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

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e023682 ◽  
Author(s):  
K. Suzanne Scherf ◽  
Jason W Griffin ◽  
Brian Judy ◽  
Elisabeth M Whyte ◽  
Charles F Geier ◽  
...  

IntroductionAutism spectrum disorder (ASD) is characterised by impairments in social communication. Core symptoms are deficits in social looking behaviours, including limitedvisual attention to facesandsensitivity to eye gaze cues.We designed an intervention game using serious game mechanics for adolescents with ASD. It is designed to train individuals with ASD to discover that the eyes, and shifts in gaze specifically, provide information about the external world. We predict that the game will increase understanding of gaze cues and attention to faces.Methods and analysisThe 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 disseminationSAGA 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 numberNCT02968225.

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e029959 ◽  
Author(s):  
Melanie Palmer ◽  
Joanne Tarver ◽  
Juan Paris Perez ◽  
Thomas Cawthorne ◽  
Renee Romeo ◽  
...  

IntroductionThe majority of young autistic children display impairing emotional and behavioural difficulties that contribute to family stress. There is some evidence that behavioural parenting interventions are effective for reducing behavioural difficulties in autistic children, with less evidence assessing change in emotional difficulties. Previous trials have tended to use unblinded parent-report measures as primary outcomes and many do not employ an active control, limiting the conclusions that can be drawn.Methods and analysisThe Autism Spectrum Treatment and Resilience study is a pilot randomised controlled trial (RCT) testing the specific effect of a 12-week group parenting intervention (Predictive Parenting) on primary and secondary outcomes, in comparison to an attention control condition consisting of psychoeducation parent groups. Following a feasibility study to test research procedures and the interventions, the pilot RCT participants include 60 parents of autistic children aged 4–8 years who are randomised to Predictive Parenting versus the attention control. Measures are administered at baseline and post intervention to assess group differences in child and parent outcomes, costs and service use and adverse events. The primary outcome is an objective measure of child behaviours that challenge during interactions with their parent and a researcher. The trial aims to provide data on recruitment, retention, completion of measures and acceptability of the intervention and research protocol, in addition to providing a preliminary indication of potential efficacy and establishing an effect size that could be used to power a larger-scale efficacy trial. We will also provide preliminary estimates of the cost-effectiveness of the interventions.Ethics and disseminationEthical approval was granted from NHS Camden and Kings Cross Research Ethics Committee (ref: 16/LO/1769) along with NHS R&D approval from South London and Maudsley, Guy’s and St Thomas', and Croydon Health Services NHS Trusts. The findings will be disseminated through publication in peer-reviewed journals and presentations at conferences.Trial registration numberISRCTN91411078


2017 ◽  
Vol 58 (9) ◽  
pp. 1042-1052 ◽  
Author(s):  
Andrew J.O. Whitehouse ◽  
Joanna Granich ◽  
Gail Alvares ◽  
Margherita Busacca ◽  
Matthew N. Cooper ◽  
...  

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e044669
Author(s):  
Lucie Jurek ◽  
Pauline Occelli ◽  
Angelique Denis ◽  
Anouck Amestoy ◽  
Thierry Maffre ◽  
...  

IntroductionIntervention in the preschool period is currently recommended for autism spectrum disorder. Therapies delivered by parents are particularly suitable for young children. Preschool Autism Communication Trial (PACT) is a parent-mediated therapy that has shown a significant and sustained impact on autism symptom reduction. However, access to such evidence-based therapies for families is limited due to autism centres located in large urban areas. Using videoconferencing to deliver PACT training to parents may improve accessibility for families living in underserved areas.Methods and analysisThis single-blind randomised controlled trial, involving six sites in France, will investigate the efficacy of a telehealth, videoconferencing-based, parent-mediated PACT therapy on autism symptoms, over a 12-month period. It will compare PACT plus treatment as usual (TAU) against TAU only in a cohort of 238 toddlers (119 per group) aged 18–36 months at inclusion and living with their families more than 40 min away from the specialist centres for autism. Primary outcome will include change of overall autism score on the Autism Diagnostic Observation Scale (ADOS) at 12 months. Secondary outcomes will measure change in child skills, child functioning, impact on parents (stress, health, priorities) and implementation characteristics. Repeated measures analyses will be used to test the effect of PACT intervention on the overall ADOS module 1 score over the 12-month study period. Linear mixed models will be used with time, treatment allocation and the interaction between treatment and time as fixed effects and individual variation as random effect.Ethics and disseminationThis protocol (V.5, date: 25 October 2019) is approved by the French National Review Board (reference no 2018-A02516-49). The results will be disseminated via peer-reviewed journalsTrial registration numberNCT04244721.


Sign in / Sign up

Export Citation Format

Share Document