NCT01780090

Brief Summary

The proposed study will result in a software application compatible with the Apple iPad, iPhone and iPod Touch (hereafter termed "iOS devices") which addresses several aspects of prosodic deficits common in speakers with Autism Spectrum Disorders (ASDs) and other communication disorders, using a developmentally appropriate, intuitive interface that requires little technical skill and which can be managed by educators and parents. The program will contain elements that aid in tracking and maintaining individual student progress records, and will be designed for use in the classroom, at home, and in other environments. This study's intended focus is on the feasibility and usability of the software application.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
Last Updated

January 30, 2013

Status Verified

January 1, 2013

Enrollment Period

3 months

First QC Date

January 28, 2013

Last Update Submit

January 28, 2013

Conditions

Keywords

autismprosodyspeechautism spectrum disorder

Outcome Measures

Primary Outcomes (2)

  • Learning of software

    Assessment of Outcome: Each speech-language pathologist (SLP) will complete a software training then take a post-training online assessment measuring software competency.

    3 months

  • Usability of software

    Assessment of Outcome: SLPs will complete satisfaction surveys and attend a focus group to obtain information regarding software usability.

    3 months

Secondary Outcomes (2)

  • Student engagement in treatment

    3 months

  • Software effectiveness

    3 months

Study Arms (1)

iPad software

EXPERIMENTAL

Student participants will use specialized, iPad software under the direction of the SLP, 1 time a week over the course of 2 months.

Other: iPad software

Interventions

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.

iPad software

Eligibility Criteria

Age4 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • SLPs, in Connecticut Public Schools, who provide intervention to students with autism spectrum disorders.
  • Students, ages 4 - 19, who attend school in Connecticut and demonstrate prosodic difficulties secondary to a diagnosis of ASD.

You may not qualify if:

  • Students with concommitant genetic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderSpeech

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersVerbal BehaviorCommunicationBehavior

Study Officials

  • Frederick Shic, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 28, 2013

First Posted

January 30, 2013

Study Start

September 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

January 30, 2013

Record last verified: 2013-01

Locations