Title: Preventing enduring behavioural problems in young children through early psychological intervention: Healthy Start, Happy Start
Funder: Department of Health and Social Care

Abstract: DESIGN: The study is a two-arm, parallel group, individually randomised controlled trial. SETTING: NHS primary health care settings in North London and Milton Keynes. Recruitment will take place via health visitor services. STRATEGY FOR REVIEWING LITERATURE: We have undertaken a systematic review of the available literature on early interventions for behavioural problems, including published systematic reviews, ongoing registered trials, and contact with experts in the field who are currently undertaking studies. TARGET POPULATION: Children aged 12-36 months old, who have been identified as at risk for behavioural problems by parental questionnaire, and their parents/caregivers. INCLUSION CRITERIA: i) child aged between 12-36 months; ii) child scores in the top 20% for behavioural problems on the Stregnths and Difficulties Questionnaire. EXCLUSION CRITERIA: i) index child has severe sensory impairment or learning disability; ii) carer has insufficient English to complete questionnaire assessments. HEALTH TECHNOLOGIES BEING ASSESSED: Video-Feedback to Promote Positive Parenting and Sensitive Discipline (VIPP-SD). We have selected this intervention as it has been developed and evaluated in a systematic way, and has a strong developing evidence base for early preventive intervention. It is a home-based, highly acceptable intervention, delivered over 6 sessions, at approximately fortnightly intervals. The intervention will be delivered to the primary caregiver, and to a second parent/carer as well if they are available. In addition, those in both the treatment and control arms will continue to receive usual care. MEASUREMENT OF COSTS AND OUTCOMES (PLUS JUSTIFICATION FOR THESE): The primary outcome will be Child Behaviour, assessed through a structured interview with the child’s parents/guardians (Pre-PACS interview). Secondary outcomes will include: Child Behaviour measured with the Child Behavior Checklist, a standard questionnaire measure completed by parents and a non-parental carer or teacher; Parental Mood (Beck Depression Inventory); Parental Relationship (Dyadic Adjustment Scale); Parenting Practice (Parenting Scale); and costs of care measured using the Child and Adolescent Service Use Schedule (CA-SUS). SAMPLE SIZE: A total sample of 300 families will be recruited. This will provide power to detect a standardized effect size in the range 0.34 - 0.42. This is a similar effect to that found in previous trials and would be a highly clinically relevant difference so early in childhood, and is likely to map onto large differences in outcome in later childhood and adult life. PROJECT TIMELINES INCLUDING RECRUITMENT RATE: 0-4 months. Set up study, recruit and train staff. Ethical and local R&D approvals will already have been sought. 5-25 months. Recruit participants. Deliver index treatment and control intervention. Recruitment period of 21 months at average rate of 14.2 participants per month. 9-49 months. Follow-up assessments at 4 and 24 months post-randomisation. 48-54 months. Analysis of findings and writing of final report and papers. EXPERTISE IN TEAM: This proposal is submitted by a multidisciplinary team which includes expertise in child mental health, parenting and early intervention research, mental health services research, statistics and health economics, and has the active involvement of a registered Clinical Trials Unit and voluntary parenting organisations.

Lay abstract: Behavioural problems are common and important. They affect 5-10% of children, and children with established behavioural problems have significantly worse outcomes that persist through childhood and into adult life. They have an increased risk of psychiatric disorders, antisocial behaviour and criminality, drug and alcohol misuse, educational failure and physical ill health. As well as these high levels of difficulties and unhappiness for young people and their families, there are also large costs incurred by society through the health, social care and criminal justice systems. A key risk factor for the development of behavioural problems is the quality of the parental care that children receive: low levels of sensitive parenting and greater use of harsh discipline have been causally linked to the development of behavioural problems. Interventions which work with parents and carers to improve their parenting have been found to reduce child behavioural problems, and intervening early in children’s lives has the potential to be particularly effective in improving outcomes, as well as having beneficial effects for parental health and wellbeing. However, most research to date has focussed on older children, when behavioural problems are more established, and thus more difficult to treat. Interventions have also focussed predominantly on mothers, with very few interventions involving fathers or a second caregiver, despite accumulating evidence that interventions involving two parents or caregivers can be more effective than those engaging just one. The proposed intervention has a developing evidence base as an early preventive intervention. The aim of this study is to evaluate a brief, early parenting intervention (Video-Feedback to Promote Positive Parenting and Sensitive Discipline; VIPP-SD) which aims to reduce behavioural problems in 12-36 month old children who are at significant risk of developing externalising behavioural problems. It is a home-based intervention which will be delivered by experienced health visitors to the primary caregiver, and to a second parent or carer if present. VIPP-SD is designed to improve parents’ sensitivity in interactions with their infants and to improve their ability to manage their children’s positive and negative behaviour. It has been adapted from an existing evidence-based intervention, which has been found to improve mothers’ sensitivity in interactions with their infants and mother-infant attachment. The intervention has a strong focus on reinforcing positive interactions and positive parenting. The intervention will be compared to a control condition in which parents receive treatment as usual from their health visitors and other appropriate NHS services. The proposed research will be the first large randomised controlled trial to test whether an early video-feedback intervention is an effective and cost-effective approach to reducing behavioural problems in at-risk young children. It addresses an area of key concern to the NHS and represents an opportunity for effective and cost-effective intervention to reduce the burden of behavioural problems on individuals, families and society. If shown to be effective the intervention could be delivered widely across the NHS to parents and carers of young children at risk of behavioural problems as part of primary care services.

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