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Completed

NCT Number: NCT01655485

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

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 ).

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Going to Imaging ipad application

Primary outcomes

  1. Child behaviors

    Time frame: up to 2 hours

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

Secondary outcomes

  1. Parent anxiety

    Time frame: Baseline

    State anxiety measure www.mindgarden.com

Other outcomes

  1. Child anxiety

    Time frame: Baseline

    Vital signs

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Marquette University

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 2, 2012
Registry last updated
Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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