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

Primary Purpose

Autism Spectrum Disorder, Executive Function, Patient Participation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cognitive Orientation Approach
Ayres Sensory Integration Therapy
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Cognitive Orientation, Ayres Sensory Integration

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bezmialem Vakıf UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Orientation Approach + Ayres Sensory Integration Therapy

Ayres Sensory Integration Therapy Only

Arm Description

Cognitive Orientation Approach on Daily Occupational Performance (CO-OP) and Ayres Sensory Integration (ASI) Therapy will be applied together

Only Ayres Sensory Integration (ASI) Therapy will be applied

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 7, 2023
Last Updated
September 20, 2023
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT06038435
Brief Title
The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Executive Function, Patient Participation
Keywords
Autism Spectrum Disorder, Cognitive Orientation, Ayres Sensory Integration

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Orientation Approach + Ayres Sensory Integration Therapy
Arm Type
Experimental
Arm Description
Cognitive Orientation Approach on Daily Occupational Performance (CO-OP) and Ayres Sensory Integration (ASI) Therapy will be applied together
Arm Title
Ayres Sensory Integration Therapy Only
Arm Type
Active Comparator
Arm Description
Only Ayres Sensory Integration (ASI) Therapy will be applied
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Orientation Approach
Intervention Description
Cognitive training will be given for the selected occupation
Intervention Type
Behavioral
Intervention Name(s)
Ayres Sensory Integration Therapy
Intervention Description
Sensory integration therapy will be applied.
Primary Outcome Measure Information:
Title
The Behavior Rating Inventory of Executive Function
Description
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.
Time Frame
10 weeks
Title
The Executive Function and Occupational Routines Scale
Description
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.
Time Frame
10 weeks
Title
The Short Child Occupational Profile
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Canadian Occupational Performance Measure
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bezmialem Vakıf University
City
Istanbul
State/Province
İ̇stanbul
ZIP/Postal Code
34762
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeynep Çorakcı Yazıcıoğlu
Phone
+905376699979
Email
zcorakci@bezmialem.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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