<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/NCT03232775</url>
  </required_header>
  <id_info>
    <org_study_id>07-0362</org_study_id>
    <nct_id>NCT03232775</nct_id>
  </id_info>
  <brief_title>Use of a Visual Pedagogy and Structure With Children With Autism for Routine Physical Exams</brief_title>
  <official_title>Evaluating the Effects of a Visual Pedagogy and Structure on the Successful Completion of the Medical Office Visit and Physical Examination With Pre-pubescent Children With Autism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital Colorado</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</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>
      Children with autism spectrum disorders (ASDs) have unique social-communication and behavior&#xD;
      impairments that complicate their medical management. This study aimed to evaluate the&#xD;
      effectiveness of using a picture schedule paired with a reinforcement system during the&#xD;
      medical exam. Two groups (treatment and control) of children (ages 5 - 10 yrs) diagnosed with&#xD;
      ASD and below average adaptive communication impairment were asked to participate. Following&#xD;
      participation in an overview of autism diagnostic symptoms training, two teams (comprised of&#xD;
      one chief medical resident and one nurse), blind to the study aim, conducted the study exams.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: This pilot study aimed to evaluate the effects of a picture-schedule reinforcement&#xD;
      system on reducing problem behaviors in children with Autism Spectrum Disorder (ASD) during a&#xD;
      physical exam.&#xD;
&#xD;
      Design, setting, patients, intervention: Fifteen study participants, aged 5-10 years, with&#xD;
      autism and identified by caregivers as typically uncooperative with physical exams were&#xD;
      randomized to one of two physical exam groups (treatment and control) based on their adaptive&#xD;
      communication score. The treatment group exam included use of a picture&#xD;
      schedule-reinforcement book and the control group exam did not introduce the book. Caregivers&#xD;
      rated participants' irritability/stereotypy behaviors before and during study exams. Exam&#xD;
      teams blinded to study aims, recorded participants' total exam items completed and caregivers&#xD;
      rated participants' level of cooperation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2007</start_date>
  <completion_date type="Actual">August 2011</completion_date>
  <primary_completion_date type="Actual">August 2011</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>Supportive Care</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>The medical examination teams (one chief medical resident and one nurse) will be blind to the study aim.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline on the Aberrant Behavior Checklist-Community measure ( irritability and stereotypy subscales)</measure>
    <time_frame>The end of the 15-minute waiting period and within 15 minutes after the completion of physical exam</time_frame>
    <description>Caregiver report form of subjects' behaviors.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of study exam items completed during study exams</measure>
    <time_frame>Within 15 minutes after conclusion of each participant's study exam.</time_frame>
    <description>Study medical personnel teams (nurse and medical resident) tallied number of total exam items completed during study exams with each participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Cooperation likert-scale rating form</measure>
    <time_frame>At study entry and within 15 minutes after the completion of study physical exams</time_frame>
    <description>Caregiver report form of subjects' cooperation behaviors during study physical exams.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment: Physical Exam with Visual Pedagogy and Structure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control: Physical Exam without Visual Pedagogy and Structure</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment: Physical Exam with Visual Pedagogy and Structure</intervention_name>
    <description>Routine physical examination participants receive visual pedagogy and reinforcement (preferred food treat).</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control: Physical Exam without Visual Pedagogy and Structure</intervention_name>
    <description>Participants engage in routine physical examination without visual pedagogy and reinforcement (preferred food treat).</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Chronological ages 4 to 10 years.&#xD;
&#xD;
          2. Presumptive diagnosis of Autistic Disorder or Asperger's Disorder prior to study&#xD;
             admission from a psychologist or psychiatrist experienced with children who have&#xD;
             autism.&#xD;
&#xD;
          3. Meets research criteria for Autistic Spectrum Disorder:&#xD;
&#xD;
               1. Meets cut-off scores for autism spectrum on the Social Communication&#xD;
                  Questionnaire (SCQ) (cut-off = 15) and&#xD;
&#xD;
               2. Meets empirically-derived algorithm cut-off scores for Autism Spectrum Disorders&#xD;
                  on the Autism Diagnostic Observation Schedule (ADOS).&#xD;
&#xD;
               3. All subjects will have the ADOS administered by a clinician trained in research&#xD;
                  reliability standards.&#xD;
&#xD;
               4. The Principal Investigator, a certified ADOS trainer and research reliable, or&#xD;
                  trained designee under the supervision of the Principal Investigator, will&#xD;
                  administer the ADOS.&#xD;
&#xD;
          4. Participants will represent the typical DSM-IV diagnostic developmental profile of&#xD;
             children on the autism spectrum and no neurological injuries or illnesses before the&#xD;
             age of three years that could account for their symptoms (i.e., meningitis,&#xD;
             encephalitis, severe head injury or seizure disorder).&#xD;
&#xD;
          5. A Communication standard score ≤ 85, as measured by the Vineland Adaptive Behavior&#xD;
             Scales - II.&#xD;
&#xD;
             a) The VABS-II will be administered by the Principal Investigator or trained designee&#xD;
             under the supervision of the Principal Investigator as part of the initial phone&#xD;
             screening process.&#xD;
&#xD;
          6. Children with an ASD, particularly school-aged children and adolescents, may present&#xD;
             with myriad prescribed psychotropic medications. Therefore, we will not exclude&#xD;
             children on a variety of psychotropic medications; rather we will conduct a&#xD;
             qualitative analysis to look at this issue.&#xD;
&#xD;
          7. No restrictions regarding race or gender will be applied to the autism or&#xD;
             developmental disability sample. Every effort will be made not to over-represent any&#xD;
             particular race and/or gender group.&#xD;
&#xD;
          8. Physically healthy prior to physical exam.&#xD;
&#xD;
          9. Previous exposure to visual systems. This will be assessed based on caregiver report&#xD;
             during the phone screening using one question relating to the use of visual structure&#xD;
             with the child.&#xD;
&#xD;
         10. History of:&#xD;
&#xD;
               1. Poor Cooperation&#xD;
&#xD;
               2. Completely Uncooperative&#xD;
&#xD;
               3. Physical exams rated by caregiver on 4-point scale of cooperation modified from&#xD;
                  Forsberg et al. [56].&#xD;
&#xD;
                    -  0 = No problems with cooperation;&#xD;
&#xD;
                    -  1 = Minor problems with cooperation: Child shows mild behavior problems&#xD;
                       and/or anxiety symptoms;&#xD;
&#xD;
                    -  2 = Poor cooperation: Child's behavior problems and/or anxiety symptoms&#xD;
                       requires that the medical staff have to spend extra time and effort to&#xD;
                       manage the child and complete the exam;&#xD;
&#xD;
                    -  3 = Completely uncooperative: Exam is not possible due to child's behavior&#xD;
                       problems and/or anxiety symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participants with intelligence quotient standard scores &gt; 40.&#xD;
&#xD;
          2. Presence of the following genetic or progressive neurological disorders known to be&#xD;
             causative of or potentially resulting in a phenotype similar to autism:&#xD;
&#xD;
               1. Fragile X,&#xD;
&#xD;
               2. Landau Kleffner, Rett Disorder,&#xD;
&#xD;
               3. Childhood Disintegrative Disorder, or&#xD;
&#xD;
               4. Tuberous Sclerosis, based on screening by clinical staff and subsequent review by&#xD;
                  medical staff as needed&#xD;
&#xD;
          3. Presence of vision or hearing loss or significant motor impairments.&#xD;
&#xD;
          4. Wards of the State.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robin Gabriels, PsyD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>visual pedagogy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03232775
org study id: 07-0362
nct id: NCT03232775
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Children with autism spectrum disorders (ASDs) have unique social-communication and behavior
      impairments that complicate their medical management. This study aimed to evaluate the
      effectiveness of using a picture schedule paired with a reinforcement system during the
      medical exam. Two groups (treatment and control) of children (ages 5 - 10 yrs) diagnosed with
      ASD and below average adaptive communication impairment were asked to participate. Following
      participation in an overview of autism diagnostic symptoms training, two teams (comprised of
      one chief medical resident and one nurse), blind to the study aim, conducted the study exams.
Objective: This pilot study aimed to evaluate the effects of a picture-schedule reinforcement
      system on reducing problem behaviors in children with Autism Spectrum Disorder (ASD) during a
      physical exam.

      Design, setting, patients, intervention: Fifteen study participants, aged 5-10 years, with
      autism and identified by caregivers as typically uncooperative with physical exams were
      randomized to one of two physical exam groups (treatment and control) based on their adaptive
      communication score. The treatment group exam included use of a picture
      schedule-reinforcement book and the control group exam did not introduce the book. Caregivers
      rated participants' irritability/stereotypy behaviors before and during study exams. Exam
      teams blinded to study aims, recorded participants' total exam items completed and caregivers
      rated participants' level of cooperation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Care Provider)
masking description: The medical examination teams (one chief medical resident and one nurse) will be blind to the study aim.
measure: Change from baseline on the Aberrant Behavior Checklist-Community measure ( irritability and stereotypy subscales)
time frame: The end of the 15-minute waiting period and within 15 minutes after the completion of physical exam
description: Caregiver report form of subjects' behaviors.
measure: Number of study exam items completed during study exams
time frame: Within 15 minutes after conclusion of each participant's study exam.
description: Study medical personnel teams (nurse and medical resident) tallied number of total exam items completed during study exams with each participant
measure: Change from baseline in Cooperation likert-scale rating form
time frame: At study entry and within 15 minutes after the completion of study physical exams
description: Caregiver report form of subjects' cooperation behaviors during study physical exams.
arm group label: Treatment
arm group type: Other
description: Treatment: Physical Exam with Visual Pedagogy and Structure
arm group label: Control
arm group type: Other
description: Control: Physical Exam without Visual Pedagogy and Structure
intervention type: Other
intervention name: Treatment: Physical Exam with Visual Pedagogy and Structure
description: Routine physical examination participants receive visual pedagogy and reinforcement (preferred food treat).
arm group label: Treatment
intervention type: Other
intervention name: Control: Physical Exam without Visual Pedagogy and Structure
description: Participants engage in routine physical examination without visual pedagogy and reinforcement (preferred food treat).
arm group label: Control
criteria: 
gender: All
minimum age: 4 Years
maximum age: 10 Years
healthy volunteers: No
last name: Robin Gabriels, PsyD
role: Principal Investigator
affiliation: University of Colorado, Denver
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: No