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 ).

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Other: Patient teaching

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).

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53201
      • Children's Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Going to Imaging ipad application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child behaviors	Child behaviors measured during imaging procedures with the behaviors observation tool created for this study.	up to 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent anxiety	State anxiety measure www.mindgarden.com	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child anxiety	Vital signs	Baseline
Change in parent anxiety	Parent anxiety is measured at baseline www.mindgarden.com and again after the intervention to see if there is a change.	Change from baseline in state anxiety measure to 30 minutes later
Change in child anxiety	Child anxiety is measured at baseline vital signs and again after the intervention to see if there is a change.	change in child anxiety from baseline to 30 minutes later

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Marquette University
• Investigators: Principal Investigator: Norah L Johnson, PhD, Children's Hospital and Health System Foundation, Wisconsin

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: October 11, 2011
• First Submitted That Met QC Criteria: July 30, 2012
• First Posted (Estimate): August 2, 2012

Study Record Updates

• Last Update Posted (Estimate): August 7, 2013
• Last Update Submitted That Met QC Criteria: August 6, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: time; challenging behaviors; child anxiety; Parent anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 255769-1