New Haven, Connecticut 06510

  • Autism Spectrum Disorders

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.


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


Study is Available At:


Original ID:

1208010627


NCT ID:

NCT01780090


Secondary ID:

ED-IES-12-R-0007


Study Acronym:


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)


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

4 Years


Maximum Age:

19 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Yale University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Mask


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Actual


Overall Contact Information

Official Name:Frederick Shic, Ph.D.
Principal Investigator
Yale University

Study Dates

Start Date:September 2012
Completion Date:January 2013
Completion Type:Actual
Primary Completion Date:December 2012
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 28, 2013
First Received Date:January 28, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Software effectiveness
Time Frame:3 months
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Student engagement in treatment
Time Frame:3 months
Safety Issues:False
Description:Assessment of Outcome: SLPs will rate the student's engagement using a rating scale after each treatment session with the iPad and software.
Outcome Type:Primary Outcome
Measure:Usability of software
Time Frame:3 months
Safety Issues:False
Description:Assessment of Outcome: SLPs will complete satisfaction surveys and attend a focus group to obtain information regarding software usability.
Outcome Type:Primary Outcome
Measure:Learning of software
Time Frame:3 months
Safety Issues:False
Description:Assessment of Outcome: Each speech-language pathologist (SLP) will complete a software training then take a post-training online assessment measuring software competency.

Study Interventions

Intervention Type:Other
Name:iPad software
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.
Arm Name:iPad software

Study Arms

Study Arm Type:Experimental
Arm Name:iPad software
Description:Student participants will use specialized, iPad software under the direction of the SLP, 1 time a week over the course of 2 months.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Yale University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Handhold Adaptive, LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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