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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-7
SponsorErasmus Medical Center

About this trial

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

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Kleuter Extra training program

Treatment groups

141 Participants
are divided into 2 treatment groups

Sponsors and collaborators