Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With a Severe CHD

Congenital Heart Disease Clinical Trial

— LbH  

Official title:

The Effectiveness of a Personalized Executive Functioning Training Program for Pre-schoolers With a Severe Congenital Heart Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06267430
• Other study ID #: NL85141.078.23
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: February 2024
• Source: Erasmus Medical Center
• Contact: Eveline Oppelaar
• Phone: +31107040209
• Email: e.oppelaar[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 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 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 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 141
• Est. completion date: April 30, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria:

• Children aged 4.0 - 6.0 years upon inclusion with severe CHD according to the criteria of Marino (Marino, 2012)
• 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
• Sufficient comprehension of the Dutch language by parents to understand the study information and to be able to fill out the Dutch questionnaires.
• Sufficient comprehension of the Dutch language by the child to be able to participate in the EF test battery and the EF training program.

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.

Related Conditions & MeSH terms

• Attention Disorder
• Cognition Disorders
• Congenital Heart Disease
• Executive Dysfunction
• Heart Defects, Congenital
• Heart Diseases

Intervention

Behavioral:
• Kleuter Extra training program
The intervention was described in the included arm/group explanation.

Locations

Country	Name	City	State
Netherlands	University Medical Center - Beatrix children's hospital Groningen	Groningen
Netherlands	Erasmus Medical Center Sophia Children's Hospital	Rotterdam
Netherlands	University Medical Center - Wilhelmina children's hospital Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
Secondary	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.	9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
Secondary	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.	9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
Secondary	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)	9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
Secondary	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)	9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
Secondary	Quality of the child's life - completed by the parent(s)	Preschool Children Quality of Life questionnaire (TAPQOL): t-scores range from 0 - 100, higher score indicates better outcome.	9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
Secondary	Emotional distress parent - completed by the parent(s)	Depression, Anxiety, Stress Scale (DASS-21): scores range from 0-63, higher score indicates worse outcome)	9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
Secondary	Parental trauma	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.
Secondary	Parenting behavior and quality parent-child relationship - completed by the parent(s)	Parenting Behavior questionnaire (PABI): scores range from 0-525, a higher score can mean a better or worse outcome depending on the specific scale.	9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
Secondary	Child demographics teacher's perspective	Additional support in school, type, being held back a year (qualitative data, designed by the study group)	9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
Secondary	Behavioral and emotional difficulties teacher's perspective	Teacher's Report Form questionnaire (TRF): t-scores range from 50-100, higher scores indicate worse outcome)	9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.
Secondary	Executive functioning child in daily life teacher's perspective	Behavior Rating Inventory of Executive Function questionnaire - teachers (BRIEF); 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.