Effectiveness of an Executive Function Training Program for Preschoolers with Severe Congenital Heart Disease
The Effectiveness of a Personalized Executive Functioning Training Program for Pre-schoolers With a Severe Congenital Heart Disease
NA · Erasmus Medical Center · NCT06267430
This study is testing a special training program to see if it can help preschoolers with severe congenital heart disease improve their thinking and self-control skills.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 141 (estimated) |
| Ages | 4 Years to 7 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center (other) |
| Locations | 3 sites (Groningen and 2 other locations) |
| Trial ID | NCT06267430 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a personalized executive function training program called 'Kleuter Extra' for children aged 4-6 years with severe congenital heart disease (CHD). The program aims to improve executive functioning skills, which are crucial for self-regulation and goal-directed behavior. The study also explores the impact of the parent-child relationship on the child's executive function development, considering the psychosocial challenges faced by families dealing with CHD. Participants will be assessed using a test battery to determine their eligibility based on executive function scores. The study is conducted at multiple medical centers in the Netherlands.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-6 years with a history of severe congenital heart disease requiring surgery in infancy and demonstrating diminished executive function.
Not a fit: Patients who do not have congenital heart disease or those with moderate to severe intellectual disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance cognitive and emotional development in preschoolers with severe CHD, leading to better long-term outcomes.
How similar studies have performed: Previous pilot studies have shown promising results for similar executive function training approaches in young children.
Eligibility criteria
Show full inclusion / exclusion 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 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 * 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 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.
Where this trial is running
Groningen and 2 other locations
- University Medical Center - Beatrix children's hospital Groningen — Groningen, Netherlands (RECRUITING)
- Erasmus Medical Center Sophia Children's Hospital — Rotterdam, Netherlands (RECRUITING)
- University Medical Center - Wilhelmina children's hospital Utrecht — Utrecht, Netherlands (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: André Rietman — Erasmus Medical Center
- Study coordinator: Eveline Oppelaar
- Email: e.oppelaar@erasmusmc.nl
- Phone: 0031107040209
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Heart Disease, Executive Dysfunction, Attention Disorder, Congenital heart disease, Preschooler, Executive functions, Training