NCT01917864

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration 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

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

2.8 years

First QC Date

August 5, 2013

Last Update Submit

June 13, 2016

Conditions

Keywords

AutismAutism Spectrum DisordersProsodySpeech treatment

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of software

    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.

    12 months

Secondary Outcomes (3)

  • Usability of software

    12 months

  • Student engagement in treatment

    12 months

  • Improvement in peer acceptance

    12 months

Study Arms (1)

iPad Application

EXPERIMENTAL

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

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 Application

Eligibility Criteria

Age4 Years - 18 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 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

You may not qualify if:

  • Students with concomitant 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

Autistic DisorderCommunication DisordersAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

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
SPONSOR

Study Record Dates

First Submitted

August 5, 2013

First Posted

August 7, 2013

Study Start

July 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations