Effect of a Social Script iPAD Application for Children W... | NCT01655485

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

NCT01655485

Sponsor

Medical College of Wisconsin

Status

Completed

Last Update Posted

Aug 7, 2013Estimated

Enrollment

32Actual

Phase

Not Applicable

Conditions

Anxiety

Interventions

Patient teaching

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Oct 11, 2011

First Submission Date that Met QC Criteria

Jul 30, 2012

First Posted Date

Aug 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2013

Last Update Posted Date

Aug 7, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Norah L. Johnson, Assistant Profesor Marquette University, Medical College of WisconsinPrincipal Investigator

Lead Sponsor

Medical College of WisconsinOTHER

Collaborators

Name	Class
Marquette University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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 ).

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient teaching	Experimental	ipad application for social script book	Other: Patient teaching

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Child behaviors	Child behaviors measured during imaging procedures with the behaviors observation tool created for this study.	up to 2 hours

Secondary Outcomes

Measure	Description	Time Frame
Parent anxiety	State anxiety measure www.mindgarden.com	Baseline

Other Outcomes

Measure	Description	Time Frame
Child anxiety	Vital signs	Baseline
Change in parent anxiety	Parent anxiety is measured at baseline www.mindgarden.com and again after the intervention to see if there is a change.

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Norah L Johnson, PhD	Children's Hospital and Health System Foundation, Wisconsin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Wisconsin		Milwaukee	Wisconsin	53201	United States

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided