Multimodal Personalised Executive Function Intervention for School-Aged Children With Complex CH

Study design and purpose: a feasibility assessment of a multimodal EF intervention for school-aged children with complex congenital heart disease

• The study is a single-centre, single-blinded, randomized controlled feasibility trial conducted to evaluate a novel multimodal executive function intervention, termed E-Fit, in children aged 10 to 12 years with complex congenital heart disease (cCHD) who lack a genetic diagnosis and show parent- or teacher-reported executive function concerns.
• The intervention duration was eight weeks, with outcomes measured repeatedly during the program, at its conclusion, and at a 4-month follow-up.

Executive function deficits are highlighted as a long-term neurodevelopmental concern in this population.

• Participants were children aged 10–12 years (mean age 11.0, SD 0.9) who had undergone infant open-heart surgery for cCHD and displayed executive function difficulties as indicated by BRIEF T-scores of 60 or higher on any domain reported by parents or teachers.
• For context, the study notes that CHD is the most common birth defect, with a subset presenting as complex forms requiring early surgery.

• E-Fit comprises three modalities designed to operate in concert:
• Computerized training targeting executive function, delivered three times weekly for 20 minutes per session, using the CogniFit platform.
• Weekly remote, standardized one-on-one coaching focused on EF strategies.
• Analogue or non-digital games chosen for flexibility and home use.
• The intervention is described as adaptive to individual needs and aims to sustain motivation and engagement through a combination of digital and hands-on activities.
• A control group participated by maintaining activity logs rather than receiving the active multimodal program.

• Acceptability: Assessed with an Acceptance and Feasibility Scale and coach-rated engagement during coaching sessions.
• Demand: Quantified by completion rates across the three intervention components (computerized training, strategy coaching, analogue games).
• Implementation: Measured via an adherence-focused Fidelity Measurement System to determine whether core components were delivered as intended.
• Practicality: Assessed by the retention rate across the study timeline.
• Integration: Evaluated via integration items within the Acceptance and Feasibility framework to gauge home integration of the program.
• Exploratory efficacy outcomes: Included parent- and teacher-reported BRIEF indices and neuropsychological EF metrics, along with psychosocial variables, assessed at baseline, immediately after eight weeks, and at four months post-intervention.

• Recruitment and sample: The study enrolled 42 participants, of whom 20 were female.
• Acceptability and engagement: The program was deemed acceptable with moderate observed engagement during coaching sessions.
• Demand and usage:
• The median number of computerized training sessions completed was 16 out of 24 planned sessions, equating to 67% adherence (interquartile range 6 to 19 missing data implied).
• All participants attended every scheduled coaching session.
• Analogue game activities were completed a median of 9 sessions overall (interquartile range 4 to 14).
• Implementation fidelity: Coaching sessions were delivered as intended by the coaches, indicating feasible delivery in the studied setting.
• Practicality and integration: The overall retention rate stood at 90%, and E-Fit was described as well-integrated into participants’ home environments.
• Safety and data scope: Open data sharing was not planned due to sensitivity of patient information.
• Limitations related to feasibility assessment:
• Some participants and questionnaire administration occurred in the presence of investigators/coaches, which could introduce response bias.
• Recruited participants skewed away from low socioeconomic status groups, indicating recruitment challenges for more socioeconomically diverse populations.
• The study notes that motivation-related strategies for improving adherence to computerized training require refinement before a future, larger efficacy trial.

• The exploratory efficacy analyses suggested favorable trends for the intervention group in behavioral regulation and social responsiveness:
• Changes in parent-rated Behavioral Regulation Index of BRIEF showed improvements at both post-intervention and follow-up, with effect estimates indicating a potential negative direction (lower scores) consistent with improvement.
• Social responsiveness measures also demonstrated improvement trajectories at post-intervention and at follow-up.
• Quantitatively reported effects are presented as adjusted Hedge’s g values in the report, though the exact numerical figures are not provided here; the direction of effects favored E-Fit in these domains.
• It is important to emphasize that these findings are exploratory and not definitive, given the feasibility nature of the study and lack of prespecified efficacy endpoints or powered comparisons.

• Prior EF intervention literature in children with cCHD includes a small number of studies, with mixed results:
• Cogmed working memory training has yielded some short-term improvements in performance-based measures but not consistently sustained.
• A LEGO-based therapy approach showed early improvements in some EF domains but lacked follow-up data.
• The current study's rationale emphasizes addressing multiple EF domains through a multimodal strategy—combining cognitive training, strategy coaching, and analogue games—to potentially overcome the limitations of single-domain interventions.
• Broader evidence from other pediatric neurodevelopmental populations suggests that self-regulation strategy coaching combined with targeted training may yield beneficial effects, lending plausibility to the multimodal approach within a cCHD population.
• The intervention development incorporated stakeholder input from patients and families, emphasizing a person-centered design intended to sustain motivation and adherence.

While exploratory signals appeared favorable for certain domains, formal efficacy conclusions cannot be drawn.

Future work should address recruitment strategies to achieve more representative samples.

This should be mitigated in future trials through stricter blinding procedures where feasible.

If subsequent trials confirm efficacy, E-Fit could represent a scalable approach to supporting EF and social functioning in this high-risk group.

• Data completeness and reporting: As a feasibility study, the primary outcomes focus on feasibility parameters rather than definitive clinical efficacy.
• Adherence optimization: The main practical challenge identified relates to adherence with computerized training; targeted motivational strategies will be essential to improve engagement in a larger trial.
• Generalizability: Recruitment difficulties and under-representation of families from lower socioeconomic backgrounds temper generalizability.
• Blinding and bias considerations: Participants were unblinded after baseline assessment, and some instruments were completed during contact with investigators, introducing potential bias.
• Data sharing and privacy: Given the sensitive nature of pediatric clinical data, open data sharing was not pursued; researchers planning future work should balance transparency with privacy considerations and consider controlled access data models if appropriate.
• Practical relevance: The study concludes that E-Fit is feasible and integrates well into home settings, with indications that the multimodal approach can be implemented in a real-world context.

High retention and successful delivery of core components suggest practicality for future testing in larger samples or multi-centre settings.

These signals warrant careful evaluation in adequately powered efficacy trials.

• Feasibility profile: The E-Fit program demonstrated overall feasibility in a home-based, multimodal format for children with cCHD.
• Intervention components: The combination of computerised EF training, remote 1:1 strategy coaching, and analogue games appears deliverable and acceptable to families, with all coaching sessions consistently attended and a majority of training sessions completed.
• Early signals of benefit: Exploratory outcomes point toward potential improvements in behavioral regulation and social responsiveness, as reported by parents, at both the immediate post-intervention stage and at four-month follow-up.
• Next steps: Before proceeding to a definitive efficacy trial, refinement of adherence-enhancing strategies for computerized training is recommended, along with strategies to broaden recruitment to more diverse socioeconomic groups, and the implementation of rigorous blinding and bias-mitigation measures.

Specific numerical values for adjusted Hedge’s g estimates and exact BRIEF subscale changes were not provided here.

• The study did not publish numerical outcome data within this summary beyond qualitative direction and generalized effect descriptors.
• The source indicates that no open data sharing is planned due to privacy concerns, which constrains secondary analyses by external researchers.