Improving sensitivity to eye gaze cues in autism using serious game technology: study protocol for a phase I randomised controlled trial.

introductionAutism spectrum disorder (ASD) is characterised by impairments in social communication. Core symptoms are deficits in social looking behaviours, including limited METHODS AND ANALYSIS: The Social Games for Adolescents with Autism (SAGA) trial is a preliminary, randomised controlled trial comparing the intervention game with a waitlist control condition. 34 adolescents (10-18 years) with ASD with a Full-Scale IQ between 70 and 130 and a minimum second grade reading level, and their parents, will be randomly assigned (equally to intervention or the control condition) following baseline assessments. Intervention participants will be instructed to play the computer game at home on a computer for ~30 min, three times a week. All families are tested in the lab at baseline and approximately 2 months following randomisation in all measures. Primary outcomes are assessed with eye tracking to measure sensitivity to eye gaze cues and social visual attention to faces; secondary outcomes are assessed with questionnaires to measure social skills and autism-like behaviours. The analyses will focus on evaluating the feasibility, safety and preliminary effectiveness of the intervention. ETHICS AND DISSEMINATION: SAGA is approved by the Institutional Review Board at Pennsylvania State University (00005097). Findings will be disseminated via scientific conferences and peer-reviewed journals and to participants via newsletter. The intervention game will be available to families in the control condition after the full data are collected and if analyses indicate that it is effective. TRIAL REGISTRATION NUMBER: NCT02968225.