An interventional study of Video Assisted Speech Therapy (VAST) in Autism Spectrum Disorder and Apraxia of Speech, sponsored by iTherapy, LLC. Completed at 1 site in United States. Open to participants aged 4 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by iTherapy, LLC · Not applicable, Interventional, and Treatment
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.
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.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's enrollment of 6 is below the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →This is the only study on the registry with iTherapy, LLC as lead sponsor.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autism Spectrum Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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)
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)
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).
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.
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.
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.
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.
Change in Articulation Accuracy
Change in % of correct phonemes in each attempted stimulus
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.
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.
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.
Change in Type-Token Ratios
A type-token ratio measures the total number of unique words in a given segment of language.
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.
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.
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.
| Milestone | Stimuli Administered Via 2D Format on an iPad Pro | Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones |
|---|---|---|
| Started | 3 | 3 |
| Completed | 3 | 3 |
| Not completed | 0 | 0 |
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.
| Morphemes per utterance | Stimuli Administered Via 2D Format on an iPad Pro | Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones |
|---|---|---|
| Change in Mean Length of Utterance (MLU) | 0.5387 ± 0.4119 | 0.2987 ± 0.4977 |
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.
| % of correctly transcribed words | Stimuli Administered Via 2D Format on an iPad Pro | Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones |
|---|---|---|
| Change in Percentage of Correctly Transcribed Words Using Automatic Speech Recognition | 1.388 ± 1.966 | 0 ± 0 |
Change in % of correct phonemes in each attempted stimulus
| percentage of correct phonemes | Stimuli Administered Via 2D Format on an iPad Pro | Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones |
|---|---|---|
| Change in Articulation Accuracy | 19.75 ± 28.71 | 16.24 ± 2.36 |
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.
| Score on a scale | Parents of Participants, Who Received VAST Stimuli Via a 2D Format on an iPad Pro | Parents of Participants, Who Received VAST Stimuli Through VR Goggles and Bone Conduction Headphones |
|---|---|---|
| Parent Perceptions of Communication Changes, Resulting From Study Participation. | 11 ± 2.45 | 9.67 ± 4.18 |
A type-token ratio measures the total number of unique words in a given segment of language.
| number of unique words in a segment | Stimuli Administered Via 2D Format on an iPad Pro | Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones |
|---|---|---|
| Change in Type-Token Ratios | 30.158 ± 24.5 | 22.26 ± 41.18 |
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.
| Number of responses | Stimuli Administered Via 2D Format on an iPad Pro | Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones |
|---|---|---|
| Increase in Response Rate to Treatment Stimuli | 5.67 ± 3.4 | 3.33 ± 4.03 |
Collected over 7 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stimuli Administered Via 2D Format on an iPad Pro | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Stimuli Administered Via 2D Format on an iPad Pro | Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones | Total |
|---|---|---|---|
| <=18 years | 3 | 3 | 6 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Stimuli Administered Via 2D Format on an iPad Pro | Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones | Total |
|---|---|---|---|
| Mean | 5.75 ± 2.113 | 6 ± 1.938 | 5.875 ± 1.818 |
| Sex: Female, Male(Participants) | Stimuli Administered Via 2D Format on an iPad Pro | Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Stimuli Administered Via 2D Format on an iPad Pro | Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Stimuli Administered Via 2D Format on an iPad Pro | Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones | Total |
|---|---|---|---|
| United States | 3 | 3 | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — All data from individual participants will be kept private.
Ran from Dec 2019 to primary completion in Nov 2020, 11 months.
Results were first posted in May 2023, 2 years 5 months after primary completion.
Of 354 non-industry interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's 11 months is below that.
Counting every sponsor, half of 366 studies reached it within 26 months; a quarter within 13 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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