JMIR Publications

ABSTRACT

Background:

Pediatric acquired brain injury (ABI) is frequently associated with cognitive and socioemotional alterations. Targeted rehabilitation to improve everyday functioning, in particular executive functioning, is therefore needed to limit the possible deterioration of cognitive abilities and behavior over time and the associated social and psychological costs.

Objective:

Here we present the protocol for a phase II randomized controlled trial (RCT) examining the feasibility and efficacy of a web-based intervention to improve problem-solving abilities (I-TOPS intervention) versus an active-control treatment providing health and wellness content (wellness intervention).

Methods:

A double-blinded phase II RCT will be conducted to guarantee controls on data quality and findings. Forty-two adolescents will be recruited and individually randomized in a 1:1 ratio to receive the I-TOPS intervention or the wellness intervention. The two interventions will include the same number of core sessions and will be delivered remotely using a web-based platform. Participants and their caregiver will independently complete the learning modules in an everyday setting using their computer. Participants assigned to the I-TOPS intervention group will also receive direct training in problem-solving coupled with remote support from a psychologist in the problem-solving process. Feasibility and efficacy outcomes will be assessed. To test efficacy, evaluations will be performed at immediate post-training and at six-month follow-up; cognitive and behavioral outcomes of children and psychological well-being of parents will be assessed.

Results:

This study was approved by Ethics Committee of Scientific Institute, IRCCS E. Medea, Bosisio Parini, Lecco, Italy on January, 21, 2021. It started on February, 26, 2021 and ended on February, 28, 2023. A total of 42 children were enrolled and randomized into the two study groups (I-TOPS vs wellness intervention), with 34 of them that concluded the intervention and post-treatment and follow-up evaluations. Data analysis on feasibility and efficacy will be performed after protocol publication and results will be published in the form of a paper in a relevant journal in 2025.

Conclusions:

This phase II double-blinded RCT could extend knowledge on the best rehabilitation practices to adopt with survivors of pediatric ABI, by providing evidence-based data currently lacking for the Italian context. If this study yields positive results, a larger, multicenter phase III RCT could be planned and delivered to examine program cost-effectiveness in a larger sample. Clinical Trial: This study was registered with ClinicalTrials.gov with identifier NCT05169788 on December 23, 2021 (https://clinicaltrials.gov/study/NCT05169788).