The Effectiveness of a Personalized Executive Functioning Training Program for Pre-schoolers With a Severe Congenital Heart Disease

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 7
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Netherlands
University Medical Center - Beatrix children's hospital Groningen
RECRUITING
Groningen
Erasmus Medical Center Sophia Children's Hospital
RECRUITING
Rotterdam
University Medical Center - Wilhelmina children's hospital Utrecht
NOT_YET_RECRUITING
Utrecht
Contact Information
Primary
Eveline Oppelaar
e.oppelaar@erasmusmc.nl
0031107040209
Backup
André Rietman
a.rietman@erasmusmc.nl
0031107036090
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 141
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov