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The Effect Of Occupational Therapy On Sensory-Based Feeding Problems

Primary Purpose

Feeding Disorder, Autism Spectrum Disorder, Sensory Integration Disorder (Disorder)

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Family Training
Occupational Therapy
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feeding Disorder

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASD
  • Feeding problems

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    Children with ASD

    Children with ASD

    Outcomes

    Primary Outcome Measures

    Dunn Sensory Profile
    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

    Secondary Outcome Measures

    BAMBİ
    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.
    STEP
    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

    Full Information

    First Posted
    January 18, 2019
    Last Updated
    January 27, 2019
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03820869
    Brief Title
    The Effect Of Occupational Therapy On Sensory-Based Feeding Problems
    Official Title
    The Effect Of Occupational Therapy On Sensory-Based Feeding Problems Of Children Wth Autism Spectrum Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2019 (Anticipated)
    Primary Completion Date
    May 2019 (Anticipated)
    Study Completion Date
    July 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Feeding Disorder, Autism Spectrum Disorder, Sensory Integration Disorder (Disorder)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    18 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Children with ASD
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Children with ASD
    Intervention Type
    Other
    Intervention Name(s)
    Family Training
    Intervention Description
    Family Training
    Intervention Type
    Other
    Intervention Name(s)
    Occupational Therapy
    Intervention Description
    Occupational Therapy
    Primary Outcome Measure Information:
    Title
    Dunn Sensory Profile
    Description
    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
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    BAMBİ
    Description
    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.
    Time Frame
    8 weeks
    Title
    STEP
    Description
    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
    Time Frame
    8 weeks

    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: ASD Feeding problems

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect Of Occupational Therapy On Sensory-Based Feeding Problems

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