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

NCT01655485 | Completed DMC

• 1 other identifier: 255769-1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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:

1. 1.Lower anxiety as measured by heart rate respiratory rate, and blood pressure (baseline compared to up to two hours later).
2. 2.Exhibit fewer challenging behaviors as measured by a behavior observation scale (developed for the study (up to 2 hours after baseline)
3. 3.Higher procedure completion rate.
4. 4.Shorter time to complete a procedure.
5. 5.Less child injuries.
6. 6.Lower state anxiety as measured by the State Anxiety Inventory ( baseline ).

Conditions

Anxiety

Keywords

child anxiety; challenging behaviors; time; Parent anxiety

Outcome Measures

Primary Outcomes (1)

• Child behaviors

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

  up to 2 hours

Secondary Outcomes (1)

• Parent anxiety

  Baseline

Other Outcomes (3)

• Child anxiety

  Baseline

• Change in parent anxiety

  Change from baseline in state anxiety measure to 30 minutes later

• Change in child anxiety

  change in child anxiety from baseline to 30 minutes later

Study Arms (1)

Patient teaching

EXPERIMENTAL

ipad application for social script book

Other: Patient teaching

Interventions

Patient teaching 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.

Also known as: Going to Imaging ipad application

Patient teaching

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children with autism spectrum disorder
• English speaking parent or guardian.

You may not qualify if:

• Non-english speaking parent or guardian
• Severe autism as defined by caregiver or health care provider.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Marquette University: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Norah L Johnson, PhD

  Children's Hospital and Health System Foundation, Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Profesor Marquette University

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: August 2, 2012
• Study Start: October 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

US (1)