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

Fun and cognitive demand

时间窗: 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.

Children's Feeling Scale

时间窗: 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.

Acceptance and Feasibility scale

时间窗: 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.

Completion rate (Objective Feasibility):

时间窗: 5 minutes

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

Observed engagement

时间窗: 2 minutes

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

Session data

时间窗: 5 minutes

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

Recruitment rate

时间窗: 5 minutes

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

E-Fit Fidelity Measurement System tool

时间窗: 8 hours

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

Feedback in coaching sessions

时间窗: 5 minutes

qualitative feedback during the sessions about practicality of the intervention

Observed involvement

时间窗: 5 minutes

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

Session rating scale

时间窗: 2 minutes

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

Retention rate

时间窗: 2 minutes

participants who finished the study/participants who enrolled

Occurrence of adverse events (AEs)

时间窗: From Start of the study until the end of the study, assessed up to 25 months

Amount of adverse events

Behavior Rating Inventory of Executive Function (BRIEF)

时间窗: 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).

Color word Interference Task (D-KEFS)

时间窗: 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).

Go/NoGo Test battery for attention testing (TAP)

时间窗: 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).

Trail-Making-Test (D-KEFS)

时间窗: 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.

Number-Letter-sequencing (WISC-V)

时间窗: 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).

Tower Task from the (D-KEFS)

时间窗: 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.

Balloon Analogue Risk Task (BART)

时间窗: 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.