Congenital DisordersTOPSNCT04293705
Congenital Disability and Rehabilitation: the TOPS Program
A study testing Teen On-line Problem Solving in people with Congenital Disorders, run by IRCCS Eugenio Medea at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 11 to 19 years
- Conditions the study is for
- Congenital Disorders
- What is being tested?
- Teen On-line Problem Solving
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 16 Feb 2018to 27 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of congenital disability due to brain malformation/syndrome
Who cannot join
- history of abuse
- familiarity for psychiatric hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Congenital Disability and Rehabilitation of Cognitive and Behavioral Difficulties by Using 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 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.
Read the 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.
- Conditions
- Congenital Disorders
- Being tested
- Teen On-line Problem Solving
- Keywords
- Congenital Disorders
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teen On-line Problem SolvingDevice
Also called TOPS
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.
| Study group | Role | What they receive |
|---|---|---|
| regular TOPS group | Experimental | Patients are required to perform the regular TOPS program, composed of 10 core sessions and other eventual supplementary sessions. In addition, biweekly Google Meet sessions with a cognitive-behavioral psychotherapist are scheduled, with the aim to monitor patients' activities on problem-solving related to the TOPS program contents and the problem solving process in real life. The program has a specific focus on problem-solving, executive functions, behavioral strategies and social skills. Receives: Device: Teen On-line Problem Solving |
| modified TOPS group | Active comparator | Patients are required to perform the modified TOPS program, composed of 10 sessions focused only on health and wellness contents. Thus, this program does not include contents on problem-solving, executive functions, behavioral strategies and social skills, representing a low cognitively simulating activity. Biweekly Google Meet sessions with a cognitive-behavioral psychotherapist are scheduled, with the aim of monitoring training adherence and discuss the program's contents. Receives: Device: Teen On-line Problem Solving |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (immediately pre-training)
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.
Measured: post-training (approximatively at month 6)
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.
Measured: follow-up (approximatively at month 12)
Secondary outcomes (24)
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.
Measured: baseline (immediately pre-training)
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.
Measured: post-training (approximatively at month 6)
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.
Measured: post-training (approximatively at month 12)
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.
Measured: baseline (immediately pre-training)
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.
Measured: post-training (approximatively at month 6)
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.
Measured: post-training (approximatively at month 12)
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.
Measured: baseline (immediately pre-training)
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.
Measured: post-training (approximatively at month 6)
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.
Measured: post-training (approximatively at month 12)
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.
Measured: baseline (immediately pre-training)
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.
Measured: post-training (approximatively at month 6)
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.
Measured: post-training (approximatively at month 12)
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.
Measured: baseline (immediately pre-training)
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.
Measured: post-training (approximatively at month 6)
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.
Measured: post-training (approximatively at month 12)
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.
Measured: baseline (immediately pre-training)
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.
Measured: post-training (approximatively at month 6)
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.
Measured: post-training (approximatively at month 12)
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.
Measured: baseline (immediately pre-training)
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.
Measured: post-training (approximatively at month 6)
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.
Measured: post-training (approximatively at month 12)
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.
Measured: baseline (immediately pre-training)
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.
Measured: post-training (approximatively at month 6)
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.
Measured: post-training (approximatively at month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start16 Feb 2018
- Primary completion27 Jan 2021
- Study completion27 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Group 1 performs the regular TOPS intervention on problem-solving and executive function-related behaviors, while Group 2, serving as active control group, performs a modified version of the TOPS including only sessions on health and wellness but no contents on problem-solving and executive function-related behaviors.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293705
- Sponsor's protocol ID
- 350
- Acronym
- TOPS
- Status last verified
- Jun 2021
- First submitted
- 25 Feb 2020
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital Disability and Rehabilitation of Cognitive and Behavioral Difficulties by Using the Teen Online Problem-Solving (TOPS) Program.
