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