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

This study is currently recruiting participants.

Verified July 2012 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: July 30, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 11, 2011

Last Updated Date

July 30, 2012

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01655485 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Parent anxiety [ Time Frame: Baseline ] [ Designated as safety issue: No ]

State anxiety measure www.mindgarden.com

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

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.

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder(ASD) Undergoing Medical Imaging Procedures

Brief Summary

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:

Lower anxiety as measured by heart rate respiratory rate, and blood pressure.
Exhibit fewer challenging behaviors as measured by a behavior observation scale (developed for the study.
Higher procedure completion rate.
Shorter time to complete a procedure.
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:
Lower state anxiety as measured by the State Anxiety Inventory.

Detailed Description

This is a cross sectional study. Parent state anxiety is measured with the 20-item State anxiety measure from www.mindgarden.com. Child anxiety is measured with vital signs (heart rate, blood pressure, respiratory rate). Behaviors will be observed and recorded on the behavior observation tool.

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Anxiety

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Patient teaching

ipad application for social script book

Intervention: Other: Patient teaching

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

4 Years to 16 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Norah Johnson, PhD

4142883857

njohnson@chw.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01655485

Other Study ID Numbers ^ICMJE

255769-1

Has Data Monitoring Committee

Yes

Responsible Party

Norah L. Johnson, Medical College of Wisconsin

Study Sponsor ^ICMJE

Medical College of Wisconsin

Collaborators ^ICMJE

Marquette University

Investigators ^ICMJE

Principal Investigator:

Norah L Johnson, PhD

Children's Hospital and Health System Foundation, Wisconsin

Information Provided By

Medical College of Wisconsin

Verification Date

July 2012

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

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