Effect of Wearable Digital Intervention for Improving Socialization in Children With Autism Spectrum Disorder: A Randomized Clinical Trial

Abstract

Importance: Autism behavioral therapy is effective but expensive and difficult to access. While mobile technology-based therapy can alleviate wait-lists and scale for increasing demand, few clinical trials exist to support its use for autism spectrum disorder (ASD) care.

Objective: To evaluate the efficacy of Superpower Glass, an artificial intelligence-driven wearable behavioral intervention for improving social outcomes of children with ASD.

Design, setting, and participants: A randomized clinical trial in which participants received the Superpower Glass intervention plus standard of care applied behavioral analysis therapy and control participants received only applied behavioral analysis therapy. Assessments were completed at the Stanford University Medical School, and enrolled participants used the Superpower Glass intervention in their homes. Children aged 6 to 12 years with a formal ASD diagnosis who were currently receiving applied behavioral analysis therapy were included. Families were recruited between June 2016 and December 2017. The first participant was enrolled on November 1, 2016, and the last appointment was completed on April 11, 2018. Data analysis was conducted between April and October 2018.

Interventions: The Superpower Glass intervention, deployed via Google Glass (worn by the child) and a smartphone app, promotes facial engagement and emotion recognition by detecting facial expressions and providing reinforcing social cues. Families were asked to conduct 20-minute sessions at home 4 times per week for 6 weeks.

Main outcomes and measures: Four socialization measures were assessed using an intention-to-treat analysis with a Bonferroni test correction.

Results: Overall, 71 children (63 boys [89%]; mean [SD] age, 8.38 [2.46] years) diagnosed with ASD were enrolled (40 [56.3%] were randomized to treatment, and 31 (43.7%) were randomized to control). Children receiving the intervention showed significant improvements on the Vineland Adaptive Behaviors Scale socialization subscale compared with treatment as usual controls (mean [SD] treatment impact, 4.58 [1.62]; P = .005). Positive mean treatment effects were also found for the other 3 primary measures but not to a significance threshold of P = .0125.

Conclusions and relevance: The observed 4.58-point average gain on the Vineland Adaptive Behaviors Scale socialization subscale is comparable with gains observed with standard of care therapy. To our knowledge, this is the first randomized clinical trial to demonstrate efficacy of a wearable digital intervention to improve social behavior of children with ASD. The intervention reinforces facial engagement and emotion recognition, suggesting either or both could be a mechanism of action driving the observed improvement. This study underscores the potential of digital home therapy to augment the standard of care.

Trial registration: ClinicalTrials.gov identifier: NCT03569176.

Conflict of interest statement

Conflict of Interest Disclosures: Mr Voss reports personal fees from Cognoa, Inc. outside the submitted work; reports a pending patent (US 62/333,108); and participated in advanced contractual discussions, planning to license the patent and software enabling the Superpower Glass intervention to Cognoa, Inc. Mr Voss has been a technological consultant at Cognoa, Inc. since August 2018 and Cognoa has prepared a US Food and Drug Administration breakthrough submission based on the intervention in October 2018. As a co-owner of the intellectual property and patent with Stanford University, Mr Voss will receive licensing fees and royalties if and when the intervention is commercialized and sold as a medical product. Cognoa has not participated in any study design or analysis. The statistical analysis of this study occurred before and independent from any involvement with Cognoa and licensing discussions were started independently from the randomized clinical trial outcomes. Ms Schwartz reports no conflicts. Ms Daniels reports no conflicts. Mr Kline reports personal fees from Cognoa, Inc. outside the submitted work; reports a pending patent (US 62/333,108); and participated in advanced contractual discussions with Cognoa, Inc. with the intent to license the patent and software enabling the Superpower Glass intervention. Mr Kline has been a technological consultant at Cognoa, Inc. since September 2018 and Cognoa has prepared a US Food and Drug Administration breakthrough submission based on the intervention in October 2018. Mr Kline will receive additional milestone compensation if (a) that US Food and Drug Administration process proceeds successfully and the intervention is commercialized and sold as a medical product and (b) other company milestones not related to the Superpower Glass intervention are also met. Dr Haber reports; personal fees from Cognoa, Inc. outside the submitted work; and reports a pending patent (US 62/333,108); and participated in advanced contractual discussions, planning to license the patent and software enabling the Superpower Glass intervention to Cognoa, Inc. Dr Haber has been a technological consultant at Cognoa, Inc. since September 2018 and Cognoa has prepared a US Food and Drug Administration breakthrough submission based on the intervention in October 2018. As a co-owner of the patent with Stanford University, Dr Haber will receive licensing fees and royalties if and when the intervention is commercialized and sold as a medical product. Mr Washington reports no conflicts. Ms Tariq reports no conflicts. Dr Robinson reports no conflicts. Dr Phillips reports no conflicts. Dr Feinstein reports personal fees from Trayt.io outside the submitted work and other support from Riverside County Mental Health, Riverside University Health, and Behavioral Health Services outside the submitted work. Dr Winograd reports a pending patent (US 62/333,108). Dr Wall reports a pending patent (US 62/333,108); and participated in advanced contractual discussions, planning to license the patent and software enabling the Superpower Glass intervention to Cognoa, Inc. Cognoa is considering licensing this technology but the negotiations are not complete. Dr Wall is the founder of Cognoa, Inc. No other disclosures were reported.

Figures

Figure 1.. The Superpower Glass Intervention

The child wears smart glasses (A), which are wirelessly synced to an Android smartphone application (B), which runs the machine learning classifiers for face tracking and emotion detection, enables game choice, launches the games, and records the videos for later parent review. The outward facing camera of the glasses captures facial image data that are transmitted to the smartphone for immediate classification. A green box appears in the peripheral monitor of the glass units when a face is detected. In addition, an emoji corresponding to 1 of 8 emotions appears in the monitor when an emotion is detected. Both can appear at the same time, as demonstrated in C. The Superpower Glass intervention primarily consists of these 2 components, with the first encouraging facial awareness and the second teaching correct labeling of the emotion exhibited by the child’s social partner. The display allows colors and emoticons to be seen by the child within their peripheral field of view and does not require direct gaze. The form factor therefore rarely averts attention.

Figure 2.. Consort Flow Diagram

ABA indicates applied behavioral analysis; ASD, autism spectrum disorder; SCQ, Social Communication Questionnaire. aCompleters cohort, treatment group. bCompleters cohort, control group.