Examining the Implementation of the Italian Version of the Teen Online Problem-Solving Program Coupled With Remote Psychological Support: Protocol for a Randomized Controlled Trial
Authors: Corti Claudia , Papini Marta , Strazzer Sandra , Borgatti Renato , Romaniello Romina , Poggi Geraldina , Storm Fabio Alexander , Urgesi Cosimo , Jansari Ashok , Wade Shari L , Bardoni Alessandra 
Published: November 2024

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

Objective
In this paper, we present the protocol for a phase-2 randomized controlled trial (RCT) aimed at examining the feasibility and efficacy of a web-based intervention (ie, the Italian version of the Teen Online Problem-Solving [I-TOPS] intervention) to improve problem-solving abilities versus an active-control, web-based intervention (ie, wellness intervention) providing health and wellness content.

Methods
A double-blinded, phase-2 RCT will be conducted to guarantee controls on data quality and findings. In total, 42 adolescents will be recruited from a rehabilitation institute and individually randomly assigned in a 1:1 ratio to receive the I-TOPS intervention or the web-based wellness intervention. Both interventions will include 10 core sessions and will be delivered remotely using a web-based platform. Participants allocated to both interventions and their caregivers will independently complete the learning modules in an everyday setting using their computer. The I-TOPS intervention’s core sessions will target the EF domain (eg, planning, emotion regulation, and social skills), while all the contents of the wellness intervention will be aimed at providing psychoeducation on ABI sequelae and supporting health and wellness. Participants assigned to the I-TOPS intervention will also receive bimonthly direct training in problem-solving coupled with remote support from a psychologist. Feasibility data and efficacy outcomes on both adolescents’ and parents’ functioning will be assessed. Cognitive abilities in the EF domain and behavioral and psychological functioning (ie, internalizing and externalizing symptoms) of the adolescents will be evaluated via performance-based measures, administered remotely using the Google Meet platform, and paper-and-pencil questionnaires; parents’ well-being will be assessed through paper-and-pencil questionnaires. Efficacy will be evaluated immediately after training and at 6-month follow-up.

Results
This study started on February 26, 2021, and ended on February 28, 2023. A total of 42 adolescents were enrolled and randomly assigned to the 2 study groups, 34 (81%) completed the intervention and posttreatment evaluation (I-TOPS: n=19 and wellness intervention: n=15) and 31 performed follow-up evaluation (I-TOPS: n=18 and wellness intervention: n=13). Data analysis on feasibility and efficacy will be performed after protocol publication, and the results will be published in the form of a paper in a relevant journal in 2025.

Conclusions
This double-blinded, phase-2 RCT could extend knowledge on the best rehabilitation practices to adopt with the 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-3 RCT could be planned and delivered to examine program cost-effectiveness in a larger sample.

Trial Registration
ClinicalTrials.gov NCT05169788; https://clinicaltrials.gov/study/NCT05169788

International Registered Report Identifier (IRRID)
DERR1-10.2196/64178