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iPad Application to Treat Prosodic Deficits in Students With Communication Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Collaborator:
Handhold Adaptive, LLC
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01917864
First received: August 5, 2013
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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 Intervention
Autism
Communication Disorders
Behavioral: iPad Application

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Handheld Technology for Speech Development in Students With Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Effectiveness of software [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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:
  • Usability of software [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Student engagement in treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Improvement in peer acceptance [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 200
Study Start Date: July 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917864

Contacts
Contact: Carla A Wall, B.A. (203) 737-1121 carla.wall@yale.edu

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

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01917864     History of Changes
Other Study ID Numbers: 1306012259, ED-IES-13-R-0005
Study First Received: August 5, 2013
Last Updated: June 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Autism
Autism Spectrum Disorders
Prosody
Speech treatment

Additional relevant MeSH terms:
Communication Disorders
Disease
Autistic Disorder
Pathologic Processes
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 15, 2014