The effect of the "cognitive orientation to daily occupational performance" (CO-OP) approach on occupational and motor performances in 7-12 year old children with Autism spectrum disorder

Determining the effect of the "cognitive orientation to daily occupational performance" (CO-OP) approach on occupational and motor performances performances in children with Autism spectrum disorder (ASD).

Clinical trial with control group, parallel groups, double-blind, randomized with SPSS software, on 30 patients.

Occupational Therapy Clinic - Autism Special Schools

In this study, the main inclusion criteria include children aged 7 to 12 years with a diagnosis of high-functioning ASD, the ability to communicate verbally in Persian. The main exclusion criteria include children with intellectual disabilities or progressive neurological disorders, children whose parents do not cooperate or withdraw from the study, and children who are unable to complete interventions or assessments for medical reasons.

This study will be a clinical trial and will include two intervention and control groups: 1. Control group: Children in this group will receive routine occupational therapy treatment at the center, which will be assessed in two sessions (pre-test and post-test) with research tools. Routine treatment in this study refers to a set of common occupational therapy interventions that are typically provided in rehabilitation centers for children with ASD. 2. Intervention group: Children in this group will receive routine treatment along with a CO-OP-based intervention. This intervention is designed based on the standard protocol developed by Polatajko et al. and is structured and based on cognitive learning. The CO-OP-based intervention is designed as a structured 12-session protocol (45-60 minute sessions) in children aged 7 to 12 years. The sessions will be held 2 days a week.

Occupational performance; Performance satisfaction; Motor skills

After meeting the entry requirements, obtaining written informed consent, and completing a pre-test assessment, participants will be randomly assigned to two intervention and control groups with a 1:1 allocation ratio. In this study, a block randomization method with variable block sizes will be used to maintain a balance in the number of samples in the two groups and reduce the predictability of the allocation sequence. The randomization unit will be individual, and the random sequence will be generated using SPSS version 25 software by a member of the research team who has no role in implementing the intervention and evaluating the outcomes. In order to reduce allocation bias, allocation concealment will be performed sequentially through the use of opaque, sealed, numbered, and sealed envelopes, such that after completing the baseline assessment of each participant, the relevant envelope will be opened and his or her group will be determined. The outcome assessor will be blind to the group allocation of the participants and will not interfere in the randomization and intervention allocation process.

In this study, pre-test and post-test assessments are conducted by an independent, blinded evaluator who has no knowledge of the children's allocation to the intervention or control group. The principal investigator is also blinded to the children's grouping during data collection. The occupational therapist conducting the intervention sessions is aware of the CO-OP method for operational purposes, but is not responsible for data evaluation. Due to the nature of the CO-OP-based occupational therapy intervention, blinding of participants was not possible. The staff of the treatment centers and schools also have only the necessary information for operational support and are blinded to the group allocation. This design reduces assessment bias and increases the validity of the study results.

Individual participant data (IPD) and related study documents from the clinical trial on occupational therapy in children with Autism Spectrum Disorder. The dataset includes de-identified participant-level information for all study variables, including primary outcomes (occupational performance, satisfaction with performance, motor skills) and relevant demographic characteristics. All personal identifiers have been removed to ensure confidentiality. The shared documents also include the study protocol, statistical analysis plan, and informed consent forms

Individual participant data and study-related documentation will be available for sharing for six months after the publication of the main study results. The access period will be from 1405 AH after the access start date.

Access to the individual participant data and related study documents will be granted only to researchers affiliated with academic or scientific institutions who submit a reasonable request. Researchers from industry may also request access if their proposed analysis aligns with the scientific objectives of the study and is approved by the study steering committee.

The provided data and documents are intended solely for research and scientific purposes by academic researchers and investigators affiliated with scientific institutions. Any secondary analysis of the data must ensure participant confidentiality, with all identifying information removed. Commercial use or publication of the data without written permission from the research team is prohibited. Requesting researchers must specify the purpose and type of analysis in their application, and access will be granted upon approval by the research team.

To receive the study data and documents, applicants can send their request via email to the principal investigator, "Dr. Seifollah Jahantabi-nejad", at the email address "jahantabi-s@ajums.ac.ir". If necessary, it is also possible to send a postal correspondence to the address "Khuzestan-Ahvaz-Golestan-Ahvaz Jundishapur University of Medical Sciences-Faculty of Rehabilitation Sciences". After being reviewed and approved by the research team, the requests will be submitted to the applicant within a specified period of time.

The applicant must first submit a written or emailed request to the principal investigator, including the purpose of data use and research details. The research team will review the request and, if the documentation is complete and ethical and privacy requirements are met, approve it. After approval, de-identified data or documents will be provided to the applicant in electronic or printed format. The review and provision process is usually completed within 2 to 4 weeks after receiving a complete request.