Title: Long term effectiveness and cost-effectiveness of early mental health intervention: Follow up to the Healthy Start, Happy Start study
Funder: Department of Health and Social Care

Abstract: Behaviour problems are common and often start in early childhood. Children with persistent problems are at a higher risk of short- and long-term mental and physical health problems, as well as educational and social difficulties as they grow up. Parenting programmes are a key way of helping families. Providing this support early in childhood should have long lasting benefits for children’s health and development. However, few studies have looked at whether the benefits of parenting programmes are short lived or continue to be helpful as children grow older._x000D_ _x000D_ This study is a follow up to the Healthy Start, Happy Start study, which examined the effectiveness of a brief parenting programme (Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline; VIPP-SD) for one and two year olds showing early signs of behaviour problems (e.g., impulsivity, tantrums, and aggression). Following up the Healthy Start, Happy Start children now when they are approximately 7 years old will allow us to answer two important questions. Firstly are the initial benefits of the VIPP-SD programme maintained into middle childhood? Secondly is the VIPP-SD programme good value for money? Answering these questions is important as this is the first opportunity to test whether an effective early intervention for children’s mental health continues to make a difference to children, families, society and the NHS in the long term._x000D_ _x000D_ A total of 300 families in the UK took part in the original trial and most families (94%) remained involved throughout. We visited all families when the study started and 5 and 24 months later to see if children whose families received the VIPP-SD programme showed fewer behaviour problems than those whose families did not. We found that children in the VIPP-SD group had lower levels of behaviour problems following the programme, compared to children whose parents did not receive the programme. It was difficult to measure the value for money of the programme compared with routine services in the original study because families tend to use services when their children are older and problems have become more established. Most studies of value for money also use a common measure for assessing the benefits of health interventions and this measure was not designed to be used in children under the age of six._x000D_ _x000D_ As the children are now older, this new follow up study will allow us to answer the questions about whether the VIPP-SD programme creates lasting benefits and whether it is good value for money. We will ask caregivers to complete an interview and questionnaires about their children’s behaviour and wellbeing and their use of health services to help us calculate the costs of supporting these children. We will also ask teachers and children themselves to provide information on children’s development and behaviour to build up a more complete picture about how children are getting on in school and at home._x000D_ _x000D_ This study team includes two parent representatives who have advised the Healthy Start, Happy Start study since it started. We will also bring together a larger panel of parents as well as a children’s panel to advise on the information we provide to children and families, the study methods, and how best to communicate the findings to participants and the public. We will share the study’s findings widely with other researchers, policy makers, NHS staff and service commissioners, and the charity sector.

Lay abstract: We propose a long-term follow up of a HTA-funded randomised controlled trial (Healthy Start, Happy Start; HSHS). The study will assess the long-term clinical- and cost-effectiveness of a brief parenting intervention (Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline; VIPP-SD) on behaviour problems in children. The original RCT is the first pragmatic UK trial to demonstrate a benefit of intervention for very young children at risk of behaviour problems._x000D_ _x000D_ Research questions_x000D_ 1) Is an early psychological intervention (VIPP-SD) effective in reducing children’s behaviour problems in the long-term, compared to usual care?_x000D_ 2) Is an early psychological intervention (VIPP-SD) cost-effective compared to usual care in the long-term, in terms of quality adjusted life years (QALYs)?_x000D_ _x000D_ Background_x000D_ Behaviour problems affect 5-10% of children. Children with enduring behaviour problems have an increased risk of health and social problems throughout life, including psychiatric disorders, educational failure, physical ill health and antisocial behaviour. The lifetime costs of behaviour disorders are so high that even modest effects of early intervention are likely to produce a positive return on investment. Early intervention has thus become a key focus of NHS policy and practice. This study provides a unique opportunity to determine whether effective early intervention provides sustained benefits for children’s mental health and cost savings to the NHS and wider society._x000D_ _x000D_ Aim_x000D_ To evaluate the long-term (5 years post-randomisation) effectiveness and cost-effectiveness of a brief early parenting intervention (VIPP-SD), designed to reduce behaviour problems, compared to usual care._x000D_ _x000D_ Objectives_x000D_ 1.To assess whether, compared to usual NHS care, VIPP-SD leads to long-term lower levels of behaviour problems in children who are at high risk of developing these problems (5 years post-randomisation – children aged 7 years old)._x000D_ 2.To undertake an economic evaluation to assess the cost-effectiveness of VIPP-SD compared to usual care in the long-term._x000D_ 3.To obtain and utilise routinely collected health and education data to supplement and further inform the effectiveness and cost-effectiveness objectives above._x000D_ _x000D_ Methods_x000D_ We will collect 5 year follow-up data from participants (N=300) of HSHS, a two-arm RCT comparing VIPP-SD to usual care. 94% of the sample were retained at the 2 year follow up with outcome data available on 98% of children at one/both follow-up points. The primary outcome is children’s behaviour problems measured by parent interview; secondary outcomes include parent-reported service use, the Child Health Utility Index, and routine health and education records where available. As the sample size is fixed (minimum expected N = 256) we will use a Bayesian analysis framework to calculate the posterior probability that the intervention retains superiority at 5 year follow up. Cost effectiveness will be assessed in terms of quality adjusted life years._x000D_ _x000D_ Timelines_x000D_ November 2021 for 20 months._x000D_ _x000D_ Impact and dissemination_x000D_ This will be the first UK study to determine whether effective early intervention prevents enduring mental health problems for children, provides significant cost savings, and should be offered as part of NHS care. Our team, including significant PPI input, has a successful track record of dissemination. Our strategy includes outputs targeting policy, practice, academic and public audiences.

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