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IRCT20260207068781N1 IRCT 2026-03-15 Ahvaz University of Medical Sciences The effect of CO-OP approach on occupational and motor performances in children with Autism spectrum disorder 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 2026-04-09 anticipated 30 Complete https://irct.ir/trial/88986 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. N/A Children with high-functioning Autism Spectrum disorder. Intervention 1: Intervention group: Intervention group: In addition to receiving routine treatment, children in the intervention group will receive an intervention based on the Cognitive Orientation to daily Occupational Performance (CO-OP) approach. This intervention is designed based on the standard protocol developed by Helen Polatajko et al. and has a specific, staged structure and is based on cognitive learning. The intervention consists of 12 sessions of 45 to 60 minutes, two days a week for six weeks. The sessions are held in a controlled environment of occupational therapy centers or special schools for autism, and each session consists of three stages: review of goals and planning (5 minutes), active practice with the “goal-plan-do-check” cycle (30 minutes), and final feedback (10 minutes). To maintain motivation and prevent fatigue, activities are divided into shorter intervals and 2–3 minute breaks, symbolic games, and a reward system are applied. Parents will also be present at some sessions to observe the intervention process and receive the necessary training to transfer the strategies to the home and school environment. The CO-OP intervention consists of three main phases: 1. Preparation (sessions 1 and 2): Includes an initial assessment with COPM and BOT-2 to identify person-centered goals and training in the general CO-OP strategy and self-talk. 2. Skill acquisition and intervention (sessions 3 to 11): Practicing strategies on the child's chosen goals using guided discovery and dynamic performance analysis, along with training parents to transfer the strategies. 3. Reassessment (session 12): Measuring changes in performance and satisfaction with COPM and changes in motor skills with BOT-2 and providing feedback and guidance to parents to generalize the strategies in the child's daily life. Intervention 2: Control group: Children in the control group will receive routine occupational therapy at the center. This treatment includes a set of standard and common occupational therapy interventions that are usually provided in rehabilitation centers for children with autism spectrum disorder and aims to improve motor function, participation in daily activities, and increase social and play skills. Routine therapy interventions include sensory-motor activities, gross and fine motor skill practice, activities related to personal care and daily living, and play therapy. In this group, unlike the CO-OP intervention group, explicit training in cognitive strategies and systematic use of the “goal-plan-do-control” cycle will not be provided. Pre-test and post-test assessments will be conducted for all participants in the control group using the COPM and BOT-2 research instruments to measure changes in occupational performance, satisfaction with performance, and motor skills. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Seifolah Jahantabi Nejad
Golestan Ave
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3333 7352 jahantabi-s@ajums.ac.ir Ahvaz University of Medical Sciences scientific Seifolah Jahantabi Nejad
Golestan Ave
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3333 7352 jahantabi-s@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Children must be between the ages of 7 and 12. Having high-functioning autism spectrum disorder (based on the ASSQ questionnaire) and a diagnosis from a pediatric psychiatrist. Have the ability to communicate verbally in Persian. An IQ greater than or equal to 70 (based on the WISC Children's Test or its equivalent in the medical record). No intellectual disability or progressive neurological disorders. Completion of informed consent by the child or parent. 7 years 12 months Both Unwillingness of the child or parent to continue participation at any stage prior to randomization. F84.0 Autistic disorder Treatment - Other Treatment - Other Intervention group: Intervention group: In addition to receiving routine treatment, children in the intervention group will receive an intervention based on the Cognitive Orientation to daily Occupational Performance (CO-OP) approach. This intervention is designed based on the standard protocol developed by Helen Polatajko et al. and has a specific, staged structure and is based on cognitive learning. The intervention consists of 12 sessions of 45 to 60 minutes, two days a week for six weeks. The sessions are held in a controlled environment of occupational therapy centers or special schools for autism, and each session consists of three stages: review of goals and planning (5 minutes), active practice with the “goal-plan-do-check” cycle (30 minutes), and final feedback (10 minutes). To maintain motivation and prevent fatigue, activities are divided into shorter intervals and 2–3 minute breaks, symbolic games, and a reward system are applied. Parents will also be present at some sessions to observe the intervention process and receive the necessary training to transfer the strategies to the home and school environment. The CO-OP intervention consists of three main phases: 1. Preparation (sessions 1 and 2): Includes an initial assessment with COPM and BOT-2 to identify person-centered goals and training in the general CO-OP strategy and self-talk. 2. Skill acquisition and intervention (sessions 3 to 11): Practicing strategies on the child's chosen goals using guided discovery and dynamic performance analysis, along with training parents to transfer the strategies. 3. Reassessment (session 12): Measuring changes in performance and satisfaction with COPM and changes in motor skills with BOT-2 and providing feedback and guidance to parents to generalize the strategies in the child's daily life. Control group: Children in the control group will receive routine occupational therapy at the center. This treatment includes a set of standard and common occupational therapy interventions that are usually provided in rehabilitation centers for children with autism spectrum disorder and aims to improve motor function, participation in daily activities, and increase social and play skills. Routine therapy interventions include sensory-motor activities, gross and fine motor skill practice, activities related to personal care and daily living, and play therapy. In this group, unlike the CO-OP intervention group, explicit training in cognitive strategies and systematic use of the “goal-plan-do-control” cycle will not be provided. Pre-test and post-test assessments will be conducted for all participants in the control group using the COPM and BOT-2 research instruments to measure changes in occupational performance, satisfaction with performance, and motor skills. Comparison of occupational performance scores in children with Autism spectrum disorder. Timepoint: At the beginning of the study (before the intervention) and immediately after the end of the intervention (post-test). Method of measurement: Canadian Occupational Performance Measure. Comparing satisfaction with occupational performance of children with Autism spectrum disorder. Timepoint: At the beginning of the study (before the intervention) and immediately after the end of the intervention (post-test). Method of measurement: Canadian Occupational Performance Measure. Comparison of motor skills scores of children with Autism spectrum disorder. Timepoint: At the beginning of the study (before the intervention) and immediately after the end of the intervention (post-test). Method of measurement: Bruininks-Oseretsky Test Of Motor Proficiency, Second Edition. Ahvaz University of Medical Sciences Approved 2026-01-31 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz - University City - Ahvaz Jundishapur University of Medical Sciences - Vice Chancellor for Research and Technology - First Floor - University Research Ethics Working Group Unit Ahvaz Khouzestan Iran (Islamic Republic of)