<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03820869</url>
  </required_header>
  <id_info>
    <org_study_id>2018/454</org_study_id>
    <nct_id>NCT03820869</nct_id>
  </id_info>
  <brief_title>The Effect Of Occupational Therapy On Sensory-Based Feeding Problems</brief_title>
  <official_title>The Effect Of Occupational Therapy On Sensory-Based Feeding Problems Of Children Wth Autism Spectrum Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Feeding problems are common in individuals with Autism Spectrum Disorder (ASD).This study was&#xD;
      planned to investigate the effect of occupational theraphy on sensory feeding problems in&#xD;
      ASD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Feeding problems are common in individuals with Autism Spectrum Disorder (ASD).This study was&#xD;
      planned to investigate the effect of occupational theraphy on sensory feeding problems in&#xD;
      ASD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dunn Sensory Profile</measure>
    <time_frame>8 weeks</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BAMBİ</measure>
    <time_frame>8 weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STEP</measure>
    <time_frame>8 weeks</time_frame>
    <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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Feeding Disorder</condition>
  <condition>Autism Spectrum Disorder</condition>
  <condition>Sensory Integration Disorder (Disorder)</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Children with ASD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children with ASD</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Family Training</intervention_name>
    <description>Family Training</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Occupational Therapy</intervention_name>
    <description>Occupational Therapy</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASD&#xD;
&#xD;
          -  Feeding problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 27, 2019</last_update_submitted>
  <last_update_submitted_qc>January 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Özgü İNAL</investigator_full_name>
    <investigator_title>Assoc Prof</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Feeding and Eating Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03820869
org study id: 2018/454
nct id: NCT03820869
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dunn Sensory Profile
time frame: 8 weeks
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
measure: BAMBİ
time frame: 8 weeks
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.
measure: STEP
time frame: 8 weeks
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
arm group label: Control
arm group type: Active Comparator
description: Children with ASD
arm group label: Intervention
arm group type: Experimental
description: Children with ASD
intervention type: Other
intervention name: Family Training
description: Family Training
arm group label: Control
intervention type: Other
intervention name: Occupational Therapy
description: Occupational Therapy
arm group label: Intervention
criteria: 
gender: All
minimum age: 3 Years
maximum age: 10 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Özgü İNAL
investigator title: Assoc Prof
mesh term: Autism Spectrum Disorder
mesh term: Feeding and Eating Disorders