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Completed

NCT Number: NCT05169788

Rehabilitation Through the Italian Version of the Teen Online Problem-Solving (TOPS) Program

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.

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Key information

Conditions

Neurological Diseases or Conditions

Age range

11 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scientific Institute IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • history of abuse
  • familiarity for psychiatric hospitalization

Treatment and study plan

Teen On-line Problem Solving

Device

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 names: TOPS

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - baseline

    Time frame: baseline (immediately pre-training)

    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.

  2. Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - change at 6 months

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

    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.

  3. Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - change at 12 months

    Time frame: post-training (approximatively at month 12)

    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.

  4. Child Behavior Checklist 6-18 (CBCL 6-18) - baseline

    Time frame: baseline (immediately pre-training)

    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 Diagnostic and Statistical Manual of Mental Disorders(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.

  5. Child Behavior Checklist 6-18 (CBCL 6-18) - change at 6 months

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

    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.

  6. Child Behavior Checklist 6-18 (CBCL 6-18) - change at 12 months

    Time frame: post-training (approximatively at month 12)

    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.

  7. Youth Self-Report 11-18 (YSR 11-18) - baseline

    Time frame: baseline (immediately pre-training)

    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.

  8. Youth Self-Report 11-18 (YSR 11-18) - change at 6 months

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

    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.

  9. Youth Self-Report 11-18 (YSR 11-18) - change at 12 months

    Time frame: post-training (approximatively at month 12)

    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.

  10. Back Anxiety Inventory (BAI) - baseline

    Time frame: baseline (immediately pre-training)

    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.

  11. Back Anxiety Inventory (BAI) - change at 6 months

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

    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.

  12. Back Anxiety Inventory (BAI) - change at 12 months

    Time frame: post-training (approximatively at month 12)

    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.

  13. Symptom Checklist 90 (SCL-90) - baseline

    Time frame: baseline (immediately pre-training)

    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.

  14. Symptom Checklist 90 (SCL-90) - change at 6 months

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

    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.

  15. Symptom Checklist 90 (SCL-90) - change at 12 months

    Time frame: post-training (approximatively at month 12)

    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.

  16. Parenting Stress Index (PSI) - Short Form - baseline

    Time frame: baseline (immediately pre-training)

    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.

  17. Parenting Stress Index (PSI) - Short Form - change at 6 months

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

    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.

  18. Parenting Stress Index (PSI) - Short Form - change at 12 months

    Time frame: post-training (approximatively at month 12)

    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.

  19. Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - baseline

    Time frame: baseline (immediately pre-training)

    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.

  20. Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - change at 6 months

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

    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.

  21. Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - change at 12 months

    Time frame: post-training (approximatively at month 12)

    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.

  22. A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - baseline

    Time frame: baseline (immediately pre-training)

    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.

  23. A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - change at 6 months

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

    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.

  24. A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - change at 12 months

    Time frame: post-training (approximatively at month 12)

    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.

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Registry information

Official study title

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

Acronym: TOPS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2021
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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