Congenital Heart Disease
Conditions
Interventions
The investigated intervention is the personalised training program
*KleuterExtra*, developed by dr. Lex Wijnroks from Utrecht University.
*KleuterExtra* consists of an EF test battery and an EF-trai
Sponsors
Stichting Hartekind
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion 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 lifeIQ 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 (= 21 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a single composite score on the *Kleuter Extra* EF test battery, at 9 weeks after baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tests (child): - EF functioning: single test scores from the **Kleuter Extra** EF test battery - Information processing: Cognitive Proficiency Index of the WPPSI-IV-NL Questionnaires (both parents): - Executive functioning of the child in daily life: BRIEF-P - Behavioral and emotional difficulties of the child: CBCL (1.5- 5 years old) - Quality of the child*s life: TAPQL - Emotional distress of the parent: DASS-21 - Parental trauma: PCL-5 - Parenting behavior and quality parent-child relationship: PABI - Subjective evaluation questionnaires regarding the book *Speels Brein* (*Playful brain*) and if applicable, the training program. Questionnaires (teacher): - Child demographics: additional support in school, type, being held back a year - Behavioral and emotional difficulties of the child: TRF - Executive functioning of the child in daily life: BRIEF-teacher All primary and secondary parameters, except the subjective evaluation questionnaires, will be assessed at baseline, 9 weeks, and 6 and 12-months follow-up measures. The subjective evaluation questionnaire regarding the book *Speels Brein* (*Playful Brain*) will be administered at the three follow-up measures. The subjective evaluation questionnaire regarding the training program will be administered once, at the 9 weeks follow-up measure. Please refer to 8.3.2. *Study assessments* in the study protocol for a more detailed description. | — |
Countries
Netherlands
Contacts
Public ContactR. Schappin
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed