Enhancing Social-Emotional Health and Wellbeing in the Early Years: A Community-based Randomised Controlled Trial (and Economic) Evaluation of the Incredible Years Infant and Toddler (0-2) Parenting Programmes

Background: Behavioural and mental health disorders have become a public health crisis and by 2020 may surpass physical illness as a major cause of disability. There is a strong causal link between parent and child wellbeing. Incredible Years (IY) group-based parent programmes aim to promote social & emotional wellbeing in children aged 0-12 years (http://incredibleyears.com/).Robust evidence for IY with parents of children aged 3+ years demonstrates increased child social and emotional wellbeing, fewer behavioural difficulties, and importantly, a positive impact on parent wellbeing - a major risk factor for healthy child development. Few programmes, and little evidence, currently exists for ehancing social emotional wellbeing in the 0-2 year age range. Two newly developed IY programmes for parents of 0-2 year-olds, IY-Infant (IY-I) and IY-Toddler (IY-T),have not been rigorously evaluated in targeted large-scale randomised controlled trials. We propose delivering IY as a proportionate universal intervention based on assessment of risk/need, to include, prior to IY programme delivery, a low-level universal dose comprising of the IY-I book. Main research question: Are the IY-I book,IY-I and IY-T programmes, when delivered in a dose proportionate to need,and when compared to services as usual, effective and cost-effective in enhancing child social and emotional wellbeing at 20 months of age? Setting: The intervention will be delivered in community settings,such as children or community centres,by local children and family service and health staff across four Local Authorities (LAs). Participants: Parents of children aged 0-2 months at baseline, will be identified by children centre staff, self-referral,Health Visitors,with additional research awareness activities being conducted by our parent committee. Primary carer level of need will be assessed by completion of a mental health questionnaire. Co-parents/significant carers will be included in measure completion (and intervention levels if primary carer is allocated to intervention condition). Design: An 18-month internal randomised pilot study,leading to a definitive 30-month randomised controlled trial. The Trials Unit will randomise participants following baseline assessments, to intervention or control on a 2.9:1 ratio (respectively), stratified according to level of need based on primary carer depression scores, and gender of child and primary carer. Intervention parents will receive an IY-I book (universal level), followed by an IY-I (8-10 weeks, 2 hours/week),and/or IY-T (12 weeks, 2 hours/week) dependent on level of need at data collection points 2 and 3. Control parents will receive services as usual (SAU).IY-I and IY-T will not be SAU in participating LAs. Outcomes: Primary outcomes assessed at final follow-up when child is 20 months old: 1. child social and emotional wellbeing using a validated assessment tool (e.g. Ages and Stages Questionnaire - Social Emotional version). 2. Primary parent depression/wellbeing levels using a validated assessment tool (e.g. PHQ9). Measures will be administered during home, or community-based, visits at four intervals, baseline and 3 follow-ups (2, 9, 18 months post-baseline). The IY interventions (IY-book, IY-I, and IY-T) will be delivered in the interim periods between data collection points. Implementation fidelity and cost-effectiveness will also be evaluated. Intention to treat (ITT) and per protocol analyses will be conducted. Clustering and hierarchical effects (e.g. LA) will be accounted for using linear mixed models. Potential confounding factors (demographic variables) will form co-variates in the analysis. Timetable This is a 4.5 year project,including a 1.5 year internal pilot.