{
  "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 (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 (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.",
  "authors": [
    {
      "affiliations": [
        "Child Development Center, University Children’s Hospital Zurich, Zürich, Switzerland",
        "Children’s Research Center, University Children’s Hospital Zurich, Zürich, Switzerland"
      ],
      "name": "Alenka S Schmid"
    },
    {
      "affiliations": [
        "Child Development Center, University Children’s Hospital Zurich, Zürich, Switzerland",
        "Children’s Research Center, University Children’s Hospital Zurich, Zürich, Switzerland",
        "Department of Forensic and Neurodevelopmental Sciences, King’s College London Institute of Psychiatry Psychology & Neuroscience, London, UK"
      ],
      "name": "Melanie Ehrler"
    },
    {
      "affiliations": [
        "Department of Psychology & Helen Wills Neuroscience Institute, University of California Berkeley, Berkeley, California, USA"
      ],
      "name": "Silvia A Bunge"
    },
    {
      "affiliations": [
        "Children’s Research Center, University Children’s Hospital Zurich, Zürich, Switzerland",
        "Department of Cardiology, University Children’s Hospital Zurich, Zurich, Switzerland",
        "University of Zurich, Zürich, Switzerland"
      ],
      "name": "Oliver Kretschmar"
    },
    {
      "affiliations": [
        "Children’s Research Center, University Children’s Hospital Zurich, Zürich, Switzerland",
        "Department of Psychosomatics and Psychiatry, University Children’s Hospital Zurich, Zürich, Switzerland",
        "Division of Child and Adolescent Health Psychology, Department of Psychology, University of Zurich, Zürich, Switzerland"
      ],
      "name": "Markus A Landolt"
    },
    {
      "affiliations": [
        "Division of Biostatistics Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland"
      ],
      "name": "Valentin Rousson"
    },
    {
      "affiliations": [
        "Children’s Research Center, University Children’s Hospital Zurich, Zürich, Switzerland",
        "University of Zurich, Zürich, Switzerland",
        "MR Research Centre, University Children’s Hospital Zurich, Zürich, Switzerland"
      ],
      "name": "Ruth O’Gorman Tuura"
    },
    {
      "affiliations": [
        "Child Development Center, University Children’s Hospital Zurich, Zürich, Switzerland",
        "Children’s Research Center, University Children’s Hospital Zurich, Zürich, Switzerland",
        "University of Zurich, Zürich, Switzerland"
      ],
      "name": "Flavia M Wehrle"
    },
    {
      "affiliations": [
        "Child Development Center, University Children’s Hospital Zurich, Zürich, Switzerland",
        "Children’s Research Center, University Children’s Hospital Zurich, Zürich, Switzerland",
        "University of Zurich, Zürich, Switzerland",
        "URPP Adaptive Brain Circuits in Development and Learning, University of Zurich, Zürich, Switzerland"
      ],
      "name": "Beatrice Latal"
    }
  ],
  "title": "Multimodal personalised executive function intervention (E-Fit) for school-aged children with complex congenital heart disease in Switzerland: a randomised controlled feasibility study",
  "uid": "c62b27cd-efa1-544c-803e-60de23dd2bee"
}