Congenital Disability and Rehabilitation of Cognitive and Behavioral Difficulties by Using the Teen Online Problem-Solving (TOPS) Program.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Disorders
- 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
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 aged 11-19 years with congenital disability due to brain malformation/syndrome.
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 congenital brain malformation/syndrome 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 children 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 and 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •diagnosis of congenital disability due to brain malformation/syndrome
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 12 months (follow-up at 6 months after the end of the training)
Time Frame: follow-up (approximatively at month 12)
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 (M = 50, SD = 10) are used to interpret the level of executive functioning. Higher scores mean a worse outcome.
Secondary Outcomes
- 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) - baseline(baseline (immediately pre-training))
- Youth Self-Report 11-18 (YSR 11-18) - baseline(baseline (immediately pre-training))
- Back Anxiety Inventory (BAI) - 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))
- Youth Self-Report 11-18 (YSR 11-18) - 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))
- Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - 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))
- Youth Self-Report 11-18 (YSR 11-18) - change at 6 months(post-training (approximatively at month 6))
- Back Anxiety Inventory (BAI) - baseline(baseline (immediately pre-training))
- Symptom Checklist 90 (SCL-90) - change at 12 months(post-training (approximatively at month 12))
- Parenting Stress Index (PSI) - Short Form - baseline(baseline (immediately pre-training))
- Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - baseline(baseline (immediately pre-training))
- Back Anxiety Inventory (BAI) - change at 6 months(post-training (approximatively at month 6))
- Symptom Checklist 90 (SCL-90) - 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) - change at 6 months(post-training (approximatively at month 6))
- Symptom Checklist 90 (SCL-90) - baseline(baseline (immediately pre-training))
- Parenting Stress Index (PSI) - Short Form - change at 6 months(post-training (approximatively at month 6))
- A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - baseline(baseline (immediately pre-training))
- 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))