Enhancing Social-Emotional Health and Wellbeing in the Early Years (E-SEE): A Study Protocol of a Community-based Randomised Controlled Trial with Process and Economic Evaluations of the Incredible Years Infant and Toddler Parenting Programmes, delivered in a Proportionate Universal Model

Abstract

Introduction:
Behavioural and mental disorders have become a public health crisis and by 2020 may surpass physical illness as a major cause of disability. Early prevention is key. Two Incredible Years parent programmes that aim to enhance child wellbeing and development, IY-Infant and IY-Toddler, will be delivered and evaluated in a proportionate universal intervention model called E-SEE Steps. The main research question is: Does E-SEE Steps enhance child social emotional wellbeing at 20 months when compared to services as usual?
Methods and analysis:
E-SEE Steps will be delivered in community settings by Early Years Children’s Services and/or Public Health staff across local authorities. Parents of children aged 8 weeks or less, identified by health visitors, children’s centre staff, or self-referral, are eligible for participation in the trial. The randomisation allocation ratio is 5:1 (intervention to control). All intervention parents will receive an Incredible Years Infant book (universal level), and may be offered the Infant and/or Toddler group-based programme/s - based on parent depression scores on the Patient Health Questionnaire (PHQ-9) or child social emotional wellbeing scores on the Ages and Stages Questionnaire – Social Emotional (ASQ:SE-2). Control group parents will receive services as usual. A process and economic evaluation are included. The primary outcome for the study is social emotional wellbeing, assessed at 20 months, using the ASQ:SE-2. Intention-to-treat and per protocol analyses will be conducted. Clustering and hierarchical effects will be accounted for using linear mixed models.
Ethics and dissemination:
Ethical approvals have been obtained from the University of York Education Ethics Committee (ref: FC15/03, 10th August 2015) and UK NHS REC 5 (ref: 15/WA/0178, 22nd May 2015. The current protocol is Version 9, 26th February, 2018. The sponsor of the trial is the University of York. Dissemination of findings will be via peer-reviewed journals, conference presentations and public events.