Clinical trial NCT04293705: Congenital Disability and Rehabilitation: the TOPS Program
Official title: Congenital Disability and Rehabilitation of Cognitive and Behavioral Difficulties by Using the Teen Online Problem-Solving (TOPS) Program.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Disorders
Keywords: Congenital Disorders
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 42
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* diagnosis of congenital disability due to brain malformation/syndrome

Exclusion Criteria:

* history of abuse
* familiarity for psychiatric hospitalization

Primary outcomes:
measure: Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - parent form - baseline
timeFrame: baseline (immediately pre-training)
measure: Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - parent form - change at 6 months (immediately post-training)
timeFrame: post-training (approximatively at month 6)
measure: 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)
timeFrame: follow-up (approximatively at month 12)
Secondary outcomes:
measure: Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - baseline
timeFrame: baseline (immediately pre-training)
measure: Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - change at 6 months
timeFrame: post-training (approximatively at month 6)
measure: Behavior Rating Inventory of Executive Function Second Edition (BRIEF 2) - self report form - change at 12 months
timeFrame: post-training (approximatively at month 12)
measure: Child Behavior Checklist 6-18 (CBCL 6-18) - baseline
timeFrame: baseline (immediately pre-training)
measure: Child Behavior Checklist 6-18 (CBCL 6-18) - change at 6 months
timeFrame: post-training (approximatively at month 6)
measure: Child Behavior Checklist 6-18 (CBCL 6-18) - change at 12 months
timeFrame: post-training (approximatively at month 12)
measure: Youth Self-Report 11-18 (YSR 11-18) - baseline
timeFrame: baseline (immediately pre-training)
measure: Youth Self-Report 11-18 (YSR 11-18) - change at 6 months
timeFrame: post-training (approximatively at month 6)
measure: Youth Self-Report 11-18 (YSR 11-18) - change at 12 months
timeFrame: post-training (approximatively at month 12)
measure: Back Anxiety Inventory (BAI) - baseline
timeFrame: baseline (immediately pre-training)
measure: Back Anxiety Inventory (BAI) - change at 6 months
timeFrame: post-training (approximatively at month 6)
measure: Back Anxiety Inventory (BAI) - change at 12 months
timeFrame: post-training (approximatively at month 12)
measure: Symptom Checklist 90 (SCL-90) - baseline
timeFrame: baseline (immediately pre-training)
measure: Symptom Checklist 90 (SCL-90) - change at 6 months
timeFrame: post-training (approximatively at month 6)
measure: Symptom Checklist 90 (SCL-90) - change at 12 months
timeFrame: post-training (approximatively at month 12)
measure: Parenting Stress Index (PSI) - Short Form - baseline
timeFrame: baseline (immediately pre-training)
measure: Parenting Stress Index (PSI) - Short Form - change at 6 months
timeFrame: post-training (approximatively at month 6)
measure: Parenting Stress Index (PSI) - Short Form - change at 12 months
timeFrame: post-training (approximatively at month 12)
measure: Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - baseline
timeFrame: baseline (immediately pre-training)
measure: Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - change at 6 months
timeFrame: post-training (approximatively at month 6)
measure: Jansari Assessment of Executive Functioning - Adolescents (JEF-A) - change at 12 months
timeFrame: post-training (approximatively at month 12)
measure: A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - baseline
timeFrame: baseline (immediately pre-training)
measure: A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - change at 6 months
timeFrame: post-training (approximatively at month 6)
measure: A Developmental NEuroPSYchological Assessment-II (NEPSY-II) (Theory of Mind and Emotion Recognition subscales) - change at 12 months
timeFrame: post-training (approximatively at month 12)
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Scientific Institute IRCCS E. Medea
state: Lecco
Study officials:
References: