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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Kleuter Extra training program
BehavioralThe intervention was described in the included arm/group explanation.
Treatment groups
141 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Kleuter Extra test battery
The primary endpoint is a single composite score on the 'Kleuter Extra' EF test battery. This composite score will be statistically derived from the individual test results of the test battery. Therefore, the minimum and maximum values cannot be provided at this point, nor whether a higher score means a better or worse outcome.
Time frame
9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.Secondary outcomes
1
EF functioning
Single test scores from the ''Kleuter Extra'' EF test battery: * subtest 'Pencil Tap'. Scores range from 0 to 100. * subtest 'Go/No go animals'. Scores range from 0 to 60. * subtest 'Statue task'. Scores range from 0 to 30. * subtest 'Search task'. Scores range from 0 to 35. * subtest 'Sustained attention'. Scores range from 0 to 30. * subtest 'Corsi blocks'. Scores range from 0 to 26. * subtest 'Dots'. Scores range from 0 to 37. * subtest 'Numbers'. Scores range from 0 to 54. * subtest 'Three is Correct'. Scores range from 0 to 78. * subtest 'Head-Shoulders-Knees-Toes'. Scores range from 0 to 52. A higher score indicates a better outcome for all subtests, except the 'Pencil Tap' task. The scores are converted into percentiles ranging from the lowest percentile rank (0-3) to the highest percentile rank (\>75) with a higher score indicating a better outcome.
Time frame
9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.2
Information processing
Cognitive Proficiency Index of the WPPSI-IV-NL. This index score is based on the test results of the following subtests: * subtest 'Picture Memory' * subtest 'Zoo Locations' * subtest 'Bug Search' * subtest 'Cancellation' * subtest 'Animal Coding'. The scale scores range from 1 to 19 and a higher score indicates a better outcome.
Time frame
9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.3
Executive functioning in daily life - completed by the parent(s)
Behavior Rating Inventory of Executive Function - Preschool Version questionnaire (BRIEF-P): t-scores range from 20-80, higher scores indicate worse outcome)
Time frame
9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.4
Behavioral and emotional difficulties of the child - completed by the parent(s)
Child Behavioral Checklist questionnaire 1,5 - 5 years old (CBCL): t-scores range from 50-100, higher scores indicate worse outcome)
Time frame
9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.Sponsors and contacts
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Source ClinicalTrials.gov