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Active TRAINING NIHR Open Data-Funded Portfolio

Refining, testing and targeting an intervention to support the early development of Executive Functions amongst infants at elevated likelihood of autism and/or ADHD

£7.69M GBP

Funder National Institute for Health and Care Research
Recipient Organization University of Oxford
Country United Kingdom
Start Date Mar 01, 2021
End Date Sep 30, 2026
Duration 2,039 days
Number of Grantees 2
Roles Award Holder
Data Source NIHR Open Data-Funded Portfolio
Grant ID NIHR300880
Grant Description

Background Executive Function (EF) difficulties are common amongst individuals with autism and/or ADHD (and their relatives), and are linked to poor mental health and lower quality of life.

EF is amenable to change through intervention but may be most effective early in development, if embedded in day-to-day contexts.

Aims Refine a parent-mediated early-EF-enrichment intervention programme to meet the needs of families with a connection to autism and/or ADHD Test the feasibility of a Randomised Controlled Trial of the intervention Establish how to target the intervention towards infants most in need of EF support Methods and deliverables Work package (WP) 1: Intervention refinement (Months 1-11) Four intervention co-refinement sessions with parents with a connection to autism/ADHD Community consultation on project aims, target outcomes and documentation Progression criteria defined for WP2 WP2: Intervention feasibility (Months 12-20) Recruitment of intervention participants Two pairs of early-years practitioners trained in intervention delivery Revised 12-week programme delivered to 2 groups of 6 infant-parent-dyads (infants aged 16-22 months) with a Familial History of autism/ADHD (FH-autism/ADHD) Sessions coded for fidelity Post-session parent and practitioner questionnaires assessing understanding, enjoyment and implementation Intervention further refined or progressed to feasibility trial Progression criteria defined for WP3 WP3: Trial feasibility (Months 18-67) Recruitment of intervention participants Two new pairs of early-years practitioners trained in intervention delivery 60 infant-parent-dyads: FH-autism/ADHD infants aged 16-22 months cluster-randomised in groups of around 6 to intervention arm (revised early-EF-enrichment programme) or control arm (matched for structure and intensity) 10% of intervention sessions coded for fidelity to the manual/contamination Post-programme parent and practitioner questionnaires assessing understanding, enjoyment and implementation Assessment of infants' EF, cognitive ability and autism traits at 16 months (pre-intervention), 24 months (outcome) and 30 months (online follow-up) Reviewed against progression criteria for acceptability, scaleability, suitability of trial design, replicability and selection bias Welch's t-test comparing group means for attention and EF composite scores at 16 months between both arms of the intervention sample, and an age-matched control sample (no FH-autism/ADHD; recruited for an ongoing study, N=190); evaluating the extent of EF difficulties in a non-selective sample of FH-autism/ADHD infants Repeated-measured ANOVAs (pre-intervention and outcome) and Welch's t-tests (follow-up); testing for preliminary evidence of efficacy and effectiveness Mediation analysis of parent sensitivity at 24 months; testing the mechanism of change WP4: Targeting criteria (Months 1-44) Infants with and without FH-autism/ADHD, from ongoing studies (n=490) and new online sample (n=50) Socio-economic status, birth characteristics and family history collected at study entry (10-16 months) Parent-report of EF (BRIEF-P) collected at 30 and/or 36 months Multiple-regression analysis of socio-economic status or birth characteristics as a predictor of EF difficulties, and the moderating effect of FH-autism/ADHD on these effects Impact and dissemination Results of the case-series (WP2), feasibility (WP3), and risk-factor (WP4) studies will be submitted to peer-reviewed journals and conferences, and summarised in newsletters to participants and stakeholders.

The project will inform a funding application for a definitive multi-site trial of the intervention, which could be rolled out for national dissemination via the Peep Learning Together Programme.

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University of Oxford

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