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Recruiting NCT06267430

Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With a Severe CHD

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Plain-language summary for patients

Trial Parameters

Condition Congenital Heart Disease
Sponsor Erasmus Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 141
Sex ALL
Min Age 4 Years
Max Age 7 Years
Start Date 2024-05-01
Completion 2025-11-02
Interventions
Kleuter Extra training program

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Brief Summary

Advances in prenatal and neonatal care have improved outcomes in children with severe congenital heart disease (CHD). With the increase in survival, neurocognitive problems such as executive functioning (EF) impairments have become more apparent in these children. EF problems have cascading negative effects on a child's development. New insights in EF development suggest that in otherwise physically healthy young children, EF can be improved by training. In a pilot study funded by Stichting Hartekind, the investigators studied the feasibility of a personalized EF training program called 'Kleuter Extra' and the results were promising. Therefore, the current study will investigate the effectiveness of this program in 4-6-year-old children with severe CHD. The researchers will also explore interactions between the parent-child relationship and EF development of the child as psychosocial difficulties in these children and their parent(s) and/or caretaker(s) may impact EF-development. If found effective, EF training for children with severe CHD will improve their developmental outcome.

Eligibility Criteria

In order to be eligible to participate in this study, a child must meet all of the following criteria: * Aged 4.0 - 6.0 years upon inclusion OR aged 6.0-7.0 years who are still in kindergarten (group 1 \& 2 of the Dutch school system) * Required CHD surgery in the first six months of life (with or without ECMO) or a cyanotic CHD that required surgery in the first 12 months of life * IQ estimated \> 55 (no moderate to severe intellectual disability) * Diminished EF based on a below average score on any of the subtests of the 'KleuterExtra' test battery (≤ 25 percentile) at t = 0 * Sufficient comprehension of the Dutch language by the child to be able to participate in the EF test battery and the EF training program. In order to be eligible to participate in this study, the parent(s) must meet the following criteria: * Sufficient comprehension of the Dutch language to understand the study information and to be able to fill out the Dutch questionnaires. Exclusion Criteria: * Children rece

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