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 (N female =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 (g A1 ) = −0.408 to −0.903) and in social responsiveness (g A1 = −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 .
Schmid et al. (Fri,) studied this question.