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Autism Spectrum DisorderVASTNCT04764539

Video Assisted Speech Technology to Enhance Motor Planning for Speech

A study testing Video Assisted Speech Therapy (VAST) in people with Autism Spectrum Disorder and Apraxia of Speech, run by iTherapy, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Nearly 3.5 million Americans are diagnosed with Autistic Spectrum Disorder (ASD), a communication disorder that causes skill limitations in the areas of language acquisition, sensory integration, and behavior. Read more about this study

Who is it for?
Ages 4 to 8 yearsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder, Apraxia of Speech
What is being tested?
Video Assisted Speech Therapy (VAST)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
1 Dec 2019to 30 Nov 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Nonverbal-minimally verbal children (0-5 words)
  • Diagnosis of Autism Spectrum Disorder

Who cannot join

  • No history of seizures for participating with VR goggles.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • All research was conducted via tele-research due to COVID-19

    Vallejo, California, 94591

Other trials in United States

About this study

Official title: Video Assisted Speech Technology to Enhance Functional Language Abilities in Individuals With Autism Spectrum Disorder

Nearly 3.5 million Americans are diagnosed with Autistic Spectrum Disorder (ASD), a communication disorder that causes skill limitations in the areas of language acquisition, sensory integration, and behavior. This lack of functional language ability limits conversation to its most basic parts, making daily tasks difficult for minimally to non-verbal individuals to achieve. iTherapy is developing the VAST platform, a personalized educational experience for students with ASD by creating a virtual reality-based video-modeling program to stimulate engagement and speech production practice, ultimately providing those with ASD an opportunity to enhance their quality of life by increasing their speech abilities which will enable them to build social networks and handle the events of daily life.

Read the detailed description

Autism Spectrum Disorder (ASD) is a neurodevelopmental communication disorder resulting in functional language and behavioral delays affecting over 3.5 million Americans. These delays vary with the severity of symptoms that present in ASD but often result in limited speech and increased communication challenges. Alongside linguistic acquisition, oral motor coordination is a crucial part of speech production.

Current clinical techniques have shown varying degrees of efficacy in improving functional language proficiency. Most techniques follow a drill-like procedure, where the child is made to repeat various sounds and phrases until they are retained. However, such a process requires potentially over twenty therapy sessions to show improvement which may then only be focused on one aspect of speech. This significantly limits the linguistic and social skills a student will acquire. To improve the efficacy of these therapy sessions, new technology must be developed to provide the most effective educational experience.

Video-assisted speech technology (VAST) is a method of using a video of a close-up model of the mouth and speaking simultaneously with it. Rather than present the individual with a static photograph of the initial phoneme, the entire sequence of oral movements can be presented sequentially via video-recorded segments of the orofacial area producing connected speech, combining best practices, video modeling, and literacy with auditory cues to provide unprecedented support the development of vocabulary, word combinations and communication.

In this SBIR Phase I proposal, iTherapy will develop a personalized educational experience for students with ASD by creating a virtual reality (VR) based VAST program to stimulate engagement and speech production practice. VR offers several benefits as a therapy technique: overcoming sensory difficulties, more effectively generalizing information, employing visual learning, and providing individualized treatment. As a user moves through the stages of the program, they will be immersed in a proactive environment where they will engross themselves with continuous content.

Rather than present the individual with a static photograph of the initial phoneme, the entire sequence of oral movements can be presented sequentially via VR-modelled segments of the orofacial area producing connected speech, combining best practices, video modeling, music therapy, and literacy with auditory cues to provide unprecedented support the development of vocabulary, word combinations and communication. The innovation will be a video series of a realistic VR mouth which will require the use of an app on a tablet or a smartphone, VR goggles, and bone conduction headphones.

Being tested
Video Assisted Speech Therapy (VAST)
Keywords
autism, apraxia, speech therapy, speech pathology, nonverbal
Medical subject headings
Autism Spectrum Disorder, Apraxias, Autistic Disorder, Communication Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video Assisted Speech Therapy (VAST)Behavioural

    Six children with ASD, between the ages of 4 and 8, participated in a 14-sessions-long study that utilized the VR-integrated and the tablet-based VAST application. Three subjects received a 3D VR-integrated, bone conduction VAST prototype, while the remaining group of three received a tablet with a 2D version of the software. Sessions were held twice a week with each lasting approximately 15 minutes (i.e. +/- 5 minutes).

