Randomized clinical trial on the effects of early cognitive interventions for children with acquired brain injury.

Pediatric acquired brain injuries (ABIs) may cause significant cognitive deficits. Early rehabilitation is recommended, but there is no solid evidence on the best intervention formats. This randomized clinical trial investigated the efficacy of two multidomain cognitive interventions for children aged 5:0-17:11. A personalized intervention was compared with an intervention providing a fixed-dose cognitive stimulation. 40 children were randomized into the 2 study arms and received 12-week rehabilitation (3 45-minute daily sessions for 5 days per week). 34 children completed the intervention and were assessed at baseline (T0) and post-intervention (T1). Visual sustained attention and other cognitive measures of attention, memory, visual-spatial/visual-constructional abilities and executive functions were primary and secondary outcomes, respectively. Primary and 14 of the 16 secondary outcomes showed an improvement at T1 with a medium-to-very-large effect, but training effects could not be disentangled from spontaneous recovery. No differences were found between interventions, likely because of the prolonged multidomain stimulation provided by both of them, which might have been helpful in improving the widespread cognitive deficits of children in both groups. Therefore, while for the chronic phase the guidelines recommend a personalized approach, in the early phase of recovery a standardized intervention may also be effective.