Rehabilitation of Executive Functions and Social Skills in Adolescents With Neurological Condition by Using the Italian Version of the Teen Online Problem-Solving (TOPS) Program

IRCCS Eugenio Medea1 site in 1 country42 target enrollmentFebruary 26, 2021

ConditionsNeurological Diseases or Conditions

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neurological Diseases or Conditions
Sponsor: IRCCS Eugenio Medea
Enrollment: 42
Locations: 1
Primary Endpoint: Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - parent form - baseline
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

February 26, 2021

End Date

February 28, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

IRCCS Eugenio Medea

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•diagnosis of neurological condition (non-progressive aquired brain injury, brain tumor, epilepsy etc.)

Exclusion Criteria

•history of abuse
•familiarity for psychiatric hospitalization

Outcomes

Primary Outcomes

Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - parent form - baseline

Time Frame: baseline (immediately pre-training)

The BRIEF questionnaire is aimed at assessing executive functioning at home and school and contains 63 items in different clinical scales and validity scales. The questionnaire is administered to parents, which have to rate the frequency of dysexecutive problems of their children on a 3-point Likert Scale. Raw scores of the global scale range from 63 to 189. T scores (M = 50, SD = 10) are used to interpret the level of executive functioning. Higher scores mean a worse outcome.

Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - parent form - change at 6 months (immediately post-training)

Time Frame: post-training (approximatively at month 6)

The BRIEF questionnaire is aimed at assessing executive functioning at home and school and contains 63 items in different clinical scales and validity scales. The questionnaire is administered to parents, which have to rate the frequency of dysexecutive problems of their children on a 3-point Likert Scale. Raw scores of the global scale range from 63 to 189. T scores (Mean-M = 50, Standard Deviation-SD = 10) are used to interpret the level of executive functioning. Higher scores mean a worse outcome.

Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - parent form - change at 12 months (follow-up at 6 months after the end of the training)

Time Frame: follow-up (approximatively at month 12)

Secondary Outcomes

Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - baseline(baseline (immediately pre-training))
Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - change at 6 months(post-training (approximatively at month 6))
Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - change at 12 months(post-training (approximatively at month 12))
Child Behavior Checklist 6-18 (CBCL 6-18) - change at 6 months(post-training (approximatively at month 6))
Child Behavior Checklist 6-18 (CBCL 6-18) - change at 12 months(post-training (approximatively at month 12))
Child Behavior Checklist 6-18 (CBCL 6-18) - baseline(baseline (immediately pre-training))
Youth Self-Report 11-18 (YSR 11-18) - baseline(baseline (immediately pre-training))
Youth Self-Report 11-18 (YSR 11-18) - change at 6 months(post-training (approximatively at month 6))
Youth Self-Report 11-18 (YSR 11-18) - change at 12 months(post-training (approximatively at month 12))
Back Anxiety Inventory (BAI) - baseline(baseline (immediately pre-training))
Back Anxiety Inventory (BAI) - change at 6 months(post-training (approximatively at month 6))
Back Anxiety Inventory (BAI) - change at 12 months(post-training (approximatively at month 12))
Symptom Checklist 90 (SCL-90) - change at 6 months(post-training (approximatively at month 6))
Symptom Checklist 90 (SCL-90) - baseline(baseline (immediately pre-training))
Symptom Checklist 90 (SCL-90) - change at 12 months(post-training (approximatively at month 12))
A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - baseline(baseline (immediately pre-training))
Parenting Stress Index (PSI) - Short Form - baseline(baseline (immediately pre-training))
Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - change at 6 months(post-training (approximatively at month 6))
Parenting Stress Index (PSI) - Short Form - change at 6 months(post-training (approximatively at month 6))
Parenting Stress Index (PSI) - Short Form - change at 12 months(post-training (approximatively at month 12))
Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - baseline(baseline (immediately pre-training))
Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - change at 12 months(post-training (approximatively at month 12))
A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - change at 6 months(post-training (approximatively at month 6))
A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - change at 12 months(post-training (approximatively at month 12))