Study groups in NCT04764539
Study groupRoleWhat they receive
Stimuli administered via 2D format on an iPad ProActive comparatorParticipants were given the Video-Assisted Speech Therapy (VAST) video-modeling stimuli in a 2D format (iPad Pro). Three children with ASD, between the ages of 4 and 8, participated in a 14-sessions-long study that utilized the tablet-based VAST application. Sessions were held twice a week with each lasting approximately 15 minutes (i.e. +/- 5 minutes).
Receives: Behavioral: Video Assisted Speech Therapy (VAST)
Stimuli administered in 3D format via VR goggles and bone conduction headphonesActive comparatorParticipants were given the Video-Assisted Speech Therapy (VAST) video-modeling stimuli in a VR format paired with a custom 3D-printed VR headset. Three children with ASD, between the ages of 4 and 8, participated in a 14-sessions-long study that utilized a 3D VR-integrated VAST prototype with bone conduction audio. Sessions were held twice a week with each lasting approximately 15 min (i.e. +/- 5 minutes).
Receives: Behavioral: Video Assisted Speech Therapy (VAST)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Mean Length of Utterance (MLU)

    Participants (aged 4 to 8 years) were given a pre- and post-test 15-minute language sample. MLU was calculated for tests and gain from pre-test to post-test was compared.

    NOTE: This measure is calculated based on a change in the number of morphemes per utterance during pre-test and post-test language samples. During a five-minute period, two licensed speech-language pathologists (SLP) observed a parent interacting and talking with their child. Parents Both SLPs transcribed the subjects' speech and calculated a mean length of utterance (MLU) for each subject. MLU was calculated by determining how many bound and free morphemes were included within every spoken utterance produced by a subject. The total number of morphemes produced within the 5-minute period were then divided by total number of utterances, which then produced the MLU for each subject. This procedure was use for determining MLU in both the pre- and post-testing procedures.

    Measured: Seven weeks--each subject participated in the study twice a week over a 7-week period for a total of 14 sessions. The first and last sessions (session #1 and session #14) were reserved for pre-test and post-test language sample collection and assessment.

  2. Change in Percentage of Correctly Transcribed Words Using Automatic Speech Recognition

    15-minute pre- and post-testing was performed using speech recognition software and transcribed by a licensed speech pathologist. Differences pre and post intervention were compared across group and within groups.

    NOTE: During our assessment, we used Google's native closed captioning function (a tool which uses machine learning to recognize and transcribe speech) and a third party app, Tactiq Pins, which allows users to keep a transcript of all speaker utterances during a call. We compared our video to the Tactiq Pin transcripts in order to measure any change in the amount of accurately transcribed spoken words between pre-test and post-test language samples. Specific transcription results for each group can be found in the data tables provided.

    Measured: Seven weeks--each subject participated in the study twice a week over a 7-week period for a total of 14 sessions. The first and last sessions (session #1 and session #14) were reserved for pre-test and post-test language sample collection and assessment.

  3. Change in Articulation Accuracy

    Change in % of correct phonemes in each attempted stimulus

    Measured: Seven weeks--each subject participated in the study twice a week over a 7-week period for a total of 14 sessions. The first and last sessions (session #1 and session #14) were reserved for pre-test and post-test language sample collection and assessment.

Secondary outcomes (3)

  1. Parent Perceptions of Communication Changes, Resulting From Study Participation.

    Parent observations -- perceptions of changes in their children's motor-speech, behavioral, and social communication skills after having participated in the study

    Scale title: Net Positive Changes Score Maximum possible value: 18 Minimum possible value: -2 Higher score is better.

    Measured: Seven weeks--each subject participated in the study twice a week over a 7-week period for a total of 14 sessions. The first and last sessions (session #1 and session #14) were reserved for pre-test and post-test language sample collection and assessment.

  2. Change in Type-Token Ratios

    A type-token ratio measures the total number of unique words in a given segment of language.

    Measured: Seven weeks--each subject participated in the study twice a week over a 7-week period for a total of 14 sessions. The first and last sessions (session #1 and session #14) were reserved for pre-test and post-test language sample collection and assessment.

  3. Increase in Response Rate to Treatment Stimuli

    The change in response rate measures any significant differences in how often children responded to pre- and post-testing stimuli after having received treatment between the iPad Pro and VR goggles groups. A response is considered a verbal or non-verbal reaction (e.g., eye contact, gestures, vocalizations) to the stimuli presented during the therapy sessions. Higher response rates indicate better engagement and responsiveness to the treatment. The change in response rate is calculated as the value at the post-test time point minus the value at the pre-test time point, with positive numbers representing increases and negative numbers representing decreases in response rate.

    Measured: Seven weeks--each subject participated in the study twice a week over a 7-week period for a total of 14 sessions. The first and last sessions (session #1 and session #14) were reserved for pre-test and post-test language sample collection and assessment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start1 Dec 2019
  3. Primary completion30 Nov 2020
  4. Study completion30 Nov 2020

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Six children with ASD, between the ages of 4 and 8, were recruited to participate in a 12-sessions-long study that utilized the Video-Assisted Speech Therapy (VAST) application. The participants were divided into two groups: one which received the VR-integrated prototype, and one that received a 2D application on a tablet. Each session was approximately 15 minutes long (+/- 5 minutes), occurring twice per week.
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04764539
Sponsor's protocol ID
1R43DC018447-01
Other IDs
1R43DC018447-01
Acronym
VAST
Status last verified
Apr 2023
First submitted
9 Feb 2021
Last updated
9 May 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All data from individual participants will be kept private.

