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

NCT06267430 | Recruiting

• 1 other identifier: NL85141.078.23
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 3

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 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

Keywords

Congenital heart disease; Preschooler; Executive functions; Training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• EF functioning

  9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.

• Information processing

  9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.

• Executive functioning in daily life - completed by the parent(s)

  9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.

• Behavioral and emotional difficulties of the child - completed by the parent(s)

  9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.

• Quality of the child's life - completed by the parent(s)

  9 weeks after baseline. Additional measures at 6 months and 12 months after baseline.

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Kleuter Extra training program

Control group

NO INTERVENTION

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.

Interventions

Kleuter Extra training program BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Children with severe brain damage (estimated IQ \< 55)
• Genetic syndromes known to directly affect cognitive performance (e.g. Down syndrome)

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (3)

University Medical Center - Beatrix children&#39;s hospital Groningen

Groningen, 9713GZ, Netherlands

RECRUITING

Erasmus Medical Center Sophia Children&#39;s Hospital

Rotterdam, 3015CN, Netherlands

RECRUITING

University Medical Center - Wilhelmina children's hospital Utrecht

Utrecht, 3584EA, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Cognition Disorders

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurocognitive Disorders; Mental Disorders

Study Officials

• André Rietman

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Renske Schappin

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eveline Oppelaar

CONTACT

0031107040209; e.oppelaar@erasmusmc.nl

André Rietman

CONTACT

0031107036090; a.rietman@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The psychologist testing all participants, will be blinded for the allocation of the participants.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Neuropsychologist

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: February 20, 2024
• Study Start: May 1, 2024
• Primary Completion: November 2, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)