Video Assisted Speech Technology to Enhance Motor Planning for Speech

NCT04764539 | Completed Results DMC

• 1 other identifier: 1R43DC018447-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Autism Spectrum Disorder; Apraxia of Speech

Keywords

autism; apraxia; speech therapy; speech pathology; nonverbal

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

• 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.

  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.

• Change in Articulation Accuracy

  Change in % of correct phonemes in each attempted stimulus

  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)

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

  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.

• Change in Type-Token Ratios

  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.

• Increase in Response Rate to Treatment Stimuli

  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.

Study Arms (2)

Stimuli administered via 2D format on an iPad Pro

ACTIVE COMPARATOR

Participants 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).

Behavioral: Video Assisted Speech Therapy (VAST)

Stimuli administered in 3D format via VR goggles and bone conduction headphones

ACTIVE COMPARATOR

Participants 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).

Behavioral: Video Assisted Speech Therapy (VAST)

Interventions

Video Assisted Speech Therapy (VAST) BEHAVIORAL

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).

Stimuli administered in 3D format via VR goggles and bone conduction headphones; Stimuli administered via 2D format on an iPad Pro

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• No history of seizures for participating with VR goggles.

Sponsors & Collaborators

• iTherapy, LLC: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

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

Vallejo, California, 94591, United States

Location

Related Publications (14)

• 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.

  PMID: 29701730 BACKGROUND

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

  BACKGROUND

• 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).

  PMID: 18663111 BACKGROUND

• 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.

  PMID: 25901707 BACKGROUND

• 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.

  BACKGROUND

• Jang J, Matson JL, Williams LW, Tureck K, Goldin RL, Cervantes PE. RETRACTED: Rates of comorbid symptoms in children with ASD, ADHD, and comorbid ASD and ADHD. Res Dev Disabil. 2013 Aug;34(8):2369-78. doi: 10.1016/j.ridd.2013.04.021. Epub 2013 May 22.

  PMID: 23708709 BACKGROUND

• Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.

  PMID: 24413388 BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 20072702 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 8986851 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Apraxias; Autistic Disorder; Communication Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The original research plan called for testing 30 children; however, the pandemic and lockdowns required heavy modification to the research plan. We modified the design to allow subjects to participate in the study remotely. We faced further challenges in recruiting a large enough subject pool, which resulted in our recruiting 10 participants. However, despite our best efforts, the study suffered attrition of four subjects shortly before the beginning, resulting in a final N of 6.

Results Point of Contact

• Title: Lois Brady, CEO
• Organization: iTherapy, LLC

lois@itherapyllc.com

9258120037

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 21, 2021
• Study Start: December 1, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: May 9, 2023
• Results First Posted: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)