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

Launched by ERASMUS MEDICAL CENTER · Feb 12, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Learning by Heart," is investigating a special training program designed to help young children aged 4 to 7 years who have severe congenital heart disease (CHD) and are experiencing difficulties with their executive functioning (EF). Executive functioning refers to a set of skills that help with focus, organization, and self-control, which are essential for a child's development. The study aims to see if a personalized EF training program called 'Kleuter Extra' can effectively improve these skills in children with CHD while also considering how the parent-child relationship might affect this process.

To be eligible for the study, children must be between 4 and 6 years old (or aged 6 to 7 if still in kindergarten), have undergone heart surgery within their first year of life, and show signs of EF difficulties. Parents should also be able to understand Dutch to participate in the study. If selected, participants can expect to take part in the training program and various tests to assess their progress. The hope is that by improving EF skills, these children will have better developmental outcomes, leading to a brighter future.

Gender

ALL

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 receiving targeted EF support at school upon inclusion.
• • Children with severe brain damage (estimated IQ \< 55)
• • Genetic syndromes known to directly affect cognitive performance (e.g. Down syndrome)
• • Children with severe psychiatric disorders upon inclusion that require treatment first, such as a posttraumatic stress disorder, separation anxiety disorder, or reactive attachment disorder.