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

Sponsor
Erasmus Medical Center
Study ID
NCT06267430
Status
Recruiting
Apply to this trial

Conditions

  • Attention Disorder
  • Congenital Heart Disease
  • Executive Dysfunction

Eligibility Criteria

Sex
ALL
Age
4 Years - 7 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Feb 20, 2024
Start date
May 1, 2024
Status verified
Nov 2024
Primary completion
Nov 2, 2025
Completion
Dec 31, 2027

Study Design

Enrollment
141 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

Kleuter Extra test battery [ Time Frame: 9 weeks after baseline. Additional measures at 6 months and 12 months after baseline. ]

Central Contacts

Related Studies