RT Journal Article
SR Electronic
T1 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
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e026906
DO 10.1136/bmjopen-2018-026906
VO 8
IS 12
A1 Tracey Bywater
A1 Vashti Berry
A1 Sarah Louise Blower
A1 Judith Cohen
A1 Nicole Gridley
A1 Kathleen Kiernan
A1 Laura Mandefield
A1 Amanda Mason-Jones
A1 Sinead McGilloway
A1 Kirsty McKendrick
A1 Kate Pickett
A1 Gerry Richardson
A1 M Dawn Teare
A1 Louise Tracey
A1 Simon Walker
A1 Karen Whittaker
A1 Jessica Wright
YR 2018
UL http://bmjopen.bmj.com/content/8/12/e026906.abstract
AB 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 (IY) parent programmes that aim to enhance child well-being and development, IY Infant and IY Toddler, will be delivered and evaluated in a proportionate universal intervention model called Enhancing Social-Emotional Health and Wellbeing in the Early Years (E-SEE) Steps. The main research question is: Does E-SEE Steps enhance child social emotional well-being at 20 months when compared with 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 or child social emotional well-being scores on the Ages and Stages Questionnaire: Social Emotional, Second Edition (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 well-being, 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, 10 August 2015) and UK NHS REC 5 (ref: 15/WA/0178, 22 May 2015. The current protocol is Version 9, 26 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.Trial registration number ISRCTN11079129; Pre-results.