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Handheld Technology for Speech Development in Students With Autism

This study has been completed.
Sponsor:
Collaborator:
Handhold Adaptive, LLC
Information provided by (Responsible Party):
Frederick Shic, Yale University
ClinicalTrials.gov Identifier:
NCT01780090
First received: January 28, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

The proposed study will result in a software application compatible with the Apple iPad, iPhone and iPod Touch (hereafter termed "iOS devices") which addresses several aspects of prosodic deficits common in speakers with Autism Spectrum Disorders (ASDs) and other communication disorders, using a developmentally appropriate, intuitive interface that requires little technical skill and which can be managed by educators and parents. The program will contain elements that aid in tracking and maintaining individual student progress records, and will be designed for use in the classroom, at home, and in other environments. This study's intended focus is on the feasibility and usability of the software application.


Condition Intervention
Autism Spectrum Disorders
 Other: iPad software

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Handheld Technology for Speech Development in Students With Autism Spectrum Disorders (ASDs)

Resource links provided by NLM:

MedlinePlus related topics: Autism
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Learning of software [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    Assessment of Outcome:

    Each speech-language pathologist (SLP) will complete a software training then take a post-training online assessment measuring software competency.


  • Usability of software [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    Assessment of Outcome:

    SLPs will complete satisfaction surveys and attend a focus group to obtain information regarding software usability.



Secondary Outcome Measures:
  • Student engagement in treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    Assessment of Outcome:

    SLPs will rate the student's engagement using a rating scale after each treatment session with the iPad and software.


  • Software effectiveness [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    Assessment of Outcome:

    SLPs will rate student participants' prosody before and after iPad treatment using a specialized rubric to measure changes in speech production.



Enrollment: 40
Study Start Date: September 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: iPad software
Student participants will use specialized, iPad software under the direction of the SLP, 1 time a week over the course of 2 months.
 Other: iPad software
A specialized iPad application, entitled SpeechPrompts, has been developed to treat prosodic difficulties commonly seen in ASDs. SpeechPrompts provides the SLPs that work with students with ASDs an additional tool to treat prosody. The SpeechPrompts software offers visual support and biofeedback to change prosody. These two tools are not typically available for school-based SLPs.

  Eligibility

Ages Eligible for Study:   4 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • SLPs, in Connecticut Public Schools, who provide intervention to students with autism spectrum disorders.
  • Students, ages 4 - 19, who attend school in Connecticut and demonstrate prosodic difficulties secondary to a diagnosis of ASD.

Exclusion Criteria:

  • Students with concommitant genetic disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780090

Locations
United States, Connecticut
Yale Child Study Center
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Handhold Adaptive, LLC
Investigators
Principal Investigator: Frederick Shic, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Frederick Shic, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT01780090     History of Changes
Other Study ID Numbers: 1208010627, ED-IES-12-R-0007
Study First Received: January 28, 2013
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
autism
prosody
speech
autism spectrum disorder

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013