Outcomes of Providing Children Aged 7-12 Years With Access to Evidence-Based Anxiety Treatment Via a Standalone Digital Intervention Using Immersive Gaming Technology: Real-World Evaluation.

Background: Anxiety disorders are among the most common mental health conditions in childhood, but most children with anxiety disorders do not access evidence-based interventions. The delivery of therapeutic interventions via digital technologies has been proposed to significantly increase timely access to evidence-based treatment. Lumi Nova (BfB Labs Limited) is a digital therapeutic intervention designed to deliver evidence-based anxiety treatment for those aged 7-12 years through a mobile app incorporating immersive gaming technology.

Objective: We aimed to evaluate the real-world impact of providing access to Lumi Nova through UK National Health Service-funded mental health services.

Methods: We analyzed precollected anonymized data routinely captured through the implementation of Lumi Nova from children aged 7-12 years, who lived in the United Kingdom and had the opportunity to use the intervention for at least 1 week over an 18-month period. Engagement indices included whether the game key was activated, number of unique sessions, time spent engaging, and number of "challenges" completed. Clinical outcomes were assessed using the Goal-Based Outcomes measure and Child Outcome Rating Scale. Demographic data were analyzed to assess the health equality implications of Lumi Nova.

Results: Of 1029 eligible families invited to use Lumi Nova, 644 (62.5%) activated their game key, of whom 374 (58.1%) completed at least one in-game graded exposure challenge. The median number of unique sessions was 6 (IQR 3-12) and the median time spent engaging with the intervention was 42 (IQR 15-79) minutes. For the subset of young people with paired outcomes, there were statistically significant small to medium improvements in goal-based outcome scores (n=224; t223=5.78, P<.001; d=0.37, 95% CI 0.25-0.52) and Child Outcome Rating Scale scores (n=123; t122=5.10, P<.001; d=0.46, 95% CI 0.27-0.65) between the first and last data points. Two in 5 young people's scores reflected a change that would be considered reliable. Analysis of demographic characteristics tentatively suggested that children from ethnic minority backgrounds and those living in the most deprived neighbourhoods may be less likely to access Lumi Nova, but children from socioeconomically deprived areas were more likely to successfully complete a challenge once they accessed the intervention (P=.02). However, the level of missing data and small number of children in some demographic groups limited meaningful statistical comparisons.

Conclusions: This study provides initial evidence that Lumi Nova may be associated with improved outcomes for those aged 7-12 years seeking anxiety treatment in real-world settings. However, the lack of a control comparator group and information about concurrent treatments accessed by the young people, in addition to substantial attrition, limited the analysis that could be conducted and confidence in the conclusions drawn.