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

This study is currently recruiting participants.
Verified February 2013 by Medical College of Wisconsin
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: February 13, 2013
Last verified: February 2013
History of Changes
  Purpose

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 ).

Condition Intervention
Anxiety
 Other: Patient teaching

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder(ASD) Undergoing Medical Imaging Procedures

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Autism
U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Parent anxiety [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    State anxiety measure www.mindgarden.com


Other Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient teaching
ipad application for social script book
 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

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655485

Contacts
Contact: Norah Johnson, PhD 4142883857 njohnson@chw.org

Locations
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53201
Contact: Norah Johnson, PhD     414-288-3857     njohnson@chw.org    
Principal Investigator: Norah L Johnson, PhD            
Sponsors and Collaborators
Medical College of Wisconsin
Marquette University
Investigators
Principal Investigator: Norah L Johnson, PhD Children's Hospital and Health System Foundation, Wisconsin
  More Information

No publications provided

Responsible Party: Norah L. Johnson, Assistant Profesor Marquette University, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01655485     History of Changes
Other Study ID Numbers: 255769-1
Study First Received: October 11, 2011
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
child anxiety
challenging behaviors
time
Parent anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on May 16, 2013