The effectiveness of a personalized executive functioning training program for pre-schoolers with a severe congenital heart disease.

Recruiting

• Conditions: Congenital Heart Disease; 10007510; 10009841

• Registration Number: NL-OMON56699
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 144

Inclusion 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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is a single composite score on the *Kleuter Extra* EF test<br /><br>battery, at 9 weeks after baseline. </p><br>