Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD (LbH)
The Effectiveness of a Personalized Executive Functioning Training Program for Pre-schoolers With a Critical Congenital Heart Disease
Advances in prenatal and neonatal care have improved outcomes in children with critical congenital heart disease (CCHD). 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 CCHD. 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 CCHD will improve their developmental outcome.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Advances in prenatal and neonatal care have improved outcome in children with critical congenital heart disease (CCHD), with survival rates up to 90%. With the increase in survival, neurocognitive problems and psychological maladjustment have become more apparent in these children, such as impairments in their executive functioning. Executive functioning (EF) is an umbrella-term for several higher-order cognitive processes crucial for self-regulated and goal directed behavior. Frequently postulated components of EF are inhibition, including motor inhibition, and attention, working memory, and cognitive flexibility. Early EF problems often result in emotion regulation difficulties, behavioural problems, social problems, and learning problems, which can lead to diminished functioning in social domains and lower achievement levels in education and employment status. Children with CHD might be rendered even more vulnerable for EF-problems since EF development is embedded within the social context of a child. There is an increasing understanding of how naturally distressing the CHD diagnosis and treatment can be for parents, which can impair the interactions with their child and in turn might negatively impact the child's EF development. Looking at the reciprocal nature of relationships, the child's illness and/or emotional and behavioural problems that may be associated with EF difficulties might negatively impact the parent-child relationship, parenting behaviour and parental wellbeing. However, these relations are poorly understood, especially regarding fathers. A greater understanding of the interplay between biological and psychosocial factors on EF-development is needed to promote optimal developmental outcomes for these vulnerable children.
New insights suggest that EF can be improved by training. Due to neural plasticity, the window for effective training seems to be between the ages of two and six years. After this time frame, improvements in EF may not retain after training or not generalize to off-task functions. Current EF training programs are not personalised ('adaptive') but offer the same program regardless of the specific child's EF dysfunctions, which may explain their limited effects. There is presently no effective EF training program for children with CHD.
In a pilot study funded by Stichting Hartekind, the researchers investigated the feasibility of a personalised EF training program called 'KleuterExtra' in 4-6 year old children with critical CHD. Within a week, 31 children were (self-) referred for the study, indicating a great clinical need. Directly after training, children showed clinically relevant improvement on the specific EFs targeted in training, with Cohen's d effect sizes ranging from 0.19 to 2.41 (>1.00 on 5 out of 9 tasks). Improvement was also found in untrained EFs and tasks that combined multiple EFs, indicating a generalization effect. Parents and teachers spontaneously reported positive results in daily life. Based on these promising results, the investigators designed the current randomized, controlled study to test the effectiveness of this training program in pre-schoolers with severe CHD.
Given the above, the investigators designed this study to investigate the effectiveness of a tailored EF training program for preschoolers with CCHD. Secondary aim was to explore interactions between the parent-child relationship and the EF development of the child. If found effective, EF training for children with CCHD will improve their developmental outcome.
Typ studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Provincie Groningen
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Groningen, Provincie Groningen, Holandia, 9713GZ
- University Medical Center - Beatrix children's hospital Groningen
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Rotterdam
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Rotterdam, Rotterdam, Holandia, 3015CN
- Erasmus Medical Center Sophia Children's Hospital
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Utrecht
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Utrecht, Utrecht, Holandia, 3584EA
- University Medical Center - Wilhelmina children's hospital Utrecht
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
In order to be eligible to participate in this study, a child must meet all of the following criteria:
- Aged 4.0 - 5.11 years upon inclusion OR aged 6.0-6.11 years and still attending kindergarten (group 1-2 of the Dutch school system)
- Required CHD surgery in the first six months of life (with or without cardiopulmonary bypass or 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 (≤ 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:
- 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: Intervention group
The participants allocated to the intervention group will receive the personalised training program 'KleuterExtra', developed by dr. Lex Wijnroks from Utrecht University. All parents will receive the book 'Speels Brein' ('Playful Brain') and an age-appropriate addition for preschoolers to this book. |
The intervention was described in the included arm/group explanation. |
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Brak interwencji: Control group
As described, the parents of the control group will also receive the book 'Speels Brein' ('Playful Brain') and the age-appropriate addition for preschoolers to this book. |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Kleuter Extra test battery
