- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07740863
Occupational Therapy Intervention in Children Diagnosed With Early and Late Autism Spectrum Disorder
Comparison of the Effects of Occupational Therapy Intervention on Sensory Processing and Executive Functions in Children Diagnosed With Early and Late Autism Spectrum Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- being between 6 and 12 years of age
- having a formal diagnosis of ASD
- actively attending occupational therapy sessions.
Exclusion Criteria:
- Children with severe physical disabilities, significant visual or hearing impairments, or severe cognitive and communication limitations preventing participation in the assessment process were excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control Group
|
A pediatric occupational therapy intervention will be applied to improve children's performance and independence in daily living activities. The intervention will be structured according to the child's individual needs, functional capacity, developmental level, and difficulties in daily living activities. The intervention program will use activities aimed at supporting the child's performance in areas such as self-care, feeding, dressing, toileting, personal care, functional mobility, and participation in daily living routines. During the intervention process, the child's existing skills will be evaluated, and activities suitable for the child will be planned in line with activity analysis and a task-oriented approach. The intervention program will generally include the following components: Assessment of the child's performance in daily living activities Setting individual goals Activity analysis and activity-based intervention Working on self-care and daily living skills |
|
Experimental: Study Group
Occupational Therapy Group
|
A pediatric occupational therapy intervention will be applied to improve children's performance and independence in daily living activities. The intervention will be structured according to the child's individual needs, functional capacity, developmental level, and difficulties in daily living activities. The intervention program will use activities aimed at supporting the child's performance in areas such as self-care, feeding, dressing, toileting, personal care, functional mobility, and participation in daily living routines. During the intervention process, the child's existing skills will be evaluated, and activities suitable for the child will be planned in line with activity analysis and a task-oriented approach. The intervention program will generally include the following components: Assessment of the child's performance in daily living activities Setting individual goals Activity analysis and activity-based intervention Working on self-care and daily living skills |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sociodemographic form
Time Frame: 4 weeks
|
age at diagnosis, weekly therapy frequency, total number of occupational therapy sessions, and sociodemographic data were recorded for all participants.
All assessment forms were completed by caregivers during face-to-face interviews conducted before and after the intervention period.
|
4 weeks
|
|
Sensory Processing Measure-Home (SPM-Home)
Time Frame: 4 weeks
|
The Sensory Processing Measure - Home Form (SPM-H) is a caregiver-reported questionnaire designed to evaluate sensory processing and related functional behaviors in children aged 5 to 12 years (Parham & Ecker, 2007).
The form consists of 75 items and is completed by parents or primary caregivers in approximately 15-20 minutes.
The SPM-H assesses several sensory domains, including vision, hearing, touch, body awareness, and balance and motion.
These subscales contribute to a total sensory score.
In addition, the scale includes social participation and planning/ideas subscales, which reflect higher-order integrative functions influenced by sensory processing.
Items are rated on a four-point frequency scale ranging from "never" to "always," with higher scores indicating greater sensory processing difficulties.
Raw scores are converted into standardized T-scores, which are interpreted as typical performance, some problems, or definite dysfunction.
The Turkish adaptation of the scale demon
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dunn Sensory Profile
Time Frame: 4 weeks
|
The Dunn Sensory Profile is a caregiver-reported questionnaire developed to evaluate sensory processing patterns in children aged 3 to 10 years (Ermer & Dunn, 1998).
It consists of 125 items assessing multiple sensory domains, including auditory, visual, vestibular, tactile, multisensory, and oral sensory processing.
The questionnaire is completed by caregivers who have regular contact with the child in daily life.
Each item is rated on a 5-point frequency scale ranging from "always" to "never."
Higher scores in each subdomain indicate greater difficulties in sensory processing.
The Turkish adaptation of the scale was conducted by Kayıhan et al., demonstrating satisfactory psychometric properties, with Cronbach's alpha coefficients ranging between 0.63 and 0.97 across subdomains.
|
4 weeks
|
|
Executive Function Occupational Routine Scale (EFORTS)
Time Frame: 4 weeks
|
The scale is a parent-reported measure designed to assess children's executive functioning through everyday routines.
It evaluates executive control within three domains: (a) morning and evening routines, (b) play and leisure activities, and (c) social routines.
Parents rate 30 items using a 5-point Likert scale ranging from 1 (never) to 5 (always).
Subscale and total scores are calculated by averaging item responses, with higher scores indicating better executive functioning in daily occupational performance.
The scale also provides a cut-off score to identify the presence of executive dysfunction.
EFORTS can be completed by parents in approximately 15 minutes in various settings.
In the original validation study by Frisch and Rosenblum (2014), internal consistency was high, with subscale reliability coefficients ranging from 0.83 to 0.92 and an overall Cronbach's alpha of 0.947.
Turkish validity and reliability were conducted by Akyurek et al. (2023).
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFSU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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