Clinical trial NCT05198583: EF Intervention in Children With Severe Congenital Heart Disease
Official title: Executive Function and Brain Development in Adolescents With Severe Congenital Heart Disease (Teen Heart Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Defects, Congenital
Executive Dysfunction
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 42
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fun and cognitive demand
timeFrame: 5 minutes
measure: Children's Feeling Scale
timeFrame: 5 minutes
measure: Acceptance and Feasibility scale
timeFrame: 5 minutes
measure: Completion rate (Objective Feasibility):
timeFrame: 5 minutes
measure: Observed engagement
timeFrame: 2 minutes
measure: Session data
timeFrame: 5 minutes
measure: Recruitment rate
timeFrame: 5 minutes
measure: E-Fit Fidelity Measurement System tool
timeFrame: 8 hours
measure: Feedback in coaching sessions
timeFrame: 5 minutes
measure: Observed involvement
timeFrame: 5 minutes
measure: Session rating scale
timeFrame: 2 minutes
measure: Retention rate
timeFrame: 2 minutes
measure: Occurrence of adverse events (AEs)
timeFrame: From Start of the study until the end of the study, assessed up to 25 months
measure: Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: 15 minutes
measure: Color word Interference Task (D-KEFS)
timeFrame: 5 minutes
measure: Go/NoGo Test battery for attention testing (TAP)
timeFrame: 5 minutes
measure: Trail-Making-Test (D-KEFS)
timeFrame: 5 minutes
measure: Number-Letter-sequencing (WISC-V)
timeFrame: 10 minutes
measure: Tower Task from the (D-KEFS)
timeFrame: 15 minutes
measure: Balloon Analogue Risk Task (BART)
timeFrame: 10 minutes
Secondary outcomes:
measure: The Family Relationship Index
timeFrame: 10 minutes
measure: Kidscreen-10
timeFrame: 5 minutes
measure: Kidscreen-27
timeFrame: 10-15 minutes
measure: short form of the Conners-3
timeFrame: 20 minutes
measure: Social Responsiveness Scale
timeFrame: 20 minutes
measure: Resilience Scale
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Children's Hospital Zurich
state: Zurich
Study officials:
References: