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Use of a Visual Pedagogy and Structure With Children With Autism for Routine Physical Exams

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treatment: Physical Exam with Visual Pedagogy and Structure
Control: Physical Exam without Visual Pedagogy and Structure
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring visual pedagogy

Eligibility Criteria

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

Inclusion Criteria:

  1. Chronological ages 4 to 10 years.
  2. Presumptive diagnosis of Autistic Disorder or Asperger's Disorder prior to study admission from a psychologist or psychiatrist experienced with children who have autism.
  3. Meets research criteria for Autistic Spectrum Disorder:

    1. Meets cut-off scores for autism spectrum on the Social Communication Questionnaire (SCQ) (cut-off = 15) and
    2. Meets empirically-derived algorithm cut-off scores for Autism Spectrum Disorders on the Autism Diagnostic Observation Schedule (ADOS).
    3. All subjects will have the ADOS administered by a clinician trained in research reliability standards.
    4. The Principal Investigator, a certified ADOS trainer and research reliable, or trained designee under the supervision of the Principal Investigator, will administer the ADOS.
  4. Participants will represent the typical DSM-IV diagnostic developmental profile of children on the autism spectrum and no neurological injuries or illnesses before the age of three years that could account for their symptoms (i.e., meningitis, encephalitis, severe head injury or seizure disorder).
  5. A Communication standard score ≤ 85, as measured by the Vineland Adaptive Behavior Scales - II.

    a) The VABS-II will be administered by the Principal Investigator or trained designee under the supervision of the Principal Investigator as part of the initial phone screening process.

  6. Children with an ASD, particularly school-aged children and adolescents, may present with myriad prescribed psychotropic medications. Therefore, we will not exclude children on a variety of psychotropic medications; rather we will conduct a qualitative analysis to look at this issue.
  7. No restrictions regarding race or gender will be applied to the autism or developmental disability sample. Every effort will be made not to over-represent any particular race and/or gender group.
  8. Physically healthy prior to physical exam.
  9. Previous exposure to visual systems. This will be assessed based on caregiver report during the phone screening using one question relating to the use of visual structure with the child.
  10. History of:

    1. Poor Cooperation
    2. Completely Uncooperative
    3. Physical exams rated by caregiver on 4-point scale of cooperation modified from Forsberg et al. [56].

      • 0 = No problems with cooperation;
      • 1 = Minor problems with cooperation: Child shows mild behavior problems and/or anxiety symptoms;
      • 2 = Poor cooperation: Child's behavior problems and/or anxiety symptoms requires that the medical staff have to spend extra time and effort to manage the child and complete the exam;
      • 3 = Completely uncooperative: Exam is not possible due to child's behavior problems and/or anxiety symptoms

Exclusion Criteria:

  1. Participants with intelligence quotient standard scores > 40.
  2. Presence of the following genetic or progressive neurological disorders known to be causative of or potentially resulting in a phenotype similar to autism:

    1. Fragile X,
    2. Landau Kleffner, Rett Disorder,
    3. Childhood Disintegrative Disorder, or
    4. Tuberous Sclerosis, based on screening by clinical staff and subsequent review by medical staff as needed
  3. Presence of vision or hearing loss or significant motor impairments.
  4. Wards of the State.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Treatment

    Control

    Arm Description

    Treatment: Physical Exam with Visual Pedagogy and Structure

    Control: Physical Exam without Visual Pedagogy and Structure

    Outcomes

    Primary Outcome Measures

    Change from baseline on the Aberrant Behavior Checklist-Community measure ( irritability and stereotypy subscales)
    Caregiver report form of subjects' behaviors.

    Secondary Outcome Measures

    Number of study exam items completed during study exams
    Study medical personnel teams (nurse and medical resident) tallied number of total exam items completed during study exams with each participant
    Change from baseline in Cooperation likert-scale rating form
    Caregiver report form of subjects' cooperation behaviors during study physical exams.

    Full Information

    First Posted
    July 13, 2017
    Last Updated
    July 25, 2017
    Sponsor
    University of Colorado, Denver
    Collaborators
    Children's Hospital Colorado
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03232775
    Brief Title
    Use of a Visual Pedagogy and Structure With Children With Autism for Routine Physical Exams
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2007 (Actual)
    Primary Completion Date
    August 2011 (Actual)
    Study Completion Date
    August 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver
    Collaborators
    Children's Hospital Colorado

    4. Oversight

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

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder
    Keywords
    visual pedagogy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Masking Description
    The medical examination teams (one chief medical resident and one nurse) will be blind to the study aim.
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Other
    Arm Description
    Treatment: Physical Exam with Visual Pedagogy and Structure
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    Control: Physical Exam without Visual Pedagogy and Structure
    Intervention Type
    Other
    Intervention Name(s)
    Treatment: Physical Exam with Visual Pedagogy and Structure
    Intervention Description
    Routine physical examination participants receive visual pedagogy and reinforcement (preferred food treat).
    Intervention Type
    Other
    Intervention Name(s)
    Control: Physical Exam without Visual Pedagogy and Structure
    Intervention Description
    Participants engage in routine physical examination without visual pedagogy and reinforcement (preferred food treat).
    Primary Outcome Measure Information:
    Title
    Change from baseline on the Aberrant Behavior Checklist-Community measure ( irritability and stereotypy subscales)
    Description
    Caregiver report form of subjects' behaviors.
    Time Frame
    The end of the 15-minute waiting period and within 15 minutes after the completion of physical exam
    Secondary Outcome Measure Information:
    Title
    Number of study exam items completed during study exams
    Description
    Study medical personnel teams (nurse and medical resident) tallied number of total exam items completed during study exams with each participant
    Time Frame
    Within 15 minutes after conclusion of each participant's study exam.
    Title
    Change from baseline in Cooperation likert-scale rating form
    Description
    Caregiver report form of subjects' cooperation behaviors during study physical exams.
    Time Frame
    At study entry and within 15 minutes after the completion of study physical exams

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronological ages 4 to 10 years. Presumptive diagnosis of Autistic Disorder or Asperger's Disorder prior to study admission from a psychologist or psychiatrist experienced with children who have autism. Meets research criteria for Autistic Spectrum Disorder: Meets cut-off scores for autism spectrum on the Social Communication Questionnaire (SCQ) (cut-off = 15) and Meets empirically-derived algorithm cut-off scores for Autism Spectrum Disorders on the Autism Diagnostic Observation Schedule (ADOS). All subjects will have the ADOS administered by a clinician trained in research reliability standards. The Principal Investigator, a certified ADOS trainer and research reliable, or trained designee under the supervision of the Principal Investigator, will administer the ADOS. Participants will represent the typical DSM-IV diagnostic developmental profile of children on the autism spectrum and no neurological injuries or illnesses before the age of three years that could account for their symptoms (i.e., meningitis, encephalitis, severe head injury or seizure disorder). A Communication standard score ≤ 85, as measured by the Vineland Adaptive Behavior Scales - II. a) The VABS-II will be administered by the Principal Investigator or trained designee under the supervision of the Principal Investigator as part of the initial phone screening process. Children with an ASD, particularly school-aged children and adolescents, may present with myriad prescribed psychotropic medications. Therefore, we will not exclude children on a variety of psychotropic medications; rather we will conduct a qualitative analysis to look at this issue. No restrictions regarding race or gender will be applied to the autism or developmental disability sample. Every effort will be made not to over-represent any particular race and/or gender group. Physically healthy prior to physical exam. Previous exposure to visual systems. This will be assessed based on caregiver report during the phone screening using one question relating to the use of visual structure with the child. History of: Poor Cooperation Completely Uncooperative Physical exams rated by caregiver on 4-point scale of cooperation modified from Forsberg et al. [56]. 0 = No problems with cooperation; 1 = Minor problems with cooperation: Child shows mild behavior problems and/or anxiety symptoms; 2 = Poor cooperation: Child's behavior problems and/or anxiety symptoms requires that the medical staff have to spend extra time and effort to manage the child and complete the exam; 3 = Completely uncooperative: Exam is not possible due to child's behavior problems and/or anxiety symptoms Exclusion Criteria: Participants with intelligence quotient standard scores > 40. Presence of the following genetic or progressive neurological disorders known to be causative of or potentially resulting in a phenotype similar to autism: Fragile X, Landau Kleffner, Rett Disorder, Childhood Disintegrative Disorder, or Tuberous Sclerosis, based on screening by clinical staff and subsequent review by medical staff as needed Presence of vision or hearing loss or significant motor impairments. Wards of the State.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robin Gabriels, PsyD
    Organizational Affiliation
    University of Colorado, Denver
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Use of a Visual Pedagogy and Structure With Children With Autism for Routine Physical Exams

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