A Randomized Controlled Trial of A Gamified Digital Mental Health Intervention for Child Anxiety.

Childhood anxiety is common and represents a public health concern. Digital mental health interventions (DMHIs) show benefit for improving mental health outcomes and represent one option to increase access to cognitive behavioral therapy skills-but often have low engagement. We conducted a randomized controlled trial (RCT) that examined a gamified DMHI for the treatment of children with mild-to-moderate anxiety. 118 child-parent dyads were randomly assigned to receive a gamified DMHI, digital bibliotherapy, or a waitlist condition. After six weeks, participants completed a post-treatment assessment to characterize change in symptom severity. Participants in intervention groups completed a follow-up assessment six weeks later to characterize continued symptom improvement. Random-intercept linear models identified that the DMHI produced reductions in child anxiety severity at Week 6 relative to the waitlist (effect size = 0.36-0.60). There was improvement in parental anxiety sensitivity for all digital interventions at Week 6 compared to the waitlist (effect size = 0.48-0.50), but effects were non-significant after correcting for multiple comparisons. An exploratory mediation model found that change in parent anxiety sensitivity had an indirect effect on the reduction in child anxiety severity for digital interventions. The gamified DMHI demonstrated efficacy for reducing child anxiety severity in comparison to a waitlist. The exploratory indirect effect analysis generates hypotheses about the role of anxiety sensitivity as a possible mechanism of therapeutic improvement. Findings highlight the potential for the DMHI to serve as an accessible and scalable intervention to reduce child anxiety and inform the study design for a subsequent RCT.