iPad Application to Treat Prosodic Deficits in Students With Communication Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01917864
Recruitment Status : Completed
First Posted : August 7, 2013
Last Update Posted : June 14, 2016
Handhold Adaptive, LLC
Information provided by (Responsible Party):
Yale University

Brief 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.

Condition or disease Intervention/treatment Phase
Autism Communication Disorders Behavioral: iPad Application Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Handheld Technology for Speech Development in Students With Autism Spectrum Disorders
Study Start Date : July 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.
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.

Primary Outcome Measures :
  1. Effectiveness of software [ Time Frame: 12 months ]

    The effectiveness of the software will be measured in two ways.

    1. 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.
    2. 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.

Secondary Outcome Measures :
  1. 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.

  2. Student engagement in treatment [ Time Frame: 12 months ]
    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.

  3. Improvement in peer acceptance [ Time Frame: 12 months ]

    Changes in peer acceptance will be evaluated using two different methodologies.

    1. Classroom teacher questionnaire. Each student's classroom teacher will complete a questionnaire pre- and post-treatment measuring the student's interaction with classroom peers.
    2. 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.

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01917864

United States, Connecticut
Yale Child Study Center
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Handhold Adaptive, LLC
Principal Investigator: Frederick Shic, Ph.D Yale University

Responsible Party: Yale University Identifier: NCT01917864     History of Changes
Other Study ID Numbers: 1306012259
ED-IES-13-R-0005 ( Other Grant/Funding Number: Department of Education )
First Posted: August 7, 2013    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016

Keywords provided by Yale University:
Autism Spectrum Disorders
Speech treatment

Additional relevant MeSH terms:
Communication Disorders
Autistic Disorder
Autism Spectrum Disorder
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms