Back to resultsiPad Application to Treat Prosodic Deficits in Students With Communication Disorders
Primary Purpose
Autism, Communication Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iPad Application
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Autism, Autism Spectrum Disorders, Prosody, Speech treatment
Eligibility 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
Sites / Locations
- Yale Child Study Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iPad Application
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT01917864
First Posted
August 5, 2013
Last Updated
June 13, 2016
Sponsor
Yale University
Collaborators
Handhold Adaptive
1. Study Identification
Unique Protocol Identification Number
NCT01917864
Brief Title
iPad Application to Treat Prosodic Deficits in Students With Communication Disorders
Official Title
Handheld Technology for Speech Development in Students With Autism Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Handhold Adaptive
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Communication Disorders
Keywords
Autism, Autism Spectrum Disorders, Prosody, Speech treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iPad Application
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
iPad Application
Intervention 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.
Primary Outcome Measure Information:
Title
Effectiveness of software
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Usability of software
Description
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.
Time Frame
12 months
Title
Student engagement in treatment
Description
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.
Time Frame
12 months
Title
Improvement in peer acceptance
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick Shic, Ph.D
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Learn more about this trial
iPad Application to Treat Prosodic Deficits in Students With Communication Disorders
We'll reach out to this number within 24 hrs