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Updated: Jul 11, 2025
Multimodal Protocol for Assessing Metacognition and Self-Regulation in Adults with Learning Difficulties
Published on: September 27, 2020
Multimodal personalised executive function intervention (E-Fit) for school-aged children with complex congenital
Alenka Sarah Schmid1, Melanie Ehrler1,2,3, Flavia Wehrle1,2,4
1Child Development Center, University Children's Hospital Zurich, Zurich, Switzerland.
Insights
This study tests the feasibility of E-Fit, a new personalized intervention for children with complex congenital heart disease (CHD) and executive function (EF) challenges. Results will guide future trials on improving EF in this vulnerable population.
Area of Science:
- Pediatric Cardiology
- Neurodevelopmental Disorders
- Rehabilitation Medicine
Background:
- Children with congenital heart disease (CHD) often experience executive function (EF) impairments.
- Current interventions for EF deficits in complex CHD have shown limited effectiveness.
- A novel, personalized, multimodal intervention (E-Fit) has been developed to address these challenges.
Purpose of the Study:
- To assess the feasibility of the E-Fit intervention for children with complex CHD and EF impairments.
- To gather data on recruitment, adherence, and participant/provider experiences.
- To inform the design of a future randomized controlled trial (RCT) investigating E-Fit's effectiveness.
Main Methods:
- A single-center, single-blinded, randomized controlled feasibility study.
- Enrolled 40 children (10-12 years) with CHD and significant EF impairments.
- Intervention group received personalized computer-based training, remote coaching, and games; control group followed usual routines.
Main Results:
- Feasibility will be measured by adherence, recruitment rates, and participant/provider feedback.
- The study is designed to evaluate the potential of E-Fit to improve EF in children with CHD.
- Data collected will determine the viability of a larger RCT.
Conclusions:
- The E-Fit intervention shows promise as a feasible approach for improving executive functions in children with complex CHD.
- Feasibility findings will guide the development of a full-scale RCT.
- This research addresses a critical need for effective EF interventions in pediatric CHD.
Introduction:
Children with congenital heart disease (CHD) are at risk for executive functions (EF) impairments. To date, interventions have limited effects on EF in children and adolescents with complex CHD. Therefore, we developed a new multimodal and personalised EF intervention (E-Fit). This study aims to test the feasibility of this intervention called 'E-Fit' for children with complex CHD and EF impairments.
Methods And Analysis:
This is a single-centre, single-blinded, randomised controlled feasibility study exploring the E-Fit intervention. We aim to enrol 40 children with CHD aged 10-12 years who underwent infant cardiopulmonary bypass surgery and show clinically relevant EF impairments (T-score ≥60 on any Behaviour Rating Inventory for Executive Function questionnaire summary scale). The multimodal intervention was developed with focus groups and the Delphi method involving children and adolescents with CHD, their parents and teachers, and health professionals. The intervention is composed of three elements: computer-based EF training using CogniFit Inc 2022, performed three times a week at home; weekly EF remote strategy coaching and analogue games. The content of the computer and strategy training is personalised to the child's EF difficulties. The control group follows their daily routines as before and completes a diary about their everyday activities four times a week. Participants will be randomised in a 1:1 ratio. Feasibility is measured by the participants' and providers' ratings of the participants' adherence and exposure to the intervention, recruitment rates and the evaluation of the intended effects of the programme.
Ethics And Dissemination:
Local ethics committee approval was obtained for the study (BASEC-Nr: 2021-02413). Parents provide written informed consent. Key outputs from the trial will be disseminated through presentations at conferences, peer-reviewed publications and directly to participating families. Furthermore, these results will inform the decision whether to proceed to a randomised controlled trial to investigate effectiveness.
Trial Registration Number:
NCT05198583.
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