Publications

  • Baio J, Wiggins L, Christensen DL, Maenner MJ, Daniels J, Warren Z, Kurzius-Spencer M, Zahorodny W, Robinson Rosenberg C, White T, Durkin MS, Imm P, Nikolaou L, Yeargin-Allsopp M, Lee LC, Harrington R, Lopez M, Fitzgerald RT, Hewitt A, Pettygrove S, Constantino JN, Vehorn A, Shenouda J, Hall-Lande J, Van Naarden Braun K, Dowling NF. Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2014. MMWR Surveill Summ. 2018 Apr 27;67(6):1-23. doi: 10.15585/mmwr.ss6706a1.

    PubMed 29701730

  • Autism Spectrum Disorder: Communication Problems in Children. (2018, August 30). Retrieved from https://www.nidcd.nih.gov/health/autism-spectrum-disorder-communication-problems-children

  • Maas E, Robin DA, Austermann Hula SN, Freedman SE, Wulf G, Ballard KJ, Schmidt RA. Principles of motor learning in treatment of motor speech disorders. Am J Speech Lang Pathol. 2008 Aug;17(3):277-98. doi: 10.1044/1058-0360(2008/025).

    PubMed 18663111

  • Bent S, Hendren RL. Complementary and alternative treatments for autism part 1: evidence-supported treatments. AMA J Ethics. 2015 Apr 1;17(4):369-74. doi: 10.1001/journalofethics.2015.17.4.sect1-1504. No abstract available.

    PubMed 25901707

  • Lord, C., & Paul, R. (1997). Language and communication in autism. In D. Cohen & F. Volkmar (Eds.), Handbook of autism and pervasive developmental disorders (pp. 195-225). New York, NY: Wiley.

  • Rates of comorbid symptoms in children with ASD, ADHD, and comorbid ASD and ADHD. (2013, May 22). Retrieved from https://www.sciencedirect.com/science/article/pii/S0891422213001832

  • Diagnostic and Statistical Manual of Mental Disorders (DSM-5). (n.d.). Retrieved from https://www.psychiatry.org/psychiatrists/practice/dsm

  • Symptoms and Diagnosis of ADHD | CDC. (n.d.). Retrieved from https://www.cdc.gov/ncbddd/adhd/diagnosis.html.

  • Sarah Parsons & Sue Cobb (2011) State-of-the-art of virtual reality technologies for children on the autism spectrum, European Journal of Special Needs Education, 26:3, 355-366, DOI: 10.1080/08856257.2011.593831

  • Strickland DC, McAllister D, Coles CD, Osborne S. An Evolution of Virtual Reality Training Designs for Children With Autism and Fetal Alcohol Spectrum Disorders. Top Lang Disord. 2007 Jul 1;27(3):226-241. doi: 10.1097/01.tld.0000285357.95426.72.

    PubMed 20072702

  • Evers, K., Noens, I., Steyaert, J., & Wagemans, J. (2011). Combining strengths and weaknesses in visual perception of children with an autism spectrum disorder: Perceptual matching of facial expressions. Research in Autism Spectrum Disorders,5(4), 1327-1342. doi:10.1016/j.rasd.2011.01.004

  • Strickland D, Marcus LM, Mesibov GB, Hogan K. Brief report: two case studies using virtual reality as a learning tool for autistic children. J Autism Dev Disord. 1996 Dec;26(6):651-9. doi: 10.1007/BF02172354.

    PubMed 8986851

  • Handbook of Sensory Physiology - rd.springer.com. (n.d.). Retrieved from https://rd.springer.com/content/pdf/bfm:978-3-642-88658-4/1.pdf

  • Why Speech Rate? Why are results inconclusive? (n.d.). Retrieved from https://www.asha.org/Events/convention/handouts/2007/1337_Chon_Hee_Cheong/ Brown, R. (1973) A First Language London: Allen and Unwin.

Questions about this trial

What is this clinical trial studying?

A study testing Video Assisted Speech Therapy (VAST) in people with Autism Spectrum Disorder and Apraxia of Speech, run by iTherapy, LLC 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 9 May 2023. 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?

Yes. Results are posted in the registry (first posted 9 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Mean Length of Utterance (MLU) (time frame: Seven weeks--each subject participated in the study twice a week over a 7-week period for a total of 14 sessions. The first and last sessions (session #1 and session #14) were reserved for pre-test and post-test language sample collection and assessment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04764539, which also lists 14 linked publications.

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 9 May 2023.

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