Autism Spectrum DisordersNCT01780090
Handheld Technology for Speech Development in Students With Autism
A study testing iPad software in people with Autism Spectrum Disorders, run by Yale University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 19 years
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- iPad software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Students with concommitant genetic disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Child Study Center
New Haven, Connecticut, 06510
About this study
Official title: Handheld Technology for Speech Development in Students With Autism Spectrum Disorders (ASDs)
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.
- Conditions
- Autism Spectrum Disorders
- Being tested
- iPad software
- Keywords
- autism, prosody, speech, autism spectrum disorder
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPad softwareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: iPad software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Usability of software
Assessment of Outcome:
SLPs will complete satisfaction surveys and attend a focus group to obtain information regarding software usability.
Measured: 3 months
Secondary outcomes (2)
Student engagement in treatment
Assessment of Outcome:
SLPs will rate the student's engagement using a rating scale after each treatment session with the iPad and software.
Measured: 3 months
Software effectiveness
Assessment of Outcome:
SLPs will rate student participants' prosody before and after iPad treatment using a specialized rubric to measure changes in speech production.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Handhold Adaptive
- Responsible party
- Principal investigator, Frederick Shic, Yale University
- Investigators
- Frederick Shic, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780090
- Sponsor's protocol ID
- 1208010627
- Other IDs
- ED-IES-12-R-0007
- Status last verified
- Jan 2013
- First submitted
- 28 Jan 2013
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Handheld Technology for Speech Development in Students With Autism Spectrum Disorders (ASDs)
- ClinicalTrials.gov ID
- NCT01780090
- Acronym / sponsor ID
- 1208010627
- Conditions
- Autism Spectrum Disorders
- Keywords
- autism, prosody, speech, autism spectrum disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Handhold Adaptive
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iPad software | Experimental | Other: iPad softwareStudent participants will use specialized, iPad software under the direction of the SLP, 1 time a week over the course of 2 months. |
Who may qualify
- Ages
- 4 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Students with concommitant genetic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPad softwareA 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. | Other | iPad software |
Primary outcome
Learning of software
Time frame: 3 months
Assessment of Outcome: Each speech-language pathologist (SLP) will complete a software training then take a post-training online assessment measuring software competency.
Usability of software
Time frame: 3 months
Assessment of Outcome: SLPs will complete satisfaction surveys and attend a focus group to obtain information regarding software usability.
2 secondary outcomes
Student engagement in treatment
Time frame: 3 months
Software effectiveness
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick Shic, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPad software in people with Autism Spectrum Disorders, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning of software (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2013.