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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06038435
Other study ID # CORAKCI-004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 4, 2023
Est. completion date January 31, 2024

Study information

Verified date February 2024
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is by using the Cognitive Orientation Approach on Daily Occupational Performance, which is also supported by the literature and applied by occupational therapists, in children diagnosed with Autism Spectrum Disorder, it is aimed to determine how children's executive function scores and occupational participation change. The main questions it aims to answer are: - Does the Cognitive Orientation Approach on Daily Occupational Performance have an effect on executive functions? - Does the Cognitive Orientation Approach on Daily Occupational Performance have an effect on occupational performance? Participants will: - Evaluations will be applied to all participants - Divided into intervention and control groups - The intervention group will be given "Cognitive Orientation Approach on Daily Occupational Performance" and "Ayres Sensory Integration Therapy" followed up for about 10 weeks. - The control group will be given "Ayres Sensory Integration Therapy" followed up for about 10 weeks. - After 10 weeks, the results between the two groups will be compared. - After the second evaluation, both groups will be followed for 1 month and the same evaluations will be repeated. Researchers will compare intervention and control groups to see executive functions and occupational participation.


Description:

Autism spectrum disorder is a complex developmental disorder that can lead to dysfunctions in cognitive, emotion regulation, and communication skills. At the beginning of the cognitive problems seen in children with autism, the pathophysiology in executive functions, which is affected by individual differences, comes to the fore. Difficulties related to executive functions such as cognitive flexibility and problem solving cause limitations in many basic areas, especially in daily life in autism. The Cognitive Orientation Approach on Daily Occupational Performance, designed by Polatajko and others, is an activity-oriented problem-solving approach that uses cognitive strategies to develop motor skills in children who have difficulties during daily activities; It is a therapy method that focuses on the goal or the task itself, rather than the acquisition of functions within the activity performance. It is known that the approach is effective on social, emotional and organizational skills, especially cognitive skills in children with autism spectrum disorder.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date January 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 7 Years to 11 Years
Eligibility Inclusion Criteria: - Being diagnosed with Autism Spectrum Disorder according to DSM-V by the Department of Child and Adolescent Mental Health - Being between the ages of 7 years and 10 years and 11 months - Score 30-36 points on the Childhood Autism Rating Scale - Participation must be approved by the parent. Exclusion Criteria: - Having a concomitant neurological, psychiatric or orthopedic diagnosis - Attending a program other than individual education

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive Orientation Approach
Cognitive training will be given for the selected occupation
Ayres Sensory Integration Therapy
Sensory integration therapy will be applied.

Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul I?stanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Behavior Rating Inventory of Executive Function It is a rating used to evaluate the behavior of children and adolescents in the home and school environment, taking into account executive functions. It is a likert scale between 1-3 points and a score between 86-258 is obtained. High score is associated with impaired executive function. 10 weeks
Primary The Executive Function and Occupational Routines Scale It evaluates children's skills such as impulsivity, verbal and non-verbal memory, self-regulation, planning and problem solving. It consists of 4 subtests including the total score. It is obtained by dividing each subtest score by the number of questions. It gives a score between 1-5 points. A high score indicates improvement. 10 weeks
Primary The Short Child Occupational Profile The profile provides a comprehensive assessment of the child's activity participation and a holistic consideration of the factors that facilitate or limit occupational participation. It consists of 7 subtests including the total score. It is a likert scale between 1-4 points. While the "environmental" subtest is between 5-20 points, the other subtests are between 4-16 points. A higher score is associated with increased occupational performance. 10 weeks
Secondary Canadian Occupational Performance Measure It is a person-centered approach to establishing treatment goals and assessing perceived performance and satisfaction changes over time. Performance and satisfaction subtests score between 1-5. A higher score is associated with increased occupational performance. 10 weeks
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