NCT01816178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

1.5 years

First QC Date

March 11, 2013

Last Update Submit

March 21, 2013

Conditions

Autistic Disorder

Keywords

Autism spectrum DisordersVoice Output Communication

Outcome Measures

Primary Outcomes (1)

  • Improved Communication

    Surveys of number of words Text data from VOCA Formal assessment instruments

    1 year

Secondary Outcomes (1)

  • Review of text output from the VOCA

    1 year

Other Outcomes (1)

  • Improved parent interaction

    1 year

Study Arms (1)

communication training

EXPERIMENTAL

Participants were instructed in the use of a voices output communication aid.

Behavioral: communication training

Interventions

communication trainingBEHAVIORAL

Participants were instructed in the use of a voices output communication aid.

communication training

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • Not diagnosed with Autism Spectrum disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas State University

State University, Arkansas, 72401, United States

Location

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 22, 2013

Study Start

February 1, 2004

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations

US(1)