nctId: NCT06267430 id: NL85141.078.23 briefTitle: Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With a Severe CHD acronym: LbH overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-12-31 date: 2027-04-30 date: 2024-02-20 date: 2024-02-20 name: Erasmus Medical Center class: OTHER briefSummary: 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: Congenital Heart Disease conditions: Executive Dysfunction conditions: Attention Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The psychologist testing all participants, will be blinded for the allocation of the participants. whoMasked: INVESTIGATOR count: 141 type: ESTIMATED name: Kleuter Extra training program measure: Kleuter Extra test battery measure: EF functioning measure: Information processing measure: Executive functioning in daily life - completed by the parent(s) measure: Behavioral and emotional difficulties of the child - completed by the parent(s) measure: Quality of the child's life - completed by the parent(s) measure: Emotional distress parent - completed by the parent(s) measure: Parental trauma measure: Parenting behavior and quality parent-child relationship - completed by the parent(s) measure: Child demographics teacher's perspective measure: Behavioral and emotional difficulties teacher's perspective measure: Executive functioning child in daily life teacher's perspective sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: University Medical Center - Beatrix children's hospital Groningen city: Groningen zip: 9713GZ country: Netherlands name: Hessel Nijenhuis role: CONTACT email: h.p.nijenhuis@umcg.nl lat: 53.21917 lon: 6.56667 facility: Erasmus Medical Center Sophia Children's Hospital city: Rotterdam zip: 3015CN country: Netherlands name: André Rietman role: CONTACT email: a.rietman@erasmusmc.nl lat: 51.9225 lon: 4.47917 facility: University Medical Center - Wilhelmina children's hospital Utrecht city: Utrecht zip: 3584EA country: Netherlands name: Hans Breur role: CONTACT phone: +31 88 75 754 59 email: h.breur@umcutrecht.nl lat: 52.09083 lon: 5.12222 hasResults: False