvaz. The intervention includes 11 face-to-face sensory integration sessions delivered by an occupational therapist. Effectiveness is evaluated using questionnaire results completed by the teacher, and participants are followed throughout the study.

Inclusion Criteria: Diagnosis of autism spectrum disorder with mild to moderate severity; age between 4 to 10 years; enrollment in special education centers for children with autism spectrum disorder in Ahvaz city; willingness and consent of parents to participate in the study; regular use of Risperidone and Ritalin medications as reported by parents. Exclusion Criteria: Concurrent diagnosis of severe psychiatric disorders such as psychosis, severe bipolar disorder, personality disorder, or uncontrolled epilepsy; diagnosis of blindness or deafness.

In the intervention group, children receive a sensory integration therapy program consisting of targeted sensory-motor activities aimed at improving sensory processing and reducing stereotypical behaviors. The control group receives standard care without any specific intervention. Both groups are followed concurrently throughout the study.

Change in the severity of stereotypical behaviors in children with autism spectrum disorder, based on the results of the Garth questionnaire.

To allocate 60 participants into two groups of 30 each, a randomization method using blocks of 4 was employed. In this method, each block consisted of 4 individuals, evenly divided between the two groups (two participants in the intervention group and two in the control group). First, all possible combinations of this type of allocation (such as AABB, ABAB, ABBA, etc.) were entered into Excel software. Then, 15 blocks were randomly selected from these combinations so that a total of 60 participants were evenly and randomly assigned to the two groups. To generate random combinations, the Rand Between and Index functions in Excel were used, determining each individual's placement in the intervention or control group. Finally, the results were manually saved to ensure no changes occurred in the allocation after determination.

De-identified individual participant data, including results for the primary outcome measure (GARS questionnaire scores), will be available upon reasonable request from qualified researchers after completion of data analysis. Other raw data will be shared only in aggregate form without any possibility of identifying participants.

Access to de-identified individual participant data will be available starting 6 months after publication of the study results and will remain open for 3 years. Access will be granted only to qualified researchers upon submission of a reasonable request and approval by the principal investigator

Data and study documents will be available only to qualified researchers affiliated with accredited academic institutions or recognized research centers, upon submission of a written request and approval by the principal investigator

Access to anonymized data and study documents will be granted only to researchers affiliated with academic and scientific institutions. Requestors must submit a formal application describing the intended analyses. Use of the data and documents is limited to approved research purposes, and any further sharing or publication requires prior permission from the study’s principal investigator. Compliance with ethical guidelines and confidentiality agreements is mandatory

Applicants requesting study documents or data can submit their written requests via email to the principal investigator. If postal correspondence is required, they may contact the following postal address at Jundishapur University of Medical Sciences, Ahvaz. Contact details are as follows: Contact Person: Dr. Hossein Kemili Sani Email: hossein.kemili@ajums.ac.ir Postal Address: Golestan Street, Jundishapur University of Medical Sciences, Ahvaz, Postal Code 61357-14551, Iran Phone Number: +98 61 3333 1234 Fax Number: +98 61 3333 5678 Priority for receiving requests is via email, and if official documents or formal correspondence are needed, they will be handled through the postal address.

Applicants must submit a written request via email or postal mail to the study coordinator. Upon receipt, the request will undergo an initial review by the research team to ensure completeness and validity. Then, the request will be forwarded to the ethics committee and relevant authorities for approval. This process typically takes 2 to 4 weeks. Once approved, de-identified documents or data files will be sent to the applicant electronically. If printed copies or official documents are required, additional time will be needed depending on the delivery method