Rehabilitation Through the Italian Version of the Teen Online Problem-Solving (TOPS) Program
NCT ID: NCT05169788
Last Updated: 2025-05-02
Study Results
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Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2021-02-26
2023-02-28
Brief Summary
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In order to control for placebo effects, participants are randomized into two intervention conditions. Group 1 performs the regular version of the TOPS, while Group 2 performs a modified version containing no activities on executive functions, behavioral strategies and social skills.
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Detailed Description
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Assessment of executive functions and behavioral problems is conducted before and after the training (immediate post training assessment and follow-up assessment 6 months after the end of the training), in order to investigate the presence of significant changes after the intervention. Both questionnaires and performance-based measures are used.
Participants are randomized into two groups: Group 1 performs the regular version of the TOPS, while Group 2 performs a modified version containing no activities on executive functions, behavioral strategies and social skills.
Based on the average effect of TOPS program reported by a meta-analysis available in the literature (Corti et al., 2019; Hedge's g = 0.39) we estimated a small-to-moderate effect size of f =0.2 (f was calculated based on Hedge's g value). Power analysis was conducted by using GPower3 software. Assuming a correlation of 0.50 between repeated measures and setting the alfa level at P \< 0.05, a sample size of 21 subjects per group is required to obtain 80% of power with our 2 groups x 3 time points design.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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regular TOPS group
Patients are required to perform the regular TOPS program, composed of 10 core sessions and other eventual supplementary sessions. In addition, biweekly Google Meet sessions with a cognitive-behavioral psychotherapist are scheduled, with the aim to monitor patients' activities on problem-solving related to the TOPS program contents and the problem solving process in real life. The program has a specific focus on problem-solving, executive functions, behavioral strategies and social skills.
Teen On-line Problem Solving
The TOPS program is a web-based platform delivered on computers and tablets, which is composed of different self-guided, online sessions on different contents: executive functions, social skills, behavioral strategies, injury-related issues and health and wellness. The TOPS program has been designed to be performed by patients and their families at home. Biweekly Google Meet videoconferences between a coach with expertise in cognitive-behavioral psychotherapy and patients are scheduled along the entire duration of the program.
modified TOPS group
Patients are required to perform the modified TOPS program, composed of 10 sessions focused only on health and wellness contents. Thus, this program does not include contents on problem-solving, executive functions, behavioral strategies and social skills, representing a low cognitively simulating activity. Biweekly Google Meet sessions with a cognitive-behavioral psychotherapist are scheduled, with the aim of monitoring training adherence and discuss the program's contents.
Teen On-line Problem Solving
The TOPS program is a web-based platform delivered on computers and tablets, which is composed of different self-guided, online sessions on different contents: executive functions, social skills, behavioral strategies, injury-related issues and health and wellness. The TOPS program has been designed to be performed by patients and their families at home. Biweekly Google Meet videoconferences between a coach with expertise in cognitive-behavioral psychotherapy and patients are scheduled along the entire duration of the program.
Interventions
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Teen On-line Problem Solving
The TOPS program is a web-based platform delivered on computers and tablets, which is composed of different self-guided, online sessions on different contents: executive functions, social skills, behavioral strategies, injury-related issues and health and wellness. The TOPS program has been designed to be performed by patients and their families at home. Biweekly Google Meet videoconferences between a coach with expertise in cognitive-behavioral psychotherapy and patients are scheduled along the entire duration of the program.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* familiarity for psychiatric hospitalization
11 Years
19 Years
ALL
No
Sponsors
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IRCCS Eugenio Medea
OTHER
Responsible Party
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Locations
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Scientific Institute IRCCS E. Medea
Bosisio Parini, Lecco, Italy
Countries
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References
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Corti C, Papini M, Strazzer S, Borgatti R, Romaniello R, Poggi G, Storm FA, Urgesi C, Jansari A, Wade SL, Bardoni A. 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. JMIR Res Protoc. 2025 Feb 21;14:e64178. doi: 10.2196/64178.
Other Identifiers
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843
Identifier Type: -
Identifier Source: org_study_id
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