Using a Voice Output Communication Aid to Facilitate Lang... | NCT01816178

Studies
Using a Voice Output Communication Aid to Facilitate Language Development in Young Children With ASD

NCT01816178

Sponsor

University of South Alabama

Status

Completed

Last Update Posted

Mar 22, 2013Estimated

Enrollment

5Actual

Phase

Not Applicable

Conditions

Autistic Disorder

Interventions

communication training

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

Mar 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

Feb 2004

Primary Completion Date

Aug 2005Actual

Completion Date

Aug 2005Actual

First Submitted Date

Mar 11, 2013

First Submission Date that Met QC Criteria

Mar 21, 2013

First Posted Date

Mar 22, 2013Estimated

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

Mar 21, 2013

Last Update Posted Date

Mar 22, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

It was proposed that in order to teach these children to use a Voice Output Communication Aid (VOCA), it should be introduced through a play-based situation using parents as the primary interventionist.

Detailed Description

The research will test the effectiveness of using the communication board to improve the frequency of communication and social engagement for these children, and the level or sophistication of that engagement. The study will test the effectiveness of using the communication board in a variety of settings and a variety of practitioners. The study will have sites in and near Jonesboro, Arkansas.

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

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
communication training	Experimental	Participants were instructed in the use of a voices output communication aid.	Behavioral: communication training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
communication training	Behavioral	Participants were instructed in the use of a voices output communication aid.	communication training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improved Communication	Surveys of number of words Text data from VOCA Formal assessment instruments	1 year

Secondary Outcomes

Measure	Description	Time Frame
Review of text output from the VOCA	The VOCA records data on usage by day and time. We analyze the text data from the VOCA.	1 year

Other Outcomes

Measure	Description	Time Frame
Improved parent interaction	Data were gathered from the parents on the number of words spoken by their son and the way they "felt" the intervention was proceeding. Essentially we had parents report on the effectiveness of using the VOCA to improve the frequency of communication and social engagement for these young children with ASD.	1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Criteria for inclusion included a diagnosis of autism and agreement of the parents to participate and use the VOCA at home.

Exclusion Criteria:

Not diagnosed with Autism Spectrum disorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas State University		State University	Arkansas	72401	United States

Condition Browse Module

MeSH Terms

ID	Term
D001321	Autistic Disorder
D000067877	Autism Spectrum Disorder

Ancestor Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided