iPad Application to Treat Prosodic Deficits in Students With Communication Disorders

Autism Clinical Trial

Official title:

Handheld Technology for Speech Development in Students With Autism Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917864
• Other study ID #: 1306012259
• Secondary ID: ED-IES-13-R-0005
• Status: Completed
• Phase: N/A
• First received: August 5, 2013
• Last updated: June 13, 2016
• Start date: July 2013
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the utility of a specialized iPad application designed to treat difficulties with intonation (e.g., melody in voice) in children with autism spectrum disorders (ASD) and other communication disorders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• SLPs, in Connecticut Public Schools, who provide intervention to students with autism spectrum disorders and related disorders

• Students, ages 4-18, who attend school in Connecticut and demonstrate prosodic difficulties secondary to a diagnosis of ASD, apraxia of speech, or other communication disorder

Exclusion Criteria:

• Students with concomitant genetic disorders

Study Design

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

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Communication Disorders

Intervention

Behavioral:
• iPad Application
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	Effectiveness of software	The effectiveness of the software will be measured in two ways.; Perceptual ratings of prosody. Pre- and post-treatment speech samples will be collected from each student participant. These samples will be rated by a member of the research staff on the following prosodic characteristics: rate, rhythm, stress, volume.; Questionnaires. Questionnaires will be completed pre- and post-treatment by the students' classroom teacher and speech-language pathologist. These questionnaires will measure the students' use and generalization of skills taught during the intervention.	12 months	No
Secondary	Usability of software	Usability of software will be measured through questionnaires completed by the speech-language pathologists. Questionnaires will measure ease of software use, utility of software functions, and student engagement during intervention sessions.	12 months	No
Secondary	Student engagement in treatment	Student engagement will be evaluated indirectly by rating scales completed by the speech-language pathologist. Likert scales will be used to quantify student engagement on the following parameters: time engaged in on-task behavior, time engaged in off-task behavior, perceived enjoyment of software.	12 months	No
Secondary	Improvement in peer acceptance	Changes in peer acceptance will be evaluated using two different methodologies.; Classroom teacher questionnaire. Each student's classroom teacher will complete a questionnaire pre- and post-treatment measuring the student's interaction with classroom peers.; Semi-structured observation. A member of the research staff will observe each student pre- and post-treatment and complete frequency tallies on the number of peer interactions initiated during a 15-minute semi-structured activity.	12 months	No