The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 4, 2023
CompletedFirst Submitted
Initial submission to the registry
September 7, 2023
CompletedFirst Posted
Study publicly available on registry
September 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedFebruary 7, 2024
February 1, 2024
5 months
September 7, 2023
February 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (1)
Canadian Occupational Performance Measure
10 weeks
Study Arms (2)
Cognitive Orientation Approach + Ayres Sensory Integration Therapy
EXPERIMENTALCognitive Orientation Approach on Daily Occupational Performance (CO-OP) and Ayres Sensory Integration (ASI) Therapy will be applied together
Ayres Sensory Integration Therapy Only
ACTIVE COMPARATOROnly Ayres Sensory Integration (ASI) Therapy will be applied
Interventions
Cognitive training will be given for the selected occupation
Sensory integration therapy will be applied.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Having a concomitant neurological, psychiatric or orthopedic diagnosis
- Attending a program other than individual education
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bezmialem Vakıf University
Istanbul, İ̇stanbul, 34762, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
September 7, 2023
First Posted
September 14, 2023
Study Start
September 4, 2023
Primary Completion
January 31, 2024
Study Completion
January 31, 2024
Last Updated
February 7, 2024
Record last verified: 2024-02