Implementation of the Italian Version of the web-based Teen Online Problem-Solving (TOPS) Program coupled with remote psychological support via video meetings for adolescents with acquired brain injury: A Protocol for a Randomized Controlled Trial

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Corti, Claudia; Papini, Marta; Strazzer, Sandra; Borgatti, Renato; Romaniello, Romina; Poggi, Geraldina; Storm, Fabio A.; Urgesi, Cosimo; Jansari, Ashok S.; Wade, Shari L. and Bardoni, Alessandra. 2025. Implementation of the Italian Version of the web-based Teen Online Problem-Solving (TOPS) Program coupled with remote psychological support via video meetings for adolescents with acquired brain injury: A Protocol for a Randomized Controlled Trial. Journal of Medical Internet Research - Research Protocols, ISSN 1438-8871 [Article] (In Press)

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Abstract or Description

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

Objectives
Here we present the protocol for a phase II randomized controlled trial (RCT) aimed at examining the feasibility and efficacy of a web-based intervention to improve problem-solving abilities (I-TOPS intervention) versus an active-control web-based intervention 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 from a rehabilitation institute and individually randomized in a 1:1 ratio to receive the online I-TOPS intervention or the online 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 caregiver(s) will independently complete the learning modules in an everyday setting using their computer. The I-TOPS core sessions will target the EF domain (e.g., planning, emotion regulation, 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 adolescent’s and parent’s functioning will be assessed. Cognitive abilities in the EF domain and behavioral and psychological functioning (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 post-training and at a 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 randomized into the 2 study groups (I-TOPS vs wellness intervention), and 34 adolescents (19 I-TOPS and 15 wellness) completed 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.

Item Type:

Article

Additional Information:

Trial registration: This study was registered with ClinicalTrials.gov (NCT05169788) https://clinicaltrials.gov/search?term=NCT05169788

Funding Information: This study was supported by Italian Ministry of Health (Ricerca Corrente 2022-2024 to S.S.) and "5 per mille" funds for biomedical research.

Keywords:

telerehabilitation; acquired-brain-injury; executive-functioning; pediatric; problem-solving

Departments, Centres and Research Units:

Psychology

Dates: