Congenital Disability and Rehabilitation: the TOPS Program

IRCCS Eugenio Medea

Status: Completed

Conditions: Congenital Disorders

Treatments: Device: Teen On-line Problem Solving

Study type: Interventional

Funder types: Other

Identifiers

NCT04293705

350

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 11 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of congenital disability due to brain malformation/syndrome

Exclusion criteria

• history of abuse
• familiarity for psychiatric hospitalization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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42 participants in 2 patient groups

regular TOPS group

Experimental group

Description:

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.

Treatment:

Device: Teen On-line Problem Solving

modified TOPS group

Active Comparator group

Description:

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.

Treatment:

Device: Teen On-line Problem Solving