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

NCT03232775 | Completed

• 1 other identifier: 07-0362
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autism Spectrum Disorder

Keywords

visual pedagogy

Outcome Measures

Primary Outcomes (1)

• Change from baseline on the Aberrant Behavior Checklist-Community measure ( irritability and stereotypy subscales)

  Caregiver report form of subjects' behaviors.

  The end of the 15-minute waiting period and within 15 minutes after the completion of physical exam

Secondary Outcomes (2)

• Number of study exam items completed during study exams

  Within 15 minutes after conclusion of each participant's study exam.

• Change from baseline in Cooperation likert-scale rating form

  At study entry and within 15 minutes after the completion of study physical exams

Study Arms (2)

Treatment

OTHER

Treatment: Physical Exam with Visual Pedagogy and Structure

Other: Treatment: Physical Exam with Visual Pedagogy and Structure

Control

OTHER

Control: Physical Exam without Visual Pedagogy and Structure

Other: Control: Physical Exam without Visual Pedagogy and Structure

Interventions

Treatment: Physical Exam with Visual Pedagogy and Structure OTHER

Routine physical examination participants receive visual pedagogy and reinforcement (preferred food treat).

Treatment

Control: Physical Exam without Visual Pedagogy and Structure OTHER

Participants engage in routine physical examination without visual pedagogy and reinforcement (preferred food treat).

Control

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Children's Hospital Colorado: collaborator

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Robin Gabriels, PsyD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The medical examination teams (one chief medical resident and one nurse) will be blind to the study aim.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 28, 2017
• Study Start: September 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: July 28, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share