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

NCT ID: NCT01655485

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-07-31

Brief Summary

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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 ).

Detailed Description

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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).

Conditions

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Anxiety

Keywords

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child anxiety challenging behaviors time Parent anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Patient teaching

ipad application for social script book

Group Type EXPERIMENTAL

Patient teaching

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Going to Imaging ipad application

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marquette University

OTHER

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Norah L. Johnson

Assistant Profesor Marquette University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Norah L Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital and Health System Foundation, Wisconsin

Locations

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Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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255769-1

Identifier Type: -

Identifier Source: org_study_id