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Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder

This study has been completed.
Sponsor:
Collaborator:
Marquette University
Information provided by (Responsible Party):
Norah L. Johnson, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01655485
First received: October 11, 2011
Last updated: August 6, 2013
Last verified: August 2013

October 11, 2011
August 6, 2013
October 2011
July 2013   (final data collection date for primary outcome measure)
Child behaviors [ Time Frame: up to 2 hours ] [ Designated as safety issue: Yes ]
Child behaviors measured during imaging procedures with the behaviors observation tool created for this study.
Same as current
Complete list of historical versions of study NCT01655485 on ClinicalTrials.gov Archive Site
Parent anxiety [ Time Frame: Baseline ] [ Designated as safety issue: No ]
State anxiety measure www.mindgarden.com
Same as current
  • Child anxiety [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Vital signs
  • Change in parent anxiety [ Time Frame: Change from baseline in state anxiety measure to 30 minutes later ] [ Designated as safety issue: No ]
    Parent anxiety is measured at baseline www.mindgarden.com and again after the intervention to see if there is a change.
  • Change in child anxiety [ Time Frame: change in child anxiety from baseline to 30 minutes later ] [ Designated as safety issue: No ]
    Child anxiety is measured at baseline vital signs and again after the intervention to see if there is a change.
Same as current
 
Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder
Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder(ASD) Undergoing Medical Imaging Procedures

The purpose of the research is to test the effectiveness of the social story intervention delivered using the iPAD application "Going to Imaging" on the anxiety, challenging child behaviors, child injuries and completion rates among children with ASD undergoing medical imaging procedures. A secondary purpose is to test the effect of this intervention on the anxiety levels of the parents of ASD children undergoing medical imaging procedures.

Hypotheses:

H1: Children with ASD who are exposed to a story book "Here the investigators go to medical imaging (x-ray)" to prepare for medical imaging compared with children with ASD exposed to treatment as usual (TAU) will have:

  1. Lower anxiety as measured by heart rate respiratory rate, and blood pressure (baseline compared to up to two hours later).
  2. Exhibit fewer challenging behaviors as measured by a behavior observation scale (developed for the study (up to 2 hours after baseline)
  3. Higher procedure completion rate.
  4. Shorter time to complete a procedure.
  5. Less child injuries.

    H2: Compared to parents of ASD children exposed to treatment as usual (TAU), parents of children with ASD who are exposed to a story book "Here the investigators go to medical imaging (x-ray)" to prepare for medical imaging will have:

  6. Lower state anxiety as measured by the State Anxiety Inventory ( baseline ).

Parent state anxiety is measured at baseline with the 20-item State anxiety measure from www.mindgarden.com. Child anxiety is measured at baseline with vital signs (heart rate, blood pressure, respiratory rate). Behaviors will be observed and recorded on the behavior observation tool up to 2 hours after the baseline measure (during the imaging).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Anxiety
Other: Patient teaching
The Social script application is an story book on the iPAD with photos and script explaining the steps of getting a medical image such as a CAT scan from the perspective of the child.
Other Name: Going to Imaging ipad application
Experimental: Patient teaching
ipad application for social script book
Intervention: Other: Patient teaching
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children with autism spectrum disorder
  • English speaking parent or guardian.

Exclusion Criteria:

  • Non-english speaking parent or guardian
  • Severe autism as defined by caregiver or health care provider.
Both
4 Years to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01655485
255769-1
Yes
Norah L. Johnson, Medical College of Wisconsin
Medical College of Wisconsin
Marquette University
Principal Investigator: Norah L Johnson, PhD Children's Hospital and Health System Foundation, Wisconsin
Medical College of Wisconsin
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP