Trial Outcomes & Findings for Examining the Efficacy of a Mobile Therapy for Children With Autism Spectrum Disorder (NCT NCT03569176)

Last Updated: 2024-12-20

Results Overview

Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) Socialization subscale will be conducted at the university by a trained research team member. Scores from the socialization domain of the VABS-II reflects one's functioning in social situations. The socialization subscale is 32 items, where raw scores are converted to IQ-type standard scores (mean: 100 sd: 15) for each domain and for the composite adaptive behavior score.The socialization subscale is 32 items, where raw scores are converted to IQ-type standard scores--v-scale scores (M=15, SD=3) where scores range from 1 to 24, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning.

Recruitment status

COMPLETED

Study phase

Target enrollment

74 participants

Primary outcome timeframe

Baseline (week 0), Week 6

Results posted on

2024-12-20

Participant Flow

N=3 participants were excluded due to a randomization error.

Participant milestones

Participant milestones
Measure	Autism Glass Intervention Participants in the experimental group will receive the autism glass for 6 weeks once they are assigned to the experimental condition. Participants will be asked to use the glasses at least 3 times a week for 20 minutes sessions in addition to continuing Applied Behavior Analysis (ABA) therapy. Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.	Crossover Control for Autism Glass Participants randomized to the control arm, will continue treatment as usual (receiving ABA twice a week) while the intervention participants will receive the Autism Glass intervention (while continuing to receive ABA therapy). After 6 weeks, control participants will receive the Autism Glass intervention after which, they will be asked to come in for a second round of follow-up testing following 6 weeks of use (at week 18). Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.
Baseline (week0) to Post-Test 1 (week6) STARTED	40	31
Baseline (week0) to Post-Test 1 (week6) COMPLETED	27	25
Baseline (week0) to Post-Test 1 (week6) NOT COMPLETED	13	6
Post-Test1(week6) to Post-Test2(week12) STARTED	27	25
Post-Test1(week6) to Post-Test2(week12) COMPLETED	24	12
Post-Test1(week6) to Post-Test2(week12) NOT COMPLETED	3	13
Post-Test1(week12) to Post-Test2(week18) STARTED	0	12
Post-Test1(week12) to Post-Test2(week18) COMPLETED	0	12
Post-Test1(week12) to Post-Test2(week18) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Examining the Efficacy of a Mobile Therapy for Children With Autism Spectrum Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autism Glass Intervention n=40 Participants Participants in the experimental group will receive the autism glass for 6 weeks once they are assigned to the experimental condition. Participants will be asked to use the glasses at least 3 times a week for 20 minutes sessions in addition to continuing Applied Behavior Analysis (ABA) therapy. Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.	Crossover Control for Autism Glass n=31 Participants Participants randomized to the control arm, will continue treatment as usual (receiving ABA twice a week) while the intervention participants will receive the Autism Glass intervention (while continuing to receive ABA therapy). After 6 weeks, control participants will receive the Autism Glass intervention after which, they will be asked to come in for a second round of follow-up testing following 6 weeks of use (at week 18). Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.	Total n=71 Participants Total of all reporting groups
Age, Continuous	8.64 years STANDARD_DEVIATION 2.52 • n=5 Participants	7.94 years STANDARD_DEVIATION 1.69 • n=7 Participants	8.38 years STANDARD_DEVIATION 2.46 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	26 Participants n=7 Participants	63 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Caucasian or Euro-American	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · East Asian or Asian American	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · South Asian or Indian American	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Middle Eastern or Arab American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Native American or Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Hispanic/Latino/Spanish Origin	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · More than one race selected	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Unknown/Not Listed	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Stanford-Binet Intelligence Scales, Abbreviated Battery, Fifth Edition (ABIQ)	75.7 points STANDARD_DEVIATION 20.71 • n=5 Participants	80.42 points STANDARD_DEVIATION 22.61 • n=7 Participants	77.76 points STANDARD_DEVIATION 21.53 • n=5 Participants
Mobilized Machine Learning Autism Risk Assessment (MARA) score of autism severity	-5.57 units on a scale STANDARD_DEVIATION 4.08 • n=5 Participants	-4.33 units on a scale STANDARD_DEVIATION 4.37 • n=7 Participants	-5.02 units on a scale STANDARD_DEVIATION 4.22 • n=5 Participants
Social Communication Questionnaire (SCQ) score	23.43 points STANDARD_DEVIATION 5.13 • n=5 Participants	25.06 points STANDARD_DEVIATION 4.81 • n=7 Participants	24.14 points STANDARD_DEVIATION 5.03 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (week 0), Week 6

Population: Averages at baseline are averages from the original N=40 intervention cohort and N=31 crossover control cohort.

