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

Not Applicable

Completed

Conditions: Autism Spectrum Disorder

Interventions: Device: Autism Glass

Registration Number: NCT03569176

Lead Sponsor: Dennis Paul Wall

Brief Summary: The purpose of this research is to study the effects of a novel artificial intelligence (AI) tool for automatic facial expression recognition that runs on Google Glass through an Android app to deliver social emotion cues to children with autism during social interactions. This novel device will use a camera, microphone, head motion tracker to analyze the behavior of the subject during interactions with other people. The system is designed to give participants non-interruptive social cues in real-time and will record social responses that can later be used to help aid behavioral therapy. It is hypothesized that the system's ability to provide continuous behavioral therapy during social interactions will enable faster gains in social skills.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 74

Inclusion Criteria

the child has been diagnosed professionally with ASD
the child is currently receiving ABA therapy at least twice per week at home.
The child's family is willing to drive to Stanford University for up to 4 study appointments.

Exclusion Criteria

The child scores less than 15 on the Social Communication Questionnaire
The child's family does not speak English

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Crossover Control for Autism Glass	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 Intervention	Autism Glass	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.

Primary Outcome Measures

Name	Time	Method
Change in Socialization Subscale Scores of the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) From Baseline to Week 6.	Baseline (week 0), Week 6	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.
Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) From Baseline to Week 6	Baseline (week 0), Week 6	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).
Change in Emotion Guessing Game (EGG) Scores From Baseline to Week 6	Baseline (week 0), Week 6	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.

Secondary Outcome Measures

Name	Time	Method
Change in ASD Symptoms as Measured by Brief Observation of Social Communication Change (BOSCC) From Baseline to Week 6	Baseline (week 0), week 6	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.
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), 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.
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), Week 6	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.
Change in NEPSY-II, Affect Recognition Subscale Scores From Baseline to Week 6	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.