Ramy czasowe: 9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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The primary endpoint is a single composite score on the 'KleuterExtra' EF test battery, calculated as the mean z-score (mean = 0, SD = 1) of the ten tasks of the test battery. The composite score has no fixed minimum or maximum, and a higher score indicates a better outcome. |
9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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EF functioning
Ramy czasowe: 9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Scores on the 10 individual tasks of the 'KleuterExtra' test battery, four EF domain scores (inhibition, attention, working memory, cognitive flexibility), and an integrated EF score (based on task 'Head-Toes-Knees-Shoulders'; HTKS). Raw task scores:
A higher score indicates a better outcome for all tasks, except 'Go/No go animals' (reverse scored). Raw scores are converted to z-scores (mean = 0, SD =1) for analysis. A higher z-score indicates a better outcome. Domain scores are calculated as the mean z-score of the tasks within each domain. |
9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Information processing
Ramy czasowe: 9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Cognitive Proficiency Index of the WPPSI-IV-NL: index score (mean = 100, SD =15, range 40-160), and a higher score indicates a better outcome. The CPI is based on four subtests (scaled scores 1-19):
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9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Executive functioning in daily life - completed by the parent(s)
Ramy czasowe: 9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Behavior Rating Inventory of Executive Function - Preschool Version questionnaire (BRIEF-P): t-scores range from 20-80, higher scores indicate worse outcome. The three calculated main indexes (inhibitory self-control, flexibility, and metacognition) will be used for the current trial. |
9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Behavioral and emotional difficulties of the child - completed by the parent(s)
Ramy czasowe: 9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Child Behavioral Checklist questionnaire 1,5 - 5 years old (CBCL): t-scores range from 50-100, higher scores indicate worse outcome. The three overall domains (internalizing behavior, externalizing behavior, and the total sum of problems) will be used for the current trial. |
9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Quality of the child's life - completed by the parent(s)
Ramy czasowe: 9 weeks after baseline, additional measures at 6 months and 12 months after baseline.
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Preschool Children Quality of Life questionnaire (TAPQOL): scale scores range from 0 - 100, higher score indicates better outcome. All twelve scales will be used for the current trial: stomach problems, skin problems, lung problems, sleeping problems, appetite, problem behavior, positive mood, anxiety, liveliness, social functioning, motor functioning, and communication. |
9 weeks after baseline, additional measures at 6 months and 12 months after baseline.
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Emotional distress parent - completed by the parent(s)
Ramy czasowe: 9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Depression, Anxiety, Stress Scale (DASS-21): subscale scores (depression, anxiety, stress) range from 0-21 and the total score ranges from 0-63. A higher score indicates worse outcome. These four scales will be used for this trial. |
9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Parental trauma
Ramy czasowe: 9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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PCL-5 questionnaire ('PCL-5' is the title, scores range from 0-80, higher score indicates worse outcome) |
9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Parenting behavior questionnaire - completed by the parent(s)
Ramy czasowe: 9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Parenting Behavior questionnaire (PABI; Dutch title 'Vragenlijst over opvoedgedrag'): T-scores range from 20-80. The three adaptive domains (warmth, structure, and autonomy), and three maladaptive domains (hostility, coercion, and excessive protection) will be used for the current trial. Higher scores indicate a better outcome on the adaptive domains, and a worse outcome on the maladaptive domains. |
9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Child demographics: schooling - completed by the parents
Ramy czasowe: Baseline. Changes are recorded at 9 weeks, 6 months, and 12 months after baseline.
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Additional support in school, type, being held back a year (qualitative data, designed by the study group) |
Baseline. Changes are recorded at 9 weeks, 6 months, and 12 months after baseline.
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Behavioral and emotional difficulties teacher's perspective
Ramy czasowe: 9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Teacher's Report Form questionnaire (C-TRF): t-scores range from 50-100, higher scores indicate worse outcome. The three overall domains (internalizing behavior, externalizing behavior, and the total sum of problems) will be used for the current trial. |
9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Executive functioning child in daily life teacher's perspective
Ramy czasowe: 9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Behavior Rating Inventory of Executive Function questionnaire - teachers (BRIEF-P); t-scores range from 20-80, higher scores indicate worse outcome. |
9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
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Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: André Rietman, Erasmus Medical Center
- Główny śledczy: Renske Schappin, Erasmus Medical Center
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- NL85141.078.23
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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