Outcome measures

Outcome measures
Measure	Autism Glass Intervention n=40 Participants Participants in the experimental group will receive the autism glass for 6 weeks once they are assigned to the experimental condition. Participants will be asked to use the glasses at least 3 times a week for 20 minutes sessions in addition to continuing Applied Behavior Analysis (ABA) therapy. Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.	Crossover Control for Autism Glass n=31 Participants Participants randomized to the control arm, will continue treatment as usual (receiving ABA twice a week) while the intervention participants will receive the Autism Glass intervention (while continuing to receive ABA therapy). After 6 weeks, control participants will receive the Autism Glass intervention after which, they will be asked to come in for a second round of follow-up testing following 6 weeks of use (at week 18). Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.
Change in Socialization Subscale Scores of the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) From Baseline to Week 6. Baseline (week 0)	68.75 score on a scale Standard Deviation 16.63	70.40 score on a scale Standard Deviation 13.26
Change in Socialization Subscale Scores of the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) From Baseline to Week 6. Post-Test 1 (week 6)	71.72 score on a scale Standard Deviation 15.24	68.6 score on a scale Standard Deviation 10.80

PRIMARY outcome

Timeframe: Baseline (week 0), Week 6

Population: Averages at baseline are averages from the original N=40 intervention cohort and N=31 crossover control cohort.

The SRS-2 is a 65-item measure where parents rate their child selecting responses on a Likert Scale. This measure will be used to measure and identify social impairment associated with Autism Spectrum Disorder (ASD) and to quantify its severity. Social Responsiveness Scale (SRS) raw scores measure social abilities with lower scores indicating better social skills. (Raw Score Range: 0 - 195 and T-Score Range: 37- above 90).

Outcome measures

Outcome measures
Measure	Autism Glass Intervention n=40 Participants Participants in the experimental group will receive the autism glass for 6 weeks once they are assigned to the experimental condition. Participants will be asked to use the glasses at least 3 times a week for 20 minutes sessions in addition to continuing Applied Behavior Analysis (ABA) therapy. Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.	Crossover Control for Autism Glass n=31 Participants Participants randomized to the control arm, will continue treatment as usual (receiving ABA twice a week) while the intervention participants will receive the Autism Glass intervention (while continuing to receive ABA therapy). After 6 weeks, control participants will receive the Autism Glass intervention after which, they will be asked to come in for a second round of follow-up testing following 6 weeks of use (at week 18). Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.
Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) From Baseline to Week 6 Baseline (week 0)	80.68 score on a scale Standard Deviation 8.41	80.76 score on a scale Standard Deviation 10.98
Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) From Baseline to Week 6 Post-Test 1 (week 6)	78.4 score on a scale Standard Deviation 8.65	81.79 score on a scale Standard Deviation 8.38

PRIMARY outcome

Timeframe: Baseline (week 0), Week 6

Population: Averages at baseline are averages from the original N=40 intervention cohort and N=31 crossover control cohort.

The Emotion Guessing Game is a novel test created for purposes of this study to evaluate the child's ability to correctly label emotions expressed by an examiner in real time. EGG is a pre-set list of 8 emotions, listed 5 times each (Happy, Sad, Angry, Afraid, Surprised, Calm, Disgust, and "Meh"/contempt). During the quick 40-question evaluation, the research coordinator first lists the various emotion choices to the child before beginning the evaluation. Then, the examiner acts out each emotion listed, in order, and waits for a guess from the child, who labels the emotion. The EGG is scored by summing the number of correct responses from the child, higher scores indicated better emotion recognition, where scores can range from 0 to 40.

Outcome measures

Outcome measures
Measure	Autism Glass Intervention n=40 Participants Participants in the experimental group will receive the autism glass for 6 weeks once they are assigned to the experimental condition. Participants will be asked to use the glasses at least 3 times a week for 20 minutes sessions in addition to continuing Applied Behavior Analysis (ABA) therapy. Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.	Crossover Control for Autism Glass n=31 Participants Participants randomized to the control arm, will continue treatment as usual (receiving ABA twice a week) while the intervention participants will receive the Autism Glass intervention (while continuing to receive ABA therapy). After 6 weeks, control participants will receive the Autism Glass intervention after which, they will be asked to come in for a second round of follow-up testing following 6 weeks of use (at week 18). Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.
Change in Emotion Guessing Game (EGG) Scores From Baseline to Week 6 Baseline (week 0)	22.80 score on a scale Standard Deviation 11.52	24.74 score on a scale Standard Deviation 11.66
Change in Emotion Guessing Game (EGG) Scores From Baseline to Week 6 Post-Test 1 (week 6)	30.03 score on a scale Standard Deviation 9.44	26.88 score on a scale Standard Deviation 11.44

SECONDARY outcome

Timeframe: Baseline (week 0), week 6

Population: While the framework for administration of BOSCC has been published, the scoring algorithm and validation of use in independent replicate samples has not yet been published. Therefore, we were unable to use the BOSCC as initially planned.

The Brief Observation of Social Communication Change (BOSCC) is designed to measure change in core symptoms of children with autism. It aims to capture change in social communication, interaction, and eye contact. The BOSCC is a play based assessment that consists of two boxes filled with specific toys and takes about 12 minutes to complete.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week 0), week 6

The VABS-II is a robust and comprehensive measure of personal and social skills needed in everyday living. The VABS-II covers a child's conceptual, social, and practical skills and can assess children from birth to 90 years. The parent can complete the entire questionnaire in about 20-30 minutes. The raw score in each domain and total raw score are converted to an age-equivalent score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The range for each subscale is from 20 to 140. The subscales are summed to compute a total score, ranging from 80 to 560. The higher the scores are, the better adaptive functioning the children achieve.

