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Handheld Technology for Speech Development in Students With Autism

Primary Purpose

Autism Spectrum Disorders

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

iPad software

About this trial

This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring autism, prosody, speech, autism spectrum disorder

Eligibility Criteria

4 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale Child Study Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

iPad software

Arm Description

Student participants will use specialized, iPad software under the direction of the SLP, 1 time a week over the course of 2 months.

Outcomes

Primary Outcome Measures

Learning of software

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

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

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

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

Full Information

NCT ID

NCT01780090

First Posted

January 28, 2013

Last Updated

January 28, 2013

Sponsor

Yale University

Collaborators

Handhold Adaptive

1. Study Identification

Unique Protocol Identification Number

NCT01780090

Brief Title

Handheld Technology for Speech Development in Students With Autism

Official Title

Handheld Technology for Speech Development in Students With Autism Spectrum Disorders (ASDs)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yale University

Collaborators

Handhold Adaptive

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorders

Keywords

autism, prosody, speech, autism spectrum disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

iPad software

Arm Type

Experimental

Arm Description

Student participants will use specialized, iPad software under the direction of the SLP, 1 time a week over the course of 2 months.

Intervention Type

Other

Intervention Name(s)

iPad software

Intervention Description

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.

Primary Outcome Measure Information:

Title

Learning of software

Description

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

Time Frame

3 months

Title

Usability of software

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Student engagement in treatment

Description

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

Time Frame

3 months

Title

Software effectiveness

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederick Shic, Ph.D.

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale Child Study Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Handheld Technology for Speech Development in Students With Autism

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