Congenital Disability and Rehabilitation: the TOPS Program

NCT04293705 | Completed

• 1 other identifier: 350
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Disorders

Keywords

Congenital Disorders

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (24)

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

  baseline (immediately pre-training)

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

  post-training (approximatively at month 6)

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

  post-training (approximatively at month 12)

• Child Behavior Checklist 6-18 (CBCL 6-18) - baseline

  baseline (immediately pre-training)

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

  post-training (approximatively at month 6)

Study Arms (2)

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.

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.

Device: Teen On-line Problem Solving

Interventions

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.

Also known as: TOPS

modified TOPS group; regular TOPS group

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• diagnosis of congenital disability due to brain malformation/syndrome

You may not qualify if:

• history of abuse
• familiarity for psychiatric hospitalization

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

Scientific Institute IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors and participants are blinded with respect to group assignment, as both Group 1 and Group 2 use the TOPS program platform, even though with different contents.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 3, 2020
• Study Start: February 16, 2018
• Primary Completion: January 27, 2021
• Study Completion: January 27, 2021
• Last Updated: May 2, 2025

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)