Personalized E-Fit program to help executive skills in kids with complex congenital heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests a personalized E-Fit program designed for children with complex congenital heart disease (cCHD) to improve everyday executive functions such as attention, planning, and self-control. The program combines digital cognitive training with individualized online coaching and analog games. Participants are 9 to 13 years old and may include those with certain genetic or syndromal conditions if IQ testing and self-reports can be completed. The study uses a randomized design to assess whether E-Fit leads to meaningful improvements in real-life executive function and daily functioning. The research is led by Bea Latal at University Children's Hospital Zurich.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Children with CHD: Born with CHD; Underwent cardiopulmonary bypass surgery before the age of one; Children with a genetic disorder or syndromal disorder will be included, if standardized IQ testing with WISC-V can be conducted, and self-rated questionnaires can be filled in; Aged 9 years 0 months to 13 years 11 months (at time of recruitment); Oral informed consent by potential participants (all ages) and parents, as well as written informed consent of parents; EF deficits showing in screening (BRIEF-score ≥ 60)
* Healthy Controls: Aged 9 years 0 months to 13 years 11 months (at time of recruitment); Oral informed consent by potential participants (all ages) and parents, as well as written informed consent of parents

Exclusion Criteria:

* Children with CHD: Heart surgery without cardiopulmonary bypass; Children with known large cerebral lesions or injuries, including stroke and severe hypoxic-ischemic encephalopathy with significant neurological sequelae; Insufficient German language skills of the child and parent(s); Attending a separative special educational school (Separative Sonderschulung)
* Healthy Controls: preterm birth (\<36 weeks of gestation); diagnosed with a neurological or substantial developmental disorder (e.g., learning disorder, attention deficit hyperactivity disorder or autism spectrum disorder); Insufficient German language skills of the child and parent(s); Attending a separative special educational school (Separative Sonderschulung)

Where it's running

• University Children's Hosptial Zurich
  Zurich, Canton of Zurich, Switzerland Recruiting

Study contacts

• Study coordinator: Prof. Dr. med. Bea Latal
• Email: bea.latal@kispi.uzh.ch
• Phone: +41 44 249 63 95

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.