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

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient teaching
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring child anxiety, challenging behaviors, time, Parent anxiety

Eligibility Criteria

4 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient teaching

Arm Description

ipad application for social script book

Outcomes

Primary Outcome Measures

Child behaviors
Child behaviors measured during imaging procedures with the behaviors observation tool created for this study.

Secondary Outcome Measures

Parent anxiety
State anxiety measure www.mindgarden.com

Full Information

First Posted
October 11, 2011
Last Updated
August 6, 2013
Sponsor
Medical College of Wisconsin
Collaborators
Marquette University
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1. Study Identification

Unique Protocol Identification Number
NCT01655485
Brief Title
Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder
Official Title
Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder(ASD) Undergoing Medical Imaging Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Marquette University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 (baseline compared to up to two hours later). Exhibit fewer challenging behaviors as measured by a behavior observation scale (developed for the study (up to 2 hours after baseline) 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 ( baseline ).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
child anxiety, challenging behaviors, time, Parent anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient teaching
Arm Type
Experimental
Arm Description
ipad application for social script book
Intervention Type
Other
Intervention Name(s)
Patient teaching
Other Intervention Name(s)
Going to Imaging ipad application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child behaviors
Description
Child behaviors measured during imaging procedures with the behaviors observation tool created for this study.
Time Frame
up to 2 hours
Secondary Outcome Measure Information:
Title
Parent anxiety
Description
State anxiety measure www.mindgarden.com
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Child anxiety
Description
Vital signs
Time Frame
Baseline
Title
Change in parent anxiety
Description
Parent anxiety is measured at baseline www.mindgarden.com and again after the intervention to see if there is a change.
Time Frame
Change from baseline in state anxiety measure to 30 minutes later
Title
Change in child anxiety
Description
Child anxiety is measured at baseline vital signs and again after the intervention to see if there is a change.
Time Frame
change in child anxiety from baseline to 30 minutes later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norah L Johnson, PhD
Organizational Affiliation
Children's Hospital and Health System Foundation, Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States

12. IPD Sharing Statement

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

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