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Video Assisted Speech Technology to Enhance Motor Planning for Speech (VAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04764539
Recruitment Status : Completed
First Posted : February 21, 2021
Results First Posted : May 9, 2023
Last Update Posted : May 9, 2023
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Lois Brady, iTherapy, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Autism Spectrum Disorder
Apraxia of Speech
Intervention Behavioral: Video Assisted Speech Therapy (VAST)
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stimuli Administered Via 2D Format on an iPad Pro Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Hide Arm/Group Description 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). 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).
Period Title: Overall Study
Started 3 3
Completed 3 3
Not Completed 0 0
Arm/Group Title Stimuli Administered Via 2D Format on an iPad Pro Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones Total
Hide Arm/Group Description Three children with ASD, between the ages of 4 and 8, participated in a 14-sessions-long study that utilized the tablet-based Video-Assisted Speech Therapy (VAST) application. Sessions were held twice a week with each lasting approximately 15 minutes (i.e. +/- 5 minutes). Three children with ASD, between the ages of 4 and 8, participated in a 14-sessions-long study that utilized a 3D VR-integrated Video-Assisted Speech Therapy (VAST) application, which paired bone conduction audio within a 3D-printed headset prototype. Sessions were held twice a week with each lasting approximately 15 minutes (i.e. +/- 5 minutes). Total of all reporting groups
Overall Number of Baseline Participants 3 3 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
<=18 years
3
 100.0%
3
 100.0%
6
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants
5.75  (2.113) 6  (1.938) 5.875  (1.818)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Female
3
 100.0%
2
  66.7%
5
  83.3%
Male
0
   0.0%
1
  33.3%
1
  16.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  33.3%
2
  66.7%
3
  50.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  33.3%
0
   0.0%
1
  16.7%
White
1
  33.3%
1
  33.3%
2
  33.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 6 participants
3 3 6
1.Primary Outcome
Title Change in Mean Length of Utterance (MLU)
Hide Description

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.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for each respective group.
Arm/Group Title Stimuli Administered Via 2D Format on an iPad Pro Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: Morphemes per utterance
0.5387  (0.4119) 0.2987  (0.4977)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stimuli Administered Via 2D Format on an iPad Pro, Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Comments The Mean Length of Utterance (MLU) will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.555
Comments Sample size is too small for statistical power.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-1.276 to 0.796
Parameter Dispersion
Type: Standard Deviation
Value: 0.294
Estimation Comments Difference = (VR goggles group - iPad Pro group)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Stimuli Administered Via 2D Format on an iPad Pro
Comments Comparison of pre-test and post-test outcome per group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.2128
Comments Sample size is too small for statistical power.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.5383
Confidence Interval (2-Sided) 95%
-0.471 to 1.548
Parameter Dispersion
Type: Standard Deviation
Value: 0.659
Estimation Comments Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Comments Comparison of pre-test and post-test outcome per group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.533
Comments Sample size is too small for statistical power.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.298
Confidence Interval (2-Sided) 95%
-0.915 to 1.511
Parameter Dispersion
Type: Standard Deviation
Value: 0.365
Estimation Comments Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)
2.Primary Outcome
Title Change in Percentage of Correctly Transcribed Words Using Automatic Speech Recognition
Hide Description

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.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for each respective group.
Arm/Group Title Stimuli Administered Via 2D Format on an iPad Pro Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: % of correctly transcribed words
1.388  (1.966) 0  (0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stimuli Administered Via 2D Format on an iPad Pro, Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Comments The percentage of correctly transcribed words using automatic speech recognition will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.289
Comments Sample size too small for statistical power. In addition, automated speech recognition for child speech had a very poor state-of-the-art at the time of this study.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.388
Confidence Interval (2-Sided) 95%
-1.763 to 4.539
Parameter Dispersion
Type: Standard Deviation
Value: 1.7
Estimation Comments Difference = (iPad Pro group - VR goggles group)
3.Primary Outcome
Title Change in Articulation Accuracy
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for each respective group.
Arm/Group Title Stimuli Administered Via 2D Format on an iPad Pro Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: percentage of correct phonemes
19.75  (28.71) 16.24  (2.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stimuli Administered Via 2D Format on an iPad Pro, Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Comments Articulation Accuracy does not statistically differ for the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4296
Comments Sample size is too small for statistical power.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.51
Confidence Interval (2-Sided) 95%
-49.68 to 42.66
Parameter Dispersion
Type: Standard Deviation
Value: 4.3
Estimation Comments Difference = (VR goggles group - iPad Pro group)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Stimuli Administered Via 2D Format on an iPad Pro
Comments Comparison of pre-test and post-test outcome per group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.294
Comments Sample size is too small for statistical power.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 19.75
Confidence Interval (2-Sided) 95%
-25.7 to 65.2
Parameter Dispersion
Type: Standard Deviation
Value: 24.19
Estimation Comments Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Comments Comparison of pre-test and post-test outcome per group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.419
Comments Sample size is too small for statistical power.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.25
Confidence Interval (2-Sided) 95%
-33.86 to 66.36
Parameter Dispersion
Type: Standard Deviation
Value: 19.9
Estimation Comments Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)
4.Secondary Outcome
Title Parent Perceptions of Communication Changes, Resulting From Study Participation.
Hide Description

