Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder
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|ClinicalTrials.gov Identifier: NCT01655485|
Recruitment Status : Completed
First Posted : August 2, 2012
Last Update Posted : August 7, 2013
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.
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 ).
|Condition or disease||Intervention/treatment||Phase|
|Anxiety||Other: Patient teaching||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder(ASD) Undergoing Medical Imaging Procedures|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
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
- Child behaviors [ Time Frame: up to 2 hours ]Child behaviors measured during imaging procedures with the behaviors observation tool created for this study.
- Parent anxiety [ Time Frame: Baseline ]State anxiety measure www.mindgarden.com
- Child anxiety [ Time Frame: Baseline ]Vital signs
- Change in parent anxiety [ Time Frame: Change from baseline in state anxiety measure to 30 minutes later ]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 ]Child anxiety is measured at baseline vital signs and again after the intervention to see if there is a change.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655485
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53201|
|Principal Investigator:||Norah L Johnson, PhD||Children's Hospital and Health System Foundation, Wisconsin|