Ayres Sensory Integration Therapy on Occupational Performance in Children With Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ayres Sensory Integration Therapy
Home Program
Sponsored by
About this trial
This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring Ayres Sensory Integration, Occupational Performance
Eligibility Criteria
Inclusion Criteria: Children diagnosed with Autism Spectrum Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Level 1 (requiring support) and Level 2 (requiring substantial support) are severity levels for Autism Spectrum Disorder Age at first and second test between 3 years and 10 years Exclusion Criteria: Accompanying neurodevelopmental, psychiatric, neurological or physical diagnosis
Sites / Locations
- Bezmialem Vakıf University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Control Group
Arm Description
Ayres Sensory Integration Therapy and Home Program
Home Program
Outcomes
Primary Outcome Measures
Occupational Performance
Occupational performance will be evaluated with Canadian Occupational Performance Measure (COPM). The measure is a goal-oriented, individualized, client-centered tool in which participants can set different goals in self-care, productivity, and leisure.
The measure is a semi-structured assessment applied to determine the daily activities that participants have difficulty with.
All activities said by the participants are scored between 1-10 points and the first five activities are selected.
These activities are also scored between 1-10 points according to performance and satisfaction.
Scores are compared by applying the same scale after the intervention.
Secondary Outcome Measures
Full Information
NCT ID
NCT05718362
First Posted
January 6, 2023
Last Updated
May 24, 2023
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT05718362
Brief Title
Ayres Sensory Integration Therapy on Occupational Performance in Children With Autism Spectrum Disorder
Official Title
Investigation of the Effect of Ayres Sensory Integration Therapy on Occupational Performance in Children With Autism Spectrum Disorder: A Randomized Control
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2023 (Actual)
Primary Completion Date
May 24, 2023 (Actual)
Study Completion Date
May 24, 2023 (Actual)
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
Ayres Sensory Integration (ASI) Therapy is an individualized intervention designed to address specific underlying sensorimotor issues that may affect children's performance during daily routines and occupations. The intervention takes place in the context of play, emphasizes the active participation of the child, involves a collaborative relationship between the occupational therapist and the child, and focuses on participation-oriented outcomes that are collected at regular intervals throughout the intervention program. In general, its content is to improve the child's occupational performance.
The program, which will be carried out in accordance with the Ayres Sensory Integration Fidelity Measure®, it is aimed to reduce the autism-specific symptoms of the child with autism and the dependence of the child on the caregiver in self-care activities. It is predicted that this whole process will increase the participation and his performance of the child with autism in his occupations related to his daily life.
H0: Ayres Sensory Integration Therapy has no effect on the occupational performance of the child 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
Keywords
Ayres Sensory Integration, Occupational Performance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups will be formed as study and control. A simple random distribution will be made when creating groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Ayres Sensory Integration Therapy and Home Program
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Home Program
Intervention Type
Behavioral
Intervention Name(s)
Ayres Sensory Integration Therapy
Intervention Description
It is an intervention method whose effectiveness is questioned. It is a therapy program applied according to Ayres Sensory Integration Fidelity Measure.
Intervention Type
Behavioral
Intervention Name(s)
Home Program
Intervention Description
These are the activities created for the participants (both intervention and control groups) and to be done in the home environment.
Primary Outcome Measure Information:
Title
Occupational Performance
Description
Occupational performance will be evaluated with Canadian Occupational Performance Measure (COPM). The measure is a goal-oriented, individualized, client-centered tool in which participants can set different goals in self-care, productivity, and leisure.
The measure is a semi-structured assessment applied to determine the daily activities that participants have difficulty with.
All activities said by the participants are scored between 1-10 points and the first five activities are selected.
These activities are also scored between 1-10 points according to performance and satisfaction.
Scores are compared by applying the same scale after the intervention.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children diagnosed with Autism Spectrum Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
Level 1 (requiring support) and Level 2 (requiring substantial support) are severity levels for Autism Spectrum Disorder
Age at first and second test between 3 years and 10 years
Exclusion Criteria:
Accompanying neurodevelopmental, psychiatric, neurological or physical diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Çorakcı
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakıf University
City
Istanbul
State/Province
İ̇stanbul
ZIP/Postal Code
34762
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ayres Sensory Integration Therapy on Occupational Performance in Children With Autism Spectrum Disorder
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