EF Intervention in Children With Severe Congenital Heart Disease

Heart Defects, Congenital Clinical Trial

— E-FIT  

Official title:

Executive Function and Brain Development in Adolescents With Severe Congenital Heart Disease (Teen Heart Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05198583
• Other study ID #: Teen Heart Intervention
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: University Children's Hospital, Zurich
• Contact: Bea Latal, MD
• Phone: 001412667924
• Email: bea.latal[@]kispi.uzh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Survival rates of children with severe congenital heart disease (CHD) have increased with ongoing medical progress over the past decades. However, many children with CHD face academic challenges during adolescence, which are associated with executive dysfunction. Executive functions (EF), higher-order cognitive processes allowing goal-directed behavior, can be particularly affected in children with CHD. To improve EF in affected children, a specific EF intervention has been developed. The intervention lasts a total of 8 weeks and is structured in 3 modules. The first module consists of a weekly strategy training in which problems resulting from executive dysfunction are addressed. Online games form the second module. These are games implemented online to promote EF through play. The third module is also based on games: The families receive several board games to play together at home. This third module is voluntary. This intervention is tested on its feasibility. As the intervention was built in a patient centered manner, we expect it to be feasible, showing in a high adherence rate and satisfaction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 12 Years

Eligibility

Inclusion Criteria:

• Born with CHD
• Underwent cardiopulmonary bypass surgery
• No genetic syndrome detected, no known dysmorphic-syndrome
• Aged 10 to 12
• written informed consent of parents and verbal informed consent of children
• EF deficits showing in screening

Exclusion Criteria:

• Failure to provide a signed Informed Consent
• Heart surgery without cardiopulmonary bypass
• Heart surgery not performed in Switzerland
• Any genetic syndrome detected
• large cerebral lesions (stroke, HIE) or severely neurologically impaired as a result of a serious event

Related Conditions & MeSH terms

• Congenital Abnormalities
• Executive Dysfunction
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• E-Fit
The intervention lasts a total of 8 weeks and is structured in 3 modules. The first module consists of a weekly strategy training in which problems resulting from executive dysfunction are addressed. Online games form the second module. These are games implemented online to promote EF through play. The third module is also based on games: The families receive several board games to play together at home. This third module is voluntary.

Locations

Country	Name	City	State
Switzerland	Children's Hospital Zurich	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fun and cognitive demand	Subjective Feasibility, Fun and cognitive demand: the two questions "How fun was the training?" and "How much did you use your brain" are answered on a 5-point Likert scale (1 referring to not at all and 5 referring to very much). Both questions are treated as ordinal scaled and median and interquartile range will be reported.	5 minutes
Primary	Hulley's Feeling Scale	Subjective Feasibility, Affect 11-point single item bipolar scale (-5 referring to "very bad" and 5 referring to "very good"). The Hulley feeling scale is treated as ordinal scaled and median and interquartile range will be reported.	5 minutes
Primary	Acceptance and Feasibility scale	4-point Likert scale (1 referring to "don't agree at all" and 4 referring to "fully agree"). Treated as ordinal scaled and median and interquartile range, as well as percentages of persons who answered the items with 3 or 4, will be reported.	5 minutes
Primary	Completion rate (Objective Feasibility):	Frequency (amount of participants who completed the training)/(total amount of participants enrolled)	5 minutes
Secondary	Behavior Rating Inventory of Executive Function (BRIEF)	The BRIEF assesses Executive Functions Behavior in everyday life. The results will be be transformed into a categorical variable with results > 1 SD defined as abnormal (T-scale >= 60).	15 minutes
Secondary	Color word Interference Task (D-KEFS)	The D-KEFS Color-Word Interference Test is based on the classic Stroop task, which is primarily used to assess the ability to inhibit verbal responses (inhibition).	5 minutes
Secondary	Go/NoGo Test battery for attention testing (TAP)	In this test, 2 implementation forms with different stimulus material are offered. In the 1st condition, reaction times and errors are measured in a simple "Go/Nogo" condition with two stimuli (+ and x: 2 stimuli, one critical), in the 2nd more complex condition with 5 squares with different filling patterns, 2 of which are defined as critical (5 stimuli, 2 critical).	5 minutes
Secondary	Trail-Making-Test (D-KEFS)	The D-KEFS Trail Making Test is a revision and extension of the classic alternating number and letter matching task, which is known as a proven instrument for assessing cognitive flexibility. With the help of four additional conditions, the basic abilities of visual scanning, connecting numbers and letters, and motor speed can be assessed. This results in a differentiated overall picture of the interaction of different basic and higher cognitive abilities.	5 minutes
Secondary	Number-Letter-sequencing (WISC-V)	In number repeating, the subject is read a sequence of numbers and asked to repeat them in the same order (number repeating - forwards), in reverse order (number repeating - backwards) or in ascending order (number repeating - sequential).	10 minutes
Secondary	Tower Task from the (D-KEFS)	The D-KEFS Tower Test is a revision of classic tower tasks in which discs are to be restacked with the help of three rods in such a way that given tower templates are replicated, while observing certain rules. Nine standardised tasks covering a difficulty spectrum from very easy to very difficult are designed to avoid floor and ceiling effects. The test measures, among other things, spatial planning ability, rule learning, inhibition of impulsive or perseverative response behaviour, as well as the development and maintenance of mental attitudes.	15 minutes
Secondary	Balloon Analogue Risk Task (BART)	In the experiment, participants are presented with a balloon. The participant is prompted to inflate the balloon using the Right Arrow key. After successfully inflating the balloon by 1 unit, the participant receives five points. The more the participant inflates the balloon, the more points they receive. E-Prime randomly selects a number between 1 and 100 for each trial representing the total number of inflated units before the balloon bursts. If the participant inflates the balloon too much, it pops and no points are given. Participants also have the choice to press the Left Arrow to advance the trial while keeping their points. There is one practice trial and 5 critical trials.	10 minutes