Title: 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
Funder: Department of Health and Social Care

Abstract: 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.

Lay abstract: Background: Behavioural and mental health disorders have become a public health crisis and by 2020, are likely to surpass physical illness as a major cause of disability. The home environment, and particularly parent practices, and mental health (of both mothers and fathers), can impact significantly on a child’s social and emotional competence, behaviour, and outcomes in later life (e.g. educational attainment, the ability to form secure relationships, likelihood of criminality or drug or alcohol misuse, and mental health). Considerable evidence shows that early mental health promotion is more effective, and less costly, than late intervention. A recent Cochrane review showed that group-based parenting programmes for parents of children with conduct problems aged 3-12 years were effective (and cost-effective) in enhancing children’s social and emotional wellbeing and behaviour, and positive parenting skills/practices, while reducing parental depression, stress, and negative parenting. A similar review for parents of younger children (0-3 years),coupled with recent NICE guidance,highlight a pressing need for much more evidence on the effectiveness of such programmes in the very early years. This study will address an important knowledge gap by investigating, in the short, medium and (possibly) longer term, the potential of two new Incredible Years (IY) parent programmes for the ‘under twos’. Outline of the grant application: The aim of this project is to establish the effectiveness, acceptability and cost-effectiveness of the IY Infant (IY-I) and IY Toddler (IY-T) Parent Programmes in enhancing social and emotional wellbeing in children under two. There is compelling evidence from research in England, Wales and Ireland and internationally showing that the BASIC IY programme (for parents of children aged 3+ years) enhances child (and parent) wellbeing. However, the more recently developed IY-I and IY-T programmes for 0-2 year-olds have not yet been rigorously evaluated in England; although encouragingly a small trial in Wales, and one in Boston, US, showed promising results. Primary carers of infants of approximately two months of age will be identified and the study explained to them. Primary carers who consent to take part will be randomly allocated to receive IY (the intervention) or to continue using services as usual (forming a comparison group). Intervention parents may receive different ‘doses’ of IY according to their level of need. All intervention families will initially receive an IY book as a universal level; at the next level those identified as requiring additional support (using parent mental wellbeing) will receive the 10-week (2hrs/week) IY Infant parent programme. Families identified as needing further support when children are approximately 12 months may also receive the 12-week (2hrs/week) IY Toddler parent programme. Primary outcomes will be assessed when children are approximately 20 months old: 1. Child social and emotional wellbeing 2. Parent wellbeing Other outcomes of interest include parenting skills/confidence; parent-child attachment/interaction; use of health and social services; child behaviour; child language; quality of life and cost. How successfully the programme doses are implemented and received are also of interest. We will undertake a 18-month randomised pilot in two Local Authorities (LAs), followed by a 30-month main randomised trial in four LAs. Of specific interest is how to maximise the participation of co-parents/other significant carers (e.g. fathers and grandparents) and to establish their impact on child wellbeing.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: MENTAL HEALTH