Designing a training program for mindful participation of parents in self-care performance of children with autism spectrum disorder aged 6-12 years based on the Canadian Model of Occupational Performance-Engagement and investigating its effectiveness on children's performance and parents' satisfaction in performing self-care skills

Designing a training program for mindful participation of parents in self-care performance of children with ASD based on the CMOP-E model and investigating its effectiveness on children's performance and parents' satisfaction in performing self-care skills

Randomized, superiority, exploratory, parallel group trial. randomization.com is used for randomization.

Comprehensive Autism Center of Tabriz University of Medical Sciences and the National Autism Association in Tehran, Iran. The outcome assessor will be blinded.

Children: ASD diagnosis at Level 1 or 2 Received rehabilitation services for at least 6 months in the past 2 years Identified at least 3 priorities in COPM related to self-care Ages 6 to 12 years Parents: Proficient in reading and writing DASS score < 13 Standard score < 110 in two MIPQ subscales Willingness and commitment to fully participate in the research Exclusion Criteria: Participation in another mindfulness study Concurrent participation in psychological counseling sessions Responsibilities for the care of a disabled person other than a child with ASD Lack of consent to continue participating in the study

The intervention involves a 9-week program led by an MBSR-trained researcher, integrating general and personalized mindfulness techniques. Participants, randomly assigned to the Mindful Participation Educational Program or control group, receive tailored interventions alongside conventional occupational therapy. The control group specifically receives conventional occupational therapy for self-care.

Child's self-care performance; Parent's satisfaction with child's self-care performance; Parental function in rehabilitation; child's adjustment; parent's self-efficacy; Mindful parenting; Parenting stress

Method of Randomization: The method employed for randomization is a block randomization approach. This entails organizing participants into blocks, each containing an equal number of individuals, to ensure balanced allocation between the two study groups. Unit of Randomization: Individual participants are the primary unit of randomization in this study. Randomization Strata in Stratified Randomization: No stratified randomization is utilized in this study. Participants are randomized without stratification. Tools Used in Randomization: The randomization process is facilitated using the randomization.com website, a validated online tool. This website ensures a precise and unbiased allocation of participants to either the intervention or control group. Building the Random Sequence: The random sequence is generated through the randomization.com website, ensuring the creation of a unique and unpredictable sequence of assignments for participant allocation. Allocation Concealment: Allocation concealment is implemented to maintain the integrity of the randomization process. Sealed envelopes containing the group assignments are utilized, ensuring that the random allocation remains undisclosed until the time of participant enrollment. Independent Randomization: Randomization is performed by an individual independent of the therapeutic interventions and evaluations. This impartial approach minimizes the potential for bias in the allocation process.

Participants: Owing to the didactic nature of the intervention, participants are exposed to the educational component in their respective environments through the providing companies. Acknowledging the inherent difficulty in blinding participants due to the educational context, this intentional approach aligns with the intervention's nature. This consideration is explicitly outlined in the study design. While participant blinding is challenging, the study makes concerted efforts to ensure impartiality in outcome evaluation and data collection, thereby mitigating potential biases. Principal Investigator (Provider of the Studied Intervention): The principal investigator, as the provider of the studied intervention, maintains awareness of the study groups. This transparency is a conscious aspect of the study design, recognizing the pivotal role of the principal investigator in the intervention's administration. Occupational Therapist - Common Occupational Therapy Interventions: The occupational therapist responsible for the common occupational therapy interventions remains intentionally blinded to the study groups. This deliberate blinding strategy is employed to uphold consistency in the delivery of interventions across both groups. Data Collectors: Individuals tasked with data collection during the trial diligently adhere to protocols to maintain objectivity. While participant blinding may not be practically achievable, data collectors ensure their assessments are impartial and comparable across the studied groups. Outcome Evaluators: Professionals conducting outcome evaluations are adept at comparing participants across interventions, fostering an unbiased interpretation of results. This approach is designed to uphold the scientific rigor and credibility of the study's outcome assessments. Authors of the Article: Authors of the paper, while not directly involved in the day-to-day operations of the trial, adhere to established research reporting standards. They employ anonymized data to ensure objectivity in reporting, contributing to the transparency and scholarly integrity of the study findings.

Title of Data/Document: Raw Deidentified Individual Participant Data (IPD) Details: All data is shared after individuals are de-identified.

The deidentified individual participant data (IPD) will become available starting 3 months after publication. The data will remain accessible for a period of two years from the start date.

The deidentified individual participant data (IPD) and accompanying documents will be made available to researchers affiliated with academic institutions, including faculty, students, and researchers. Access is also extended to professionals and therapists working in relevant businesses, fostering inclusivity in data utilization.

Access Criteria: Access to deidentified individual participant data (IPD) and related documents will be granted for the purpose of further analyses relevant to the scope of this study. Researchers intending to access the data should submit a formal request, outlining the specific analyses they plan to conduct. The mechanism for access will involve submitting requests through a designated online platform or contacting the principal investigator directly. Review Process: Requests for access will be reviewed by the principal investigator to ensure alignment with the intended analyses and compliance with ethical standards. Priority will be given to research proposals that contribute meaningfully to the understanding of the studied interventions and outcomes.

The preferred way of communication is via email. Please send your access requests to [sh.saie@yahoo.com]. Contact Information: Email: [sh.saie@yahoo.com] Telephone: [00989146735546] Contact Person: [Shafagh Saei]

Data Access Process: Submission of Access Request: Applicants are required to submit a formal access request via email to [sh.saie@yahoo.com]. The request should include the applicant's name, affiliation, purpose for data use, and specific data/documents requested. Initial Review: Upon receiving the request, an initial review will be conducted to ensure it aligns with the stated purpose and ethical considerations. Applicants will be notified within 4-7 days regarding the acceptance of their request for further processing. Data Sharing Agreement: If the request is accepted, applicants will be provided with a Data Sharing Agreement outlining terms and conditions. The agreement must be reviewed, signed, and returned within 3-5 days. Access to Data/Documents: Once the signed agreement is received, access credentials and instructions for downloading data/documents will be provided. Access will be granted for a specified period as outlined in the agreement. Support and Queries: Throughout the process, applicants can contact [Shafagh Saei] for any clarifications or support needed. Queries related to the data or access process will be addressed within 3 working days. Estimated Timeline: Initial Review: 4-7 days Data Sharing Agreement: 3-5 days Access Granted: 7 days after receiving the signed agreement

It's important to note that the provided timeline is an estimate, and actual duration may vary based on the volume and complexity of requests, as well as the internal processes of our team.