Clinical trial NCT01655485: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: child anxiety
challenging behaviors
time
Parent anxiety
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Marquette University
First posted: 2012-08-02
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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. 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: 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).

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.

Primary outcomes:
measure: Child behaviors
timeFrame: up to 2 hours
Secondary outcomes:
measure: Parent anxiety
timeFrame: Baseline
Other outcomes:
measure: Child anxiety
timeFrame: Baseline
measure: Change in parent anxiety
timeFrame: Change from baseline in state anxiety measure to 30 minutes later
measure: Change in child anxiety
timeFrame: change in child anxiety from baseline to 30 minutes later
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Children's Hospital and Health System Foundation, Wisconsin
name: Norah L Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: