Congenital Disability and Rehabilitation: the TOPS Program

Congenital Disorders Clinical Trial

— TOPS  

Official title:

Congenital Disability and Rehabilitation of Cognitive and Behavioral Difficulties by Using the Teen Online Problem-Solving (TOPS) Program.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04293705
• Other study ID #: 350
• Status: Completed
• Phase: N/A
• Start date: February 16, 2018
• Est. completion date: January 27, 2021

Study information

• Verified date: June 2021
• Source: IRCCS Eugenio Medea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 27, 2021
• Est. primary completion date: January 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 19 Years

Eligibility

Inclusion Criteria:

• diagnosis of congenital disability due to brain malformation/syndrome

Exclusion Criteria:

• history of abuse

• familiarity for psychiatric hospitalization

Related Conditions & MeSH terms

• Congenital Disorders

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Italy	Scientific Institute IRCCS E. Medea	Bosisio Parini	Lecco

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - parent form - baseline	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.	baseline (immediately pre-training)
Primary	Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - parent form - change at 6 months (immediately post-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.	post-training (approximatively at month 6)
Primary	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)	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.	follow-up (approximatively at month 12)
Secondary	Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - baseline	The BRIEF questionnaire is aimed at assessing self-reported executive functioning at home and school of adolescents aged 11-18 years and contains 55 items in different clinical scales and validity scales. Raw scores of the global scale range from 55 to 165. T scores (M = 50, SD = 10) are used to interpret the level of executive functioning. Higher scores mean a worse outcome.	baseline (immediately pre-training)
Secondary	Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - change at 6 months	The BRIEF questionnaire is aimed at assessing self-reported executive functioning at home and school of adolescents aged 11-18 years and contains 55 items in different clinical scales and validity scales. Raw scores of the global scale range from 55 to 165. T scores (M = 50, SD = 10) are used to interpret the level of executive functioning. Higher scores mean a worse outcome.	post-training (approximatively at month 6)
Secondary	Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - change at 12 months	The BRIEF questionnaire is aimed at assessing self-reported executive functioning at home and school of adolescents aged 11-18 years and contains 55 items in different clinical scales and validity scales. Raw scores of the global scale range from 55 to 165. T scores (M = 50, SD = 10) are used to interpret the level of executive functioning. Higher scores mean a worse outcome.	post-training (approximatively at month 12)
Secondary	Child Behavior Checklist 6-18 (CBCL 6-18) - baseline	The CBCL 6-18 is aimed at assessing psychological adjustment and behavioral functioning of children, as rated by parents. This instrument provides a total score, an internalizing score and an externalizing score, together with 8 syndrome scale scores and 6 DSM-oriented scale scores. It contains 113 items. Raw scores of the Total Problems Scale range from 0 to 226. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.	baseline (immediately pre-training)
Secondary	Child Behavior Checklist 6-18 (CBCL 6-18) - change at 6 months	The CBCL 6-18 is aimed at assessing psychological adjustment and behavioral functioning of children, as rated by parents. This instrument provides a total score, an internalizing score and an externalizing score, together with 8 syndrome scale scores and 6 DSM-oriented scale scores. It contains 113 items. Raw scores of the Total Problems Scale range from 0 to 226. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.	post-training (approximatively at month 6)
Secondary	Child Behavior Checklist 6-18 (CBCL 6-18) - change at 12 months	The CBCL 6-18 is aimed at assessing psychological adjustment and behavioral functioning of children, as rated by parents. This instrument provides a total score, an internalizing score and an externalizing score, together with 8 syndrome scale scores and 6 DSM-oriented scale scores. It contains 113 items. Raw scores of the Total Problems Scale range from 0 to 226. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.	post-training (approximatively at month 12)
Secondary	Youth Self-Report 11-18 (YSR 11-18) - baseline	YSR 11-18 is aimed at assessing self-reported psychological adjustment and behavioral functioning of adolescents aged 11-18 years. This instrument provides a total score, an internalizing score and an externalizing score, together with eight empirically based syndromes and DSM-oriented scales. It contains 112 items. Raw scores of the Total Problems Scale range from 0 to 224. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.	baseline (immediately pre-training)
Secondary	Youth Self-Report 11-18 (YSR 11-18) - change at 6 months	YSR 11-18 is aimed at assessing self-reported psychological adjustment and behavioral functioning of adolescents aged 11-18 years. This instrument provides a total score, an internalizing score and an externalizing score, together with eight empirically based syndromes and DSM-oriented scales. It contains 112 items. Raw scores of the Total Problems Scale range from 0 to 224. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.	post-training (approximatively at month 6)
Secondary	Youth Self-Report 11-18 (YSR 11-18) - change at 12 months	YSR 11-18 is aimed at assessing self-reported psychological adjustment and behavioral functioning of adolescents aged 11-18 years. This instrument provides a total score, an internalizing score and an externalizing score, together with eight empirically based syndromes and DSM-oriented scales. It contains 112 items. Raw scores of the Total Problems Scale range from 0 to 224. T scores (M = 50, SD = 10) are used to interpret the level of behavioral functioning. Higher scores mean a worse outcome.	post-training (approximatively at month 12)
Secondary	Back Anxiety Inventory (BAI) - baseline	BAI is a 21-item questionnaire aimed at assessing state and trait anxiety. In this study the questionnaire is administered to parents to evaluate their psychological functioning. The total score is calculated by finding the sum of the 21 items (4-point Likert scale ranging from 0 to 3), with a minimum score of 0 and a maximum score of 108. Higher scores mean a worse outcome. Score of 0-21 indicates low anxiety; score of 22-35 indicates moderate anxiety; score of 36 and above (maximum: 108) indicates potentially concerning levels of anxiety.	baseline (immediately pre-training)
Secondary	Back Anxiety Inventory (BAI) - change at 6 months	BAI is a 21-item questionnaire aimed at assessing state and trait anxiety. In this study the questionnaire is administered to parents to evaluate their psychological functioning. The total score is calculated by finding the sum of the 21 items (4-point Likert scale ranging from 0 to 3), with a minimum score of 0 and a maximum score of 108. Higher scores mean a worse outcome. Score of 0-21 indicates low anxiety; score of 22-35 indicates moderate anxiety; score of 36 and above (maximum: 108) indicates potentially concerning levels of anxiety.	post-training (approximatively at month 6)
Secondary	Back Anxiety Inventory (BAI) - change at 12 months	BAI is a 21-item questionnaire aimed at assessing state and trait anxiety. In this study the questionnaire is administered to parents to evaluate their psychological functioning. The total score is calculated by finding the sum of the 21 items (4-point Likert scale ranging from 0 to 3), with a minimum score of 0 and a maximum score of 108. Higher scores mean a worse outcome. Score of 0-21 indicates low anxiety; score of 22-35 indicates moderate anxiety; score of 36 and above (maximum: 108) indicates potentially concerning levels of anxiety.	post-training (approximatively at month 12)
Secondary	Symptom Checklist 90 (SCL-90) - baseline	The SCL-90 is a self-report questionnaire aimed at measuring psychiatric symptom intensity on nine different subscales. The 90 items are scored on a five-point Likert scale (ranging from 0 to 4), indicating the rate of occurrence of the symptoms during the last 7 days. In this study the questionnaire is administered to parents to assess parental psychological distress, by considering the Global Severity Index (GSI). Raw scores of the GSI, which are calculated as the average score of the 90 items of the questionnaire, range from 0 to 360. The final score is reported as T score (M = 50 SD = 10). Higher scores indicate higher distress. Consistent with the recommendations of Derogatis (1994), a T score at or above 63 on the GSI indicates the clinical range.	baseline (immediately pre-training)
Secondary	Symptom Checklist 90 (SCL-90) - change at 6 months	The SCL-90 is a self-report questionnaire aimed at measuring psychiatric symptom intensity on nine different subscales. The 90 items are scored on a five-point Likert scale (ranging from 0 to 4), indicating the rate of occurrence of the symptoms during the last 7 days. In this study the questionnaire is administered to parents to assess parental psychological distress, by considering the Global Severity Index (GSI). Raw scores of the GSI, which are calculated as the average score of the 90 items of the questionnaire, range from 0 to 360. The final score is reported as T score (M = 50 SD = 10). Higher scores indicate higher distress. Consistent with the recommendations of Derogatis (1994), a T score at or above 63 on the GSI indicates the clinical range.	post-training (approximatively at month 6)
Secondary	Symptom Checklist 90 (SCL-90) - change at 12 months	The SCL-90 is a self-report questionnaire aimed at measuring psychiatric symptom intensity on nine different subscales. The 90 items are scored on a five-point Likert scale (ranging from 0 to 4), indicating the rate of occurrence of the symptoms during the last 7 days. In this study the questionnaire is administered to parents to assess parental psychological distress, by considering the Global Severity Index (GSI). Raw scores of the GSI, which are calculated as the average score of the 90 items of the questionnaire, range from 0 to 360. The final score is reported as T score (M = 50 SD = 10). Higher scores indicate higher distress. Consistent with the recommendations of Derogatis (1994), a T score at or above 63 on the GSI indicates the clinical range.	post-training (approximatively at month 12)
