Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06267430
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-12-12
Brief Title:
Learning by Heart The Effectiveness of an EF Training Program for Pre-schoolers With a Severe CHD
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
The Effectiveness of a Personalized Executive Functioning Training Program for Pre-schoolers With a Severe Congenital Heart Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LbH
Brief Summary:
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 childs 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 parents andor caretakers may impact EF-development If found effective EF training for children with severe CHD will improve their developmental outcome
Detailed Description:
Advances in prenatal and neonatal care have improved outcome in children with severe congenital heart disease CHD 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 behaviour 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 childs EF development Looking at the reciprocal nature of relationships the childs illness andor 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 childs 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 severe 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 Cohens d effect sizes ranging from 019 to 241 100 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 severe CHD 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 severe CHD will improve their developmental outcome
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 childs 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 severe 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 Cohens d effect sizes ranging from 019 to 241 100 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 severe CHD 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 severe CHD will improve their developmental outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None