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.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for each respective group.
Arm/Group Title 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
Hide Arm/Group Description:
Three parents parents of participants, who received stimuli administered via 2D format on an iPad Pro, answered a 5-question survey, regarding their perceptions of changes in their children's motor-speech, behavioral, and social communication skills after having participated in the study.
Three parents parents of participants -- who received stimuli administered within a 3D format that included VR goggles and bone conduction headphones -- answered a 5-question survey, regarding their perceptions of changes in their children's motor-speech, behavioral, and social communication skills after having participated in the study.
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: Score on a scale
11  (2.45) 9.67  (4.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.659
Comments Sample size to small for statistical power.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
-6.436 to 9.096
Parameter Dispersion
Type: Standard Deviation
Value: 1.63
Estimation Comments difference = (iPad group mean - VR goggles group mean)
5.Secondary Outcome
Title Change in Type-Token Ratios
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for each respective group.
Arm/Group Title Stimuli Administered Via 2D Format on an iPad Pro Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: number of unique words in a segment
30.158  (24.5) 22.26  (41.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stimuli Administered Via 2D Format on an iPad Pro, Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.789
Comments [Not Specified]
Method ANOVA
Comments Sample size too small for statistical power.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.9
Confidence Interval (2-Sided) 95%
-68.91 to 84.7
Parameter Dispersion
Type: Standard Deviation
Value: 9.67
Estimation Comments Difference = (iPad Pro group - VR Goggles group)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Stimuli Administered Via 2D Format on an iPad Pro
Comments Comparison of pre-test and post-test outcome per group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.304
Comments Sample size is too small for statistical power.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 30.16
Confidence Interval (2-Sided) 95%
-40.85 to 101.17
Parameter Dispersion
Type: Standard Deviation
Value: 36.94
Estimation Comments Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Comments Comparison of pre-test and post-test outcome per group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.403
Comments Sample size is too small for statistical power.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 22.26
Confidence Interval (2-Sided) 95%
-43.91 to 88.43
Parameter Dispersion
Type: Standard Deviation
Value: 27.26
Estimation Comments Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)
6.Secondary Outcome
Title Increase in Response Rate to Treatment Stimuli
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants for each respective group.
Arm/Group Title Stimuli Administered Via 2D Format on an iPad Pro Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: Number of responses
5.67  (3.4) 3.33  (4.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stimuli Administered Via 2D Format on an iPad Pro, Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Comments The response to treatment stimuli will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.485
Comments Sample size is too small for statistical power.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.34
Confidence Interval (2-Sided) 95%
-10.79 to 6.11
Parameter Dispersion
Type: Standard Deviation
Value: 2.87
Estimation Comments Difference = (VR goggles group - iPad Pro group)
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Stimuli Administered Via 2D Format on an iPad Pro
Comments Comparison of pre-test and post-test outcome per group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.065
Comments Sample size is too small for statistical power.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.66
Confidence Interval (2-Sided) 95%
-0.569 to 11.9
Parameter Dispersion
Type: Standard Deviation
Value: 6.94
Estimation Comments Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Comments Comparison of pre-test and post-test outcome per group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.549
Comments Sample size is too small for statistical power.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.34
Confidence Interval (2-Sided) 95%
-10.85 to 17.53
Parameter Dispersion
Type: Standard Deviation
Value: 4.09
Estimation Comments Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)
Time Frame 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.
Adverse Event Reporting Description Our study used a teletherapy platform, which posed no serious risk of physical harm, little to no exposure to psychological harm, social-economic risk, loss of confidentiality, or legal risk.
 
Arm/Group Title Stimuli Administered Via 2D Format on an iPad Pro Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Hide Arm/Group Description 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). 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).
All-Cause Mortality
Stimuli Administered Via 2D Format on an iPad Pro Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Hide Serious Adverse Events
Stimuli Administered Via 2D Format on an iPad Pro Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stimuli Administered Via 2D Format on an iPad Pro Stimuli Administered in 3D Format Via VR Goggles and Bone Conduction Headphones
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lois Brady, CEO
Organization: iTherapy, LLC
Phone: 9258120037
EMail: lois@itherapyllc.com
Publications:
Autism Spectrum Disorder: Communication Problems in Children. (2018, August 30). Retrieved from https://www.nidcd.nih.gov/health/autism-spectrum-disorder-communication-problems-children
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.
Symptoms and Diagnosis of ADHD | CDC. (n.d.). Retrieved from https://www.cdc.gov/ncbddd/adhd/diagnosis.html.
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Layout table for additonal information
Responsible Party: Lois Brady, iTherapy, LLC
ClinicalTrials.gov Identifier: NCT04764539    
Other Study ID Numbers: 1R43DC018447-01 ( U.S. NIH Grant/Contract )
1R43DC018447-01 ( U.S. NIH Grant/Contract )
First Submitted: February 9, 2021
First Posted: February 21, 2021
Results First Submitted: June 10, 2022
Results First Posted: May 9, 2023
Last Update Posted: May 9, 2023