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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


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
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