Title: Refining, testing and targeting an intervention to support the early development of Executive Functions amongst infants at elevated likelihood of autism and/or ADHD
Funder: Department of Health and Social Care

Abstract: 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 supportMethods and deliverablesWork 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 WP2WP2: 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 WP3WP3: 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 changeWP4: 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 effectsImpact and disseminationResults 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.

Lay abstract: In combination, autism and Attention Deficit Hyperactivity Disorder (ADHD) affect around 2.5% of UK children. Autism and ADHD often co-occur and cluster in families; a child with an autistic close relative is more likely than average to have ADHD, and vice versa. Executive Functions (EFs) are the skills that enable us to resist acting on impulse, adjust our actions during a changing situation, and work towards goals. EF difficulties are common amongst people with autism and/or ADHD, and amongst their relatives (even those without a clinical diagnosis). EF difficulties hamper individuals' ability to cope with everyday situations, which negatively impacts on their quality of life and their mental health. My research has shown that EF difficulties emerge in toddlerhood for some children with a family connection to autism/ADHD, and are linked to poor attentional control. By providing extra early support, we may be able to avoid some difficulties otherwise experienced by these children. To do this we need to know how to promote early EF development, and how to identify children most at risk for early EF difficulties (so we can support those children specifically). Last year, I collaborated with Peeple, a charity that trains over 1000 practitioners annually to help parents support their child's development. Together, we created and piloted a 12-week programme for 16- to 22-month-olds which promotes parental behaviours linked to strong EF development, whilst providing play-based opportunities for toddlers to develop their EF skills. During my Fellowship, I will refine this programme to meet the needs of infants with a family connection to autism/ADHD by creating alternatives for activities with high sensory or social demands, providing additional support for parents with EF or social-communication difficulties, and developing group discussion points to promote peer-support. This will be done in collaboration with parents who have autism/ADHD, and/or a child with autism/ADHD. Not only is co-development ethically preferable - 'nothing about us, without us' -h; it is also likely to maximise the uptake and effectiveness of the intervention. I will then test whether the adapted programme is fit-for-purpose by running it with 2 groups of parents and toddlers (aged 16-22 months) with a family connection to autism/ADHD. I will collect parents' and practitioners' feedback on whether the programme is feasible to run, enjoyable and perceived to have a positive impact. On the basis of this evidence, the intervention will be further refined if necessary. Next I will assess whether a full evaluation of the intervention is practical and justified. Sixty parents and toddlers will be randomly assigned in groups of around 6 to the early-EF-enrichment intervention, or a comparable programme targeting different skills. If the intervention does have a positive effect on EF, these benefits may fade over time, or take a while to become evident. Therefore toddlers will be followed up at ages 24 and 30 months. I will use the data collected to further refine the programme and to estimate how many participants would be required for a more-robust evaluation. This will inform a funding application for a full trial, to be submitted at the end of the Fellowship. In parallel, to identify how to most-effectively target the intervention, I will test whether known risk factors for poor EF in the general population -h; such as poverty and birth complications -h; interact with a familial history of autism and/or ADHD to increase the likelihood of EF difficulties. This study will use existing datasets, combined with a new online sample, to maximise value for money. All the above will be carried out in consultation with a community Advisory Group, and under the guidance of a cross-disciplinary Steering Committee.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH