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

NCT06267430 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2024-11-29

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease
  • Executive Dysfunction
  • Attention Disorder

Interventions

BEHAVIORAL

Kleuter Extra training program

The intervention was described in the included arm/group explanation.

Sponsors & Collaborators

Principal Investigators

  • André Rietman · Erasmus Medical Center

  • Renske Schappin · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-11-02
Completion
2027-12-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06267430 on ClinicalTrials.gov