Actively Recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With a Severe CHD
Led by Erasmus Medical Center · Updated on 2024-11-29
141
Participants Needed
3
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With a Severe CHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child aged 4.0 to 6.0 years, or aged 6.0 to 7.0 years and still in kindergarten
- Child had congenital heart disease surgery within the first six months of life or cyanotic CHD surgery within the first 12 months
- Child has an estimated IQ greater than 55 (no moderate to severe intellectual disability)
- Child shows diminished executive functioning (score at or below 25th percentile on KleuterExtra test battery)
- Child understands Dutch well enough to participate in tests and training
- Parent(s) understand Dutch well enough to understand study information and complete questionnaires
You will not qualify if you...
- Child is currently receiving targeted executive functioning support at school
- Child has severe brain damage with estimated IQ below 55
- Child has genetic syndromes that affect cognitive performance, such as Down syndrome
- Child has severe psychiatric disorders needing treatment first, including posttraumatic stress disorder, separation anxiety disorder, or reactive attachment disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University Medical Center - Beatrix children's hospital Groningen
Groningen, Netherlands, 9713GZ
Actively Recruiting
2
Erasmus Medical Center Sophia Children's Hospital
Rotterdam, Netherlands, 3015CN
Actively Recruiting
3
University Medical Center - Wilhelmina children's hospital Utrecht
Utrecht, Netherlands, 3584EA
Not Yet Recruiting
Research Team
E
Eveline Oppelaar
CONTACT
A
André Rietman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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