Multimodal personalised executive function intervention (E-Fit) for school-aged children with complex congenital heart disease: protocol for a randomised controlled feasibility study.

Autor:	Schmid AS; Child Development Center, University Children's Hospital Zurich, Zurich, Switzerland., Ehrler M; Child Development Center, University Children's Hospital Zurich, Zurich, Switzerland.; Children's Research Center, University Children's Hospital Zurich, Zurich, Switzerland.; URPP Adaptive Brain Circuits in Development and Learning, University of Zurich, Zurich, Switzerland., Wehrle F; Child Development Center, University Children's Hospital Zurich, Zurich, Switzerland.; Children's Research Center, University Children's Hospital Zurich, Zurich, Switzerland.; Department of Neonatology and Intensive Care, University Children's Hospital Zurich, Zurich, Switzerland., Tuura RO; Child Development Center, University Children's Hospital Zurich, Zurich, Switzerland.; Children's Research Center, University Children's Hospital Zurich, Zurich, Switzerland.; University of Zurich, Zurich, Switzerland.; MR Research Centre, University Children's Hospital Zurich, Zurich, Switzerland., Kretschmar O; Children's Research Center, University Children's Hospital Zurich, Zurich, Switzerland.; University of Zurich, Zurich, Switzerland.; Department of Cardiology, University Children's Hospital Zurich, Zurich, Switzerland., Landolt M; Children's Research Center, University Children's Hospital Zurich, Zurich, Switzerland.; Department of Psychosomatics and Psychiatry, University Children's Hospital Zurich, Zurich, Switzerland.; Division of Child and Adolescent Health Psychology, Department of Psychology, University of Zurich, Zurich, Switzerland., Latal B; Child Development Center, University Children's Hospital Zurich, Zurich, Switzerland bea.latal@kispi.uzh.ch.; Children's Research Center, University Children's Hospital Zurich, Zurich, Switzerland.; URPP Adaptive Brain Circuits in Development and Learning, University of Zurich, Zurich, Switzerland.; University of Zurich, Zurich, Switzerland.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2023 Nov 09; Vol. 13 (11), pp. e073345. Date of Electronic Publication: 2023 Nov 09.
DOI:	10.1136/bmjopen-2023-073345
Abstrakt:	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. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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