Clinical Trials Logo

Clinical Trial Summary

The study aims at evaluating the feasibility and the efficacy of the Teen On-line Problem Solving program (TOPS) in improving executive functioning and behavior problems in adolescents with neurological condition aged 11-19 years. 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.


Clinical Trial Description

Adolescents with neurological condition often present with executive dysfunction and behavioral and social problems. Ad hoc rehabilitation may significantly ameliorate such difficulties. With this aim, the Teen On-line Problem-Solving program (TOPS) could represent a suitable opportunity of intervention, as it aims at helping patients to improve executive and behavioral functioning. The program consists of a web-based platform composed of 10 core sessions and eventual supplementary sessions, providing information and activities on executive functioning, behavioral strategies, social skills. injury-related issues and health and wellness. The program is delivered remotely, with patients performing the intervention at home, together with their families. Biweekly Google Meet sessions with a cognitive-behavioral psychotherapist are scheduled along the entire duration of the intervention to monitor the activities related to the program and the real-life problem-solving process that patients are required to perform during the intervention. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05169788
Study type Interventional
Source IRCCS Eugenio Medea
Contact
Status Completed
Phase N/A
Start date February 26, 2021
Completion date February 28, 2023

See also
  Status Clinical Trial Phase
Terminated NCT03128086 - Weaning From Mechanical Ventilation in Neurological Patients N/A
Recruiting NCT04581577 - Perceptions of the Clinical and Psychosocial Impact of Covid-19 in Patients With Neuromuscular and Neurological Disorders
Active, not recruiting NCT05742087 - Neuropathy and Anti-GFAP Antibodies
Recruiting NCT05645003 - Transcranial Magnetic Stimulation Therapy in Neuropathic Painful Spinal Cord Injury Patients N/A
Withdrawn NCT04377425 - COVID-19 Prevalence and Cognitive Deficits in Neurological Patients
Withdrawn NCT01898975 - A Gray Zone Approach to Stroke Volume Variation Derived From NICOM N/A
Active, not recruiting NCT03480581 - Impact of Reverse vs. Forward ICARE Training Interventions N/A
Completed NCT04061616 - Transcultural Validation of the Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) in French: The PASIPD-Fr N/A
Recruiting NCT04706481 - Archival of Human Biological Samples in CU-Med Biobank
Recruiting NCT06450717 - IMPLEMENTATION OF A PILOT TELEREHABILITATION NETWORK IN PEDIATRIC PATIENTS WITH COMPLEX NEURODSABILITIES MedeaNeuroTelerehab-Net (MENTE.NET STUDY) N/A
Completed NCT03619642 - Reliability, Validity and Clinical Utility of a Robotic Assessment for Proprioception N/A
Recruiting NCT05526508 - Rebound Exercise in Neurological Disorders N/A
Recruiting NCT05086380 - Modulation of Sense of Agency With Non-invasive Brain Stimulation and Mindfulness-based Stress Reduction Therapy N/A
Recruiting NCT04866251 - Prevalence of Gag Reflex in Healthy Persons and Across Different Patient Groups and Its Relevance in Dysphagia Screening N/A
Not yet recruiting NCT05796037 - An Observational Study of Patients Living With Chronic Neurological Diseases
Recruiting NCT03777267 - Cereset Research Exploratory Study N/A
Completed NCT05097066 - Patterns and Outcomes of Neurosurgery in England Over a Five-year Period