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Completed

NCT Number: NCT06038435

The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder

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.

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Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf University

Istanbul, İ̇stanbul, 34762, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Orientation Approach

Behavioral

Cognitive training will be given for the selected occupation

Ayres Sensory Integration Therapy

Behavioral

Sensory integration therapy will be applied.

Primary outcomes

  1. The Behavior Rating Inventory of Executive Function

    Time frame: 10 weeks

    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.

  2. The Executive Function and Occupational Routines Scale

    Time frame: 10 weeks

    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.

  3. The Short Child Occupational Profile

    Time frame: 10 weeks

    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.

Secondary outcomes

  1. Canadian Occupational Performance Measure

    Time frame: 10 weeks

    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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

The Effect of Cognitive Orientation Approach on Daily Occupational Performance on Executive Functions and Occupational Participation in Children With Autism Spectrum Disorder: Randomized Controlled Study With 1 Month Follow-up

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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