Secondary	Parenting Stress Index (PSI) - Short Form - baseline	PSI - Short Form is a 36-item questionnaire aimed at assessing levels of stress associated with parenting. The 36 items are scored on a five-point Likert scale. PSI - Short Form is directly administered to parents. A global score (PSI-total) and three subscales, namely Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI) and Difficult Child (DC), are provided. The clinical cut-off of PSI-total is established at 90 (Abidin 2008). Higher scores indicate higher distress.	baseline (immediately pre-training)
Secondary	Parenting Stress Index (PSI) - Short Form - change at 6 months	PSI - Short Form is a 36-item questionnaire aimed at assessing levels of stress associated with parenting. The 36 items are scored on a five-point Likert scale. PSI - Short Form is directly administered to parents. A global score (PSI-total) and three subscales, namely Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI) and Difficult Child (DC), are provided. The clinical cut-off of PSI-total is established at 90 (Abidin 2008). Higher scores indicate higher distress.	post-training (approximatively at month 6)
Secondary	Parenting Stress Index (PSI) - Short Form - change at 12 months	PSI - Short Form is a 36-item questionnaire aimed at assessing levels of stress associated with parenting. The 36 items are scored on a five-point Likert scale. PSI - Short Form is directly administered to parents. A global score (PSI-total) and three subscales, namely Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI) and Difficult Child (DC), are provided. The clinical cut-off of PSI-total is established at 90 (Abidin 2008). Higher scores indicate higher distress.	post-training (approximatively at month 12)
Secondary	Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - baseline	JEF-A is an ecologically-valid computerized assessment using non-immersive virtual reality aimed at evaluating executive functions in adolescents. It is a performance-based assessment. Participants are asked to plan, set up and run a birthday party through the completion of 16 tasks resembling real-world activities. All tasks are scored on a 3-point scale: 0 for failure, 1 for a partial or nonoptimal completion, and 2 for satisfactory completion. The final raw score ranges from 0 to 32. Higher scores mean a better executive functioning.	baseline (immediately pre-training)
Secondary	Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - change at 6 months	JEF-A is an ecologically-valid computerized assessment using non-immersive virtual reality aimed at evaluating executive functions in adolescents. It is a performance-based assessment. Participants are asked to plan, set up and run a birthday party through the completion of 16 tasks resembling real-world activities. All tasks are scored on a 3-point scale: 0 for failure, 1 for a partial or nonoptimal completion, and 2 for satisfactory completion. The final raw score ranges from 0 to 32. Higher scores mean a better executive functioning.	post-training (approximatively at month 6)
Secondary	Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - change at 12 months	JEF-A is an ecologically-valid computerized assessment using non-immersive virtual reality aimed at evaluating executive functions in adolescents. It is a performance-based assessment. Participants are asked to plan, set up and run a birthday party through the completion of 16 tasks resembling real-world activities. All tasks are scored on a 3-point scale: 0 for failure, 1 for a partial or nonoptimal completion, and 2 for satisfactory completion. The final raw score ranges from 0 to 32. Higher scores mean a better executive functioning.	post-training (approximatively at month 12)
Secondary	A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - baseline	The Theory of Mind and Affect Recognition subscales of NEPSY II are performance-based subtests aimed at evaluating social perception. They are administered to adolescents. Theory of Mind subscale-part A raw scores range from 0 to 17, Theory of Mind subscale-part b raw scores range from 0 to 8. Theory of Mind total subscale raw scores range from 0 to 25. Affect Recognition subscale raw scores range from 0 to 35. Raw scores are converted in scaled scores ranging from 1 to 19. Higher scores mean better outcomes.	baseline (immediately pre-training)
Secondary	A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - change at 6 months	The Theory of Mind and Affect Recognition subscales of NEPSY II are performance-based subtests aimed at evaluating social perception. They are administered to adolescents. Theory of Mind subscale-part A raw scores range from 0 to 17, Theory of Mind subscale-part b raw scores range from 0 to 8. Theory of Mind total subscale raw scores range from 0 to 25. Affect Recognition subscale raw scores range from 0 to 35. Raw scores are converted in scaled scores ranging from 1 to 19. Higher scores mean better outcomes.	post-training (approximatively at month 6)
Secondary	A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - change at 12 months	The Theory of Mind and Affect Recognition subscales of NEPSY II are performance-based subtests aimed at evaluating social perception. They are administered to adolescents. Theory of Mind subscale-part A raw scores range from 0 to 17, Theory of Mind subscale-part b raw scores range from 0 to 8. Theory of Mind total subscale raw scores range from 0 to 25. Affect Recognition subscale raw scores range from 0 to 35. Raw scores are converted in scaled scores ranging from 1 to 19. Higher scores mean better outcomes.	post-training (approximatively at month 12)