Outcome measures

Outcome measures
Measure	Autism Glass Intervention n=40 Participants Participants in the experimental group will receive the autism glass for 6 weeks once they are assigned to the experimental condition. Participants will be asked to use the glasses at least 3 times a week for 20 minutes sessions in addition to continuing Applied Behavior Analysis (ABA) therapy. Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.	Crossover Control for Autism Glass n=31 Participants Participants randomized to the control arm, will continue treatment as usual (receiving ABA twice a week) while the intervention participants will receive the Autism Glass intervention (while continuing to receive ABA therapy). After 6 weeks, control participants will receive the Autism Glass intervention after which, they will be asked to come in for a second round of follow-up testing following 6 weeks of use (at week 18). Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.
Change in Adaptive Social and Personal Skills as Measured by Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) Full Scale From Baseline to Week 6. Baseline (week 0)	71.45 score on a scale Standard Deviation 12.66	74.63 score on a scale Standard Deviation 10.48
Change in Adaptive Social and Personal Skills as Measured by Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) Full Scale From Baseline to Week 6. Post-Test 1 (week 6)	72.29 score on a scale Standard Deviation 15.46	74.48 score on a scale Standard Deviation 9.79

SECONDARY outcome

Timeframe: Baseline (week 0), Week 6

Population: CBCL Total Score Averages at baseline are averages from the original N=40 intervention cohort and N=31 crossover control cohort.

The CBCL is a caregiver-directed report that identifies emotional, behavioral, and social problems in children. The patient is rated on 113 items scored on a 3-point Likert-type scale. CBCL total score consists of eight empirically-based syndrome subscales. The total competence score is reported, range: 0-100, where higher scores suggests the more severe symptoms.

Outcome measures

Outcome measures
Measure	Autism Glass Intervention n=40 Participants Participants in the experimental group will receive the autism glass for 6 weeks once they are assigned to the experimental condition. Participants will be asked to use the glasses at least 3 times a week for 20 minutes sessions in addition to continuing Applied Behavior Analysis (ABA) therapy. Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.	Crossover Control for Autism Glass n=31 Participants Participants randomized to the control arm, will continue treatment as usual (receiving ABA twice a week) while the intervention participants will receive the Autism Glass intervention (while continuing to receive ABA therapy). After 6 weeks, control participants will receive the Autism Glass intervention after which, they will be asked to come in for a second round of follow-up testing following 6 weeks of use (at week 18). Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.
Change in Child's Emotional, Behavioral, and Social Problems From Baseline (Week 0) to Week 6 as Measured by Child Behavior Checklist (CBCL) Total Score. Baseline (week 0)	65.95 score on a scale Standard Deviation 7.16	69.04 score on a scale Standard Deviation 7.39
Change in Child's Emotional, Behavioral, and Social Problems From Baseline (Week 0) to Week 6 as Measured by Child Behavior Checklist (CBCL) Total Score. Post-Test 1 (week 6)	63.77 score on a scale Standard Deviation 6.84	65.55 score on a scale Standard Deviation 8.94

SECONDARY outcome

Timeframe: Baseline (week 0), Week 6 Baseline (week 0), Week 6 Baseline (week 0), Week 6 Baseline (week 0), week 6

The NEPSY-II Affect Recognition subdomain assesses a child's social perception of facial affect recognition. It is designed to assess a child's ability to recognize 6 emotions (happy, sad, angry, fear, disgust, and neutral) from colored photographs of children's faces in four different tasks. Scores range from 1 (well below expected level) to 19 (well above expected level), and have a mean of 10 \[standard deviation= 3\] that is based on a U.S. normative sample.

Outcome measures

Outcome measures
Measure	Autism Glass Intervention n=40 Participants Participants in the experimental group will receive the autism glass for 6 weeks once they are assigned to the experimental condition. Participants will be asked to use the glasses at least 3 times a week for 20 minutes sessions in addition to continuing Applied Behavior Analysis (ABA) therapy. Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.	Crossover Control for Autism Glass n=31 Participants Participants randomized to the control arm, will continue treatment as usual (receiving ABA twice a week) while the intervention participants will receive the Autism Glass intervention (while continuing to receive ABA therapy). After 6 weeks, control participants will receive the Autism Glass intervention after which, they will be asked to come in for a second round of follow-up testing following 6 weeks of use (at week 18). Autism Glass: The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.
Change in NEPSY-II, Affect Recognition Subscale Scores From Baseline to Week 6	.099 units on a scale Standard Deviation .570	-.068 units on a scale Standard Deviation .439

Adverse Events

Autism Glass Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Crossover Control for Autism Glass

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dennis P. Wall

Stanford University

Phone: 650-497-9214

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place