- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03820869
The Effect Of Occupational Therapy On Sensory-Based Feeding Problems
January 27, 2019 updated by: Özgü İNAL, Hacettepe University
The Effect Of Occupational Therapy On Sensory-Based Feeding Problems Of Children Wth Autism Spectrum Disorder
Feeding problems are common in individuals with Autism Spectrum Disorder (ASD).This study was planned to investigate the effect of occupational theraphy on sensory feeding problems in ASD.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Feeding problems are common in individuals with Autism Spectrum Disorder (ASD).This study was planned to investigate the effect of occupational theraphy on sensory feeding problems in ASD.
Study Type
Interventional
Enrollment (Anticipated)
18
Phase
- Not Applicable
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
3 years to 10 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASD
- Feeding problems
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: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Control
Children with ASD
|
Family Training
|
EXPERIMENTAL: Intervention
Children with ASD
|
Occupational Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dunn Sensory Profile
Time Frame: 8 weeks
|
It is a norm-referenced, parent-report questionnaire.
The parent rates frequency of each item on a 5-point Likert scale from 1= always to 5= never.
It reports the frequency of behavioural occurrences that are used to measure the patterns of performance indicative of difficulties experienced in sensory processing
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BAMBİ
Time Frame: 8 weeks
|
The BAMBI is rated based on a parent proxy report, with a 5-point grading type scale (1 = Never/Very Rarely -5 = At Almost All Mealtimes).
It was designed to capture mealtime behaviors specific to children with ASD.
|
8 weeks
|
STEP
Time Frame: 8 weeks
|
It is used for to identify the feeding problems of persons with ID in terms of (a) risk of aspiration, (b) food selectivity, (c) feeding skills deficits, (d) food refusal and associated behavior problems, and (e) nutrition-related behavior problems
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ANTICIPATED)
March 1, 2019
Primary Completion (ANTICIPATED)
May 1, 2019
Study Completion (ANTICIPATED)
July 1, 2019
Study Registration Dates
First Submitted
January 18, 2019
First Submitted That Met QC Criteria
January 27, 2019
First Posted (ACTUAL)
January 29, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 29, 2019
Last Update Submitted That Met QC Criteria
January 27, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/454
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.
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