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

February 6, 2024 updated by: Zeynep Çorakcı Yazıcıoğlu, Bezmialem Vakif University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İ̇stanbul
      • Istanbul, İ̇stanbul, Turkey, 34762
        • Bezmialem Vakıf University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Orientation Approach + Ayres Sensory Integration Therapy
Cognitive Orientation Approach on Daily Occupational Performance (CO-OP) and Ayres Sensory Integration (ASI) Therapy will be applied together
Behavioral: Ayres Sensory Integration Therapy
Sensory integration therapy will be applied.
Behavioral: Cognitive Orientation Approach
Cognitive training will be given for the selected occupation
Active Comparator: Ayres Sensory Integration Therapy Only
Only Ayres Sensory Integration (ASI) Therapy will be applied
Behavioral: Ayres Sensory Integration Therapy
Sensory integration therapy will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 weeks
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.
10 weeks
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.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2023

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

September 7, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORAKCİ-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autism Spectrum Disorder

Clinical Trials on Ayres Sensory Integration Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe