Handheld Technology for Speech Development in Students With Autism

Autism Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780090
• Other study ID #: 1208010627
• Secondary ID: ED-IES-12-R-0007
• Status: Completed
• Phase: N/A
• First received: January 28, 2013
• Last updated: January 28, 2013
• Start date: September 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 19 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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.

Locations

Country	Name	City	State
United States	Yale Child Study Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Handhold Adaptive, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months	No
Primary	Usability of software	Assessment of Outcome: SLPs will complete satisfaction surveys and attend a focus group to obtain information regarding software usability.	3 months	No
Secondary	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.	3 months	No
Secondary	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.	3 months	No