Skip to main content
OpenTrials
Completed

NCT Number: NCT05198583

EF Intervention in Children With Severe Congenital Heart Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Zurich

Zurich, Canton of Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E-Fit

Other

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.

Primary outcomes

  1. Fun and cognitive demand

    Time frame: 5 minutes

    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.

  2. Children's Feeling Scale

    Time frame: 5 minutes

    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.

  3. Acceptance and Feasibility scale

    Time frame: 5 minutes

    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.

  4. Completion rate (Objective Feasibility):

    Time frame: 5 minutes

    Frequency (amount of participants who completed the training)/(total amount of participants enrolled)

  5. Observed engagement

    Time frame: 2 minutes

    Engagement of the participant during coaching sessions rated on a 7-point Likert scale

  6. Session data

    Time frame: 5 minutes

    duration, number of completed sessions, and for the computerized training, the coaching, and the card games

  7. Recruitment rate

    Time frame: 5 minutes

    amount of participants who agreed to participate/amount of invited participants

  8. E-Fit Fidelity Measurement System tool

    Time frame: 8 hours

    Tool to check whether the intervention was implemented as intended, answered by "yes" and "no" for each item

  9. Feedback in coaching sessions

    Time frame: 5 minutes

    qualitative feedback during the sessions about practicality of the intervention

  10. Observed involvement

    Time frame: 5 minutes

    involvement of the coach rated in 3 questions on a 7-point Likert scale

  11. Session rating scale

    Time frame: 2 minutes

    4 questions about the practicality of the session rated by the participant

  12. Retention rate

    Time frame: 2 minutes

    participants who finished the study/participants who enrolled

  13. Occurrence of adverse events (AEs)

    Time frame: From Start of the study until the end of the study, assessed up to 25 months

    Amount of adverse events

  14. Behavior Rating Inventory of Executive Function (BRIEF)

    Time frame: 15 minutes

    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. Color word Interference Task (D-KEFS)

    Time frame: 5 minutes

    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).

  16. Go/NoGo Test battery for attention testing (TAP)

    Time frame: 5 minutes

    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).

  17. Trail-Making-Test (D-KEFS)

    Time frame: 5 minutes

    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.

  18. Number-Letter-sequencing (WISC-V)

    Time frame: 10 minutes

    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).

  19. Tower Task from the (D-KEFS)

    Time frame: 15 minutes

    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.

  20. Balloon Analogue Risk Task (BART)

    Time frame: 10 minutes

    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.

Secondary outcomes

  1. The Family Relationship Index

    Time frame: 10 minutes

    27 questions answered "does apply" or "does not apply"

  2. Kidscreen-10

    Time frame: 5 minutes

    10 questions to assess the child's subjective health and well-being on a 5-point Likert scale

  3. Kidscreen-27

    Time frame: 10-15 minutes

    27 questions to assess the child's health and well-being from a parent's perspective on a 5-point Likert scale

  4. short form of the Conners-3

    Time frame: 20 minutes

    42 questions answered on a 4-point Likert scale and 2 open questions to screen for behavioral problems

  5. Social Responsiveness Scale

    Time frame: 20 minutes

    65 questions answered on a 4-point Likert scale to screen for behavioral problems

  6. Resilience Scale

    Time frame: 5 minutes

    13 questions answered on a 7-point Likert scale to assess resilience by acceptance of self-, life- and personal competencies

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

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

Acronym: E-FIT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2022
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.