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IRCT20230628058613N1 IRCT 2023-10-06 University of social welfare and rehabilitation sciences Effect of parent training program to improve occupation of play in children with autism Developing a parent training program to improve occupation of play in children with autism spectrum disorder and investigating its effect on children's play skills and parental self-efficacy 2023-12-22 anticipated 62 Complete https://irct.ir/trial/72447 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, the stratified randomization method is used and the participants are divided into different subgroups based on the child's level of play. Within each subgroup, a block randomization procedure with blocks of 4 was used to ensure equal representation of participants in each treatment group, and to minimize imbalances over time. This combination of stratified and block randomization is performed using R software, which increases accuracy and reduces human error. The software determines the appropriate blocks and allocates the samples, which ensures that the allocation process is truly random, Blinding description: In this study, the outcome assessors and the statistical data analyst will be unaware of allocating participants to the intervention and control groups. To ensure proper blinding, each participant will be assigned identifiers without specific information about groups. Also, any signs or symbols associated with the allocation group in the data and materials provided to the evaluator will be removed. The statistical analyst also faces only two groups ("Group 1" and "Group 2"), without knowing which one is related to the intervention group and which one is to the control group. The true identity of the groups will not be revealed until the statistical analyses are completed and before the results are presented. This blinding is done to avoid any bias or indirect influence in the evaluation and analysis process. N/A Autism spectrum disorder. Intervention 1: Intervention group: The intervention group in this study is parents of children with autism spectrum disorder who will receive the parent training program. This program is developed based on occupational performance coaching and will be held once a week for 12 sessions. The duration of each session will be 45 to 60 minutes. Intervention 2: Control group: The control group in this study is parents of children with autism spectrum disorder who will not receive any intervention. Yes - There is a plan to make this available What will be shared: IDP: Once participants have been anonymized, we will share the data in an article. This article will discuss the effect of parent training program to improve occupation of play in children with autism and parental self-efficacy. The correlation of study findings will be examined with demographic information and made publicly available. Study protocol: We will present the study's methodology in a paper. Informed consent form: The details regarding informed consent form can be found in the proposal of this study. Clinical study report: We will disseminate the clinical study report within a separate research paper. When: Access to the data will be possible from one month after the publication of the results. To whom: After publishing the paper, it will be accessible to researchers. Conditions: The access depends on the journal in which we will publish the study results. Where to obtain: Reach out to jamshidian.ot@gmail.com for any related information. How to obtain: We cannot disclose data before it is published. Please be patient until the results are published. Comments:
public Ehsan Jamshidian
Occupational therapy department, University of social welfare and rehabilitation sciences, Kodakyar Ave., Daneshjo Blvd.,Evin
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0063 jamshidian.ot@gmail.com University of social welfare and rehabilitation sciences scientific Hooshang Mirzaie
Occupational therapy department, University of social welfare and rehabilitation sciences, Kodakyar Ave., Daneshjo Blvd.,Evin
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0063 hooshang_mirzaie@yahoo.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Parental consent to participate in the study by obtaining written consent Having a child in the age range of 3 to 6 years Receive a diagnosis of autism spectrum disorder by a child psychiatrist Obtaining a score of 54 and above on the Gilliam Autism Rating Scale Being in level 1 or 2 of autism spectrum disorder Availability of at least one parent who can continuously participate in educational and research workouts A stable course of the child's rehabilitation, medication, and school for at least one month prior to the start of the evaluations (no foreseeable change during participation in the study) Having at least a diploma in order to complete questionnaires and receive training 3 years 6 years Both Participating in another intensive treatment program for more than 10 hours per week The presence of severe behavioral or emotional problems in the child Diagnosis of psychiatric disorders in parents based on structured clinical interview for DSM-5 disorders (SCID-5) The presence of severe medical problems, such as blindness, deafness, and epilepsy in a child Insufficient parental commitment for participation in the intervention F84.0 Autistic disorder Rehabilitation N/A Intervention group: The intervention group in this study is parents of children with autism spectrum disorder who will receive the parent training program. This program is developed based on occupational performance coaching and will be held once a week for 12 sessions. The duration of each session will be 45 to 60 minutes. Control group: The control group in this study is parents of children with autism spectrum disorder who will not receive any intervention. Play skills. Timepoint: At the beginning of the study and 3 and 4 months after the start of the parent education program. Method of measurement: Test of Playfulness (ToP). Severity of autism symptoms. Timepoint: At the beginning of the study and 3 and 4 months after the start of the parent training program. Method of measurement: Autism Treatment Evaluation Checklist (ATEC). Parental stress. Timepoint: At the beginning of the study and 3 and 4 months after the start of the parent training program. Method of measurement: Parent Stress Index (PSI). Parental self-efficacy. Timepoint: At the beginning of the study and 3 and 4 months after the start of the parent education program. Method of measurement: Tool to Measure Parenting Self-Efficacy (TOPSE). University of social welfare and rehabilitation sciences Approved 2023-08-22 Research Ethics Committees of University of Social Welfare and Rehabilitation Sciences Occupational therapy department, University of social welfare and rehabilitation sciences, Kodakyar Ave., Daneshjo Blvd.,Evin Tehran Tehran Iran (Islamic Republic of)