- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01917864
iPad Application to Treat Prosodic Deficits in Students With Communication Disorders
June 13, 2016 updated by: Yale University
Handheld Technology for Speech Development in Students With Autism Spectrum Disorders
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale Child Study Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: iPad Application
Student participants will use specialized iPad software under the supervision of a speech-language pathologist over the course of 12 months, approximately one session per week, one hour per session.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness of software
Time Frame: 12 months
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The effectiveness of the software will be measured in two ways.
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability of software
Time Frame: 12 months
|
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.
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12 months
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Student engagement in treatment
Time Frame: 12 months
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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.
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12 months
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Improvement in peer acceptance
Time Frame: 12 months
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Changes in peer acceptance will be evaluated using two different methodologies.
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Frederick Shic, Ph.D, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
August 5, 2013
First Submitted That Met QC Criteria
August 5, 2013
First Posted (Estimate)
August 7, 2013
Study Record Updates
Last Update Posted (Estimate)
June 14, 2016
Last Update Submitted That Met QC Criteria
June 13, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1306012259
- ED-IES-13-R-0005 (Other Grant/Funding Number: Department of Education)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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