Proof-of-Concept Study Results of an Interactive Digital Treatment for Pediatric ADHD and Follow-Up Registration Study Design
This poster was presented at the 30th annual Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.
OBJECTIVES: Pharmacological interventions are well established in the treatment of pediatric ADHD but they can be associated with unwanted side effects. An exploratory study was conducted to assess the impact of a novel, interactive and adaptive digital cognitive intervention in pediatric ADHD.
METHODS: ADHD ratings and neuropsychological assessments of cognitive function were assessed at baseline and following completion of a 28-day at-home digital treatment (5 weekly 30-min sessions), using proprietary software on a digital tablet.
RESULTS: Forty ADHD and 40 neuro-typical children (mean age = 10.3 years) were recruited from 3 U.S. sites. No treatment related adverse events were reported and 84% of all prescribed sessions were completed. The ADHD group showed a significant improvement in the Attention Performance Index TOVA (API) score (P=0.03), as well as in 8/12 variables of the CANTAB Spatial Working Memory (SWM) test (P<0.05). A post-hoc analysis of a sub-group of ADHD participants with greater cognitive and symptom severity at baseline showed a larger effect of the intervention on the API (P<0.01, Coen's d=0.71), a significant improvement in 8/12 CANTAB SWM variables (P<0.05), and in the Parent-BRIEF working memory and Inhibit subscales (P<0.03).
REGISTRATION STUDY DESIGN: A randomized, controlled, parallel-group, intervention pivotal study to assess the safety and efficacy of an at-home 28-day treatment with this multitasking digital intervention versus a non-multitasking digital intervention has been initiated.
CONCLUSIONS: The positive results of the Proof-of Concept study provided support for this novel interactive digital intervention. Completion of the ongoing registration trial is expected in Q4 2017.