- ClinicalTrials.gov ID
- NCT04293705
- Acronym / sponsor ID
- TOPS / 350
- Conditions
- Congenital Disorders
- Keywords
- Congenital Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1 performs the regular TOPS intervention on problem-solving and executive function-related behaviors, while Group 2, serving as active control group, performs a modified version of the TOPS including only sessions on health and wellness but no contents on problem-solving and executive function-related behaviors.
| Arm | Type | Receives |
|---|---|---|
| regular TOPS group | Experimental | Device: Teen On-line Problem SolvingPatients are required to perform the regular TOPS program, composed of 10 core sessions and other eventual supplementary sessions. In addition, biweekly Google Meet sessions with a cognitive-behavioral psychotherapist are scheduled, with the aim to monitor patients' activities on problem-solving related to the TOPS program contents and the problem solving process in real life. The program has a specific focus on problem-solving, executive functions, behavioral strategies and social skills. |
| modified TOPS group | Active comparator | Device: Teen On-line Problem SolvingPatients are required to perform the modified TOPS program, composed of 10 sessions focused only on health and wellness contents. Thus, this program does not include contents on problem-solving, executive functions, behavioral strategies and social skills, representing a low cognitively simulating activity. Biweekly Google Meet sessions with a cognitive-behavioral psychotherapist are scheduled, with the aim of monitoring training adherence and discuss the program's contents. |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- diagnosis of congenital disability due to brain malformation/syndrome
Key exclusion criteria (2 listed)
- history of abuse
- familiarity for psychiatric hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teen On-line Problem SolvingAlso: TOPSThe 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. | Device | modified TOPS group, regular TOPS group |
Primary outcome
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 (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.
24 secondary outcomes
Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - baseline
Time frame: baseline (immediately pre-training)
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)
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)
Child Behavior Checklist 6-18 (CBCL 6-18) - baseline
Time frame: baseline (immediately pre-training)
Child Behavior Checklist 6-18 (CBCL 6-18) - change at 6 months
Time frame: post-training (approximatively at month 6)
Child Behavior Checklist 6-18 (CBCL 6-18) - change at 12 months
Time frame: post-training (approximatively at month 12)
Youth Self-Report 11-18 (YSR 11-18) - baseline
Time frame: baseline (immediately pre-training)
Youth Self-Report 11-18 (YSR 11-18) - change at 6 months
Time frame: post-training (approximatively at month 6)
Youth Self-Report 11-18 (YSR 11-18) - change at 12 months
Time frame: post-training (approximatively at month 12)
Back Anxiety Inventory (BAI) - baseline
Time frame: baseline (immediately pre-training)
Back Anxiety Inventory (BAI) - change at 6 months
Time frame: post-training (approximatively at month 6)
Back Anxiety Inventory (BAI) - change at 12 months
Time frame: post-training (approximatively at month 12)
Symptom Checklist 90 (SCL-90) - baseline
Time frame: baseline (immediately pre-training)
Symptom Checklist 90 (SCL-90) - change at 6 months
Time frame: post-training (approximatively at month 6)
Symptom Checklist 90 (SCL-90) - change at 12 months
Time frame: post-training (approximatively at month 12)
Parenting Stress Index (PSI) - Short Form - baseline
Time frame: baseline (immediately pre-training)
Parenting Stress Index (PSI) - Short Form - change at 6 months
Time frame: post-training (approximatively at month 6)
Parenting Stress Index (PSI) - Short Form - change at 12 months
Time frame: post-training (approximatively at month 12)
Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - baseline
Time frame: baseline (immediately pre-training)
Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - change at 6 months
Time frame: post-training (approximatively at month 6)
Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - change at 12 months
Time frame: post-training (approximatively at month 12)
A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - baseline
Time frame: baseline (immediately pre-training)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teen On-line Problem Solving in people with Congenital Disorders, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - parent form - baseline (time frame: baseline (immediately pre-training)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.