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

Clinical Snapshot

Key Findings

• P Value: Not reported in abstract

• Effect Size: Moderate effect sizes favouring intervention group: Hedge's g = -0.408 to -0.903 for Behavioral Regulation Index

• Primary Outcome: Feasibility demonstrated across all domains: acceptable intervention, 90% retention rate, good implementation fidelity, and successful integration into home settings

• Nnt Or Sensitivity: Not applicable for feasibility study; effect sizes suggest potential clinical benefit

• Confidence Interval: Not reported in abstract

Clinical Application

Intervention appears feasible in clinical practice with remote delivery components, though computerised training adherence may need improvement strategies Relevant to Australian paediatric cardiology and developmental services; remote delivery model suits Australian geography; intervention components align with NDIS support frameworks for children with developmental needs Children aged 10-12 years with complex congenital heart disease experiencing executive function difficulties, particularly those with BRIEF T-scores ≥60

Abstract

OBJECTIVE: To explore the feasibility of a novel multimodal executive function intervention in school-aged children with complex congenital heart disease (cCHD). DESIGN: Single-centre, single-blinded, randomised-controlled 8-week multimodal personalised executive function intervention (E-Fit) study. Outcomes were measured throughout the intervention, post-intervention (T1) and at 4-month follow-up (T2). SETTING: Tertiary care centre between May 2022 and May 2024. PARTICIPANTS: Children 10 to 12 years (M=11.0, SD=0.9) with cCHD without a genetic diagnosis with infant open-heart surgery and reported difficulties (T-scores ≥60) on any of the summary scales of the parent- or teacher-reported Behavior Rating Inventory for Executive Function (BRIEF). INTERVENTIONS: Children with cCHD were randomly assigned to one of two groups: the intervention or the control group. The 8-week intervention was multimodal including three modalities: (1) computerised executive function (EF) training 3×20 min/week with CogniFit; (2) a weekly, remote standardised 1:1 individual EF strategy coaching; (3) analogue games played at convenience. The control group completed activity logs. FEASIBILITY MEASURES: Acceptability: Acceptance and Feasibility Scale (AFS) and coach-rated engagement during coaching sessions. Demand: Number of completed computerised training, strategy coaching and analogue game sessions. IMPLEMENTATION: E-Fit Fidelity Measurement System, assessing adherence to core components. Practicality: Retention rate. Integration: AFS integration items. Exploratory efficacy: BRIEF, neuropsychological EF testing and psychosocial variables at baseline, post-intervention (8 weeks) and at 4-month follow-up. RESULTS: We recruited 42 participants (Nfemale=20). Acceptability: The intervention was acceptable, with moderate observed engagement. Demand: median number of computerised training sessions completed was 16 of 24 sessions (67%, (IQR; 6 to 19)), all children attended all scheduled coaching sessions, analogue games were played in total a median of 9 times (IQR 4 to 14). IMPLEMENTATION: Coaching sessions could be implemented by the coaches as intended. Practicality: Overall retention rate was 90%. Integration: E-Fit was well integrable into the home setting. Exploratory efficacy favoured the intervention group with improvements in the parent-rated Behavioral Regulation Index of the BRIEF (adjusted Hedge's (gA1) = -0.408 to -0.903) and in social responsiveness (gA1 = -0.427 to -0.521) at T1 and at T2. CONCLUSIONS: E-Fit is a feasible intervention suggesting EF and social responsiveness improvements in children with cCHD. Motivational strategies to improve adherence to computerised training should be refined before a full-scale efficacy trial. TRIAL REGISTRATION NUMBER: NCT05198583.

References

1. 1.Schmid, A. S., Ehrler, M., Bunge, S. A., Kretschmar, O., Landolt, M. A., Rousson, V., Tuura, R. O., Wehrle, F. M., & Latal, B. (2026). Multimodal personalised executive function intervention (E-Fit) for school-aged children with complex congenital heart disease in Switzerland: a randomised controlled feasibility study. BMJ Open, 16(5), e107681. https://doi.org/10.1136/bmjopen-2025-107681