NCT06038435

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

September 7, 2023

Last Update Submit

February 6, 2024

Conditions

Keywords

Autism Spectrum DisorderCognitive OrientationAyres Sensory Integration

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

EXPERIMENTAL

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

Behavioral: Cognitive Orientation ApproachBehavioral: Ayres Sensory Integration Therapy

Ayres Sensory Integration Therapy Only

ACTIVE COMPARATOR

Only Ayres Sensory Integration (ASI) Therapy will be applied

Behavioral: Ayres Sensory Integration Therapy

Interventions

Cognitive training will be given for the selected occupation

Cognitive Orientation Approach + Ayres Sensory Integration Therapy

Sensory integration therapy will be applied.

Ayres Sensory Integration Therapy OnlyCognitive Orientation Approach + Ayres Sensory Integration Therapy

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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)

Location

MeSH Terms

Conditions

Autism Spectrum DisorderPatient ParticipationOrientation, Spatial

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorSpatial Behavior

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

Locations