Congenital Disability and Rehabilitation: the TOPS Program
Condition: Congenital Disorders
Study type: Interventional

Summary: 
      The study aims at evaluating the feasibility and the efficacy of the Teen On-line Problem
      Solving program (TOPS) in improving executive functioning and behavior problems in
      adolescents aged 11-19 years with congenital disability due to brain malformation/syndrome.

      In order to control for placebo effects, participants are randomized into two intervention
      conditions. Group 1 performs the regular version of the TOPS, while Group 2 performs a
      modified version containing no activities on executive functions, behavioral strategies and
      social skills.
    

Detailed description: 
      Adolescents with congenital brain malformation/syndrome often present with executive
      dysfunction and behavioral and social problems. Ad hoc rehabilitation may significantly
      ameliorate such difficulties. With this aim, the Teen On-line Problem-Solving program (TOPS)
      could represent a suitable opportunity of intervention, as it aims at helping children to
      improve executive and behavioral functioning. The program consists of a web-based platform
      composed of 10 core sessions and eventual supplementary sessions, providing information and
      activities on executive functioning, behavioral strategies, social skills and injury-related
      issues and health and wellness. The program is delivered remotely, with patients performing
      the intervention at home, together with their families. Biweekly Google Meet sessions with a
      cognitive-behavioral psychotherapist are scheduled along the entire duration of the
      intervention to monitor the activities related to the program and the real-life
      problem-solving process that patients are required to perform during the intervention.

      Assessment of executive functions and behavioral problems is conducted before and after the
      training (immediate post training assessment and follow-up assessment 6 months after the end
      of the training), in order to investigate the presence of significant changes after the
      intervention. Both questionnaires and performance-based measures are used.

      Participants are randomized into two groups: Group 1 performs the regular version of the
      TOPS, while Group 2 performs a modified version containing no activities on executive
      functions, behavioral strategies and social skills.

      Based on the average effect of TOPS program reported by a meta-analysis available in the
      literature (Corti et al., 2019; Hedge's g = 0.39) we estimated a small-to-moderate effect
      size of f =0.2 (f was calculated based on Hedge's g value). Power analysis was conducted by
      using GPower3 software. Assuming a correlation of 0.50 between repeated measures and setting
      the alfa level at P < 0.05, a sample size of 21 subjects per group is required to obtain 80%
      of power with our 2 groups x 3 time points design.
    

Intervention name(s): Teen On-line Problem Solving
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): TOPS
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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 (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Congenital Disorders