EF Intervention in Children With Severe Congenital Heart Disease (E-FIT)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Defects, Congenital; Executive Dysfunction
• Intervention / Treatment: Other: E-Fit

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8032
      • Children's Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention group will have a play-based intervention, including online games, analogue card games as well as a weekly coaching session to enhance executive functions.	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.
No Intervention: Control; The control group will get access to the online games, a list of the analogue card games used and fact sheets about possibilities to enhance executive functions in everyday life (which are used in the intervention group during the coachings) after finishing the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Completion rate (Objective Feasibility):	Frequency (amount of participants who completed the training)/(total amount of participants enrolled)	5 minutes
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
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
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
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
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
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
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
Children'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
Observed engagement	Engagement of the participant during coaching sessions rated on a 7-point Likert scale	2 minutes
Session data	duration, number of completed sessions, and for the computerized training, the coaching, and the card games	5 minutes
Recruitment rate	amount of participants who agreed to participate/amount of invited participants	5 minutes
E-Fit Fidelity Measurement System tool	Tool to check whether the intervention was implemented as intended, answered by "yes" and "no" for each item	8 hours
Feedback in coaching sessions	qualitative feedback during the sessions about practicality of the intervention	5 minutes
Observed involvement	involvement of the coach rated in 3 questions on a 7-point Likert scale	5 minutes
Session rating scale	4 questions about the practicality of the session rated by the participant	2 minutes
Retention rate	participants who finished the study/participants who enrolled	2 minutes
Occurrence of adverse events (AEs)	Amount of adverse events	From Start of the study until the end of the study, assessed up to 25 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Family Relationship Index	27 questions answered "does apply" or "does not apply"	10 minutes
Kidscreen-10	10 questions to assess the child's subjective health and well-being on a 5-point Likert scale	5 minutes
Kidscreen-27	27 questions to assess the child's health and well-being from a parent's perspective on a 5-point Likert scale	10-15 minutes
short form of the Conners-3	42 questions answered on a 4-point Likert scale and 2 open questions to screen for behavioral problems	20 minutes
Social Responsiveness Scale	65 questions answered on a 4-point Likert scale to screen for behavioral problems	20 minutes
Resilience Scale	13 questions answered on a 7-point Likert scale to assess resilience by acceptance of self-, life- and personal competencies	5 minutes

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): May 24, 2024
• Study Completion (Actual): August 14, 2024

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: Teen Heart Intervention

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No