Title: Clinical and cost effectiveness of an online integrated bipolar parenting intervention: A randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Aim _x000D_ We aim to assess whether providing parents with bipolar disorder (BD) with online parenting support leads to their children having fewer behaviour problems. We also want to know whether this helps parents feel less stressed and more confident about their parenting. We will also explore whether the intervention leads to parents having fewer mood or anxiety problems._x000D_ Background_x000D_ Parents with BD find that the ups and downs of mood that they experience make parenting very challenging particularly providing the consistent support and guidance children need. Parents with BD want parenting support, but worry they might lose access to their children if they disclose this to their clinicians. Accessible, flexible, and confidential online parenting support is a way to provide this without adding to worries parents already have. Children of parents with BD often have emotional and behavioural problems, which can lead to severe mental health problems, including BD, as they grow up. Parents need support to help their children flourish, which may help parents themselves feel better as well, with wider benefits for society. Our team have built an online intervention to support parents with BD which was acceptable to parents and helped with child emotional and behaviour problems and with parenting. We now need to fully assess whether an updated version of this intervention is effective and represents value for money. _x000D_ Design and method _x000D_ Parents with BD with a child aged 4-10 years old in the UK will be invited to participate through UK NHS mental health trusts, mental health charities and social media. Three hundred and forty two parents who agree to take part will be either offered the online intervention, or usual care. Whether the parent receives the intervention or not is decided by randomisation (like a coin toss). Parents will fill in questionnaires about their child, their parenting, their mood and anxiety when they start the study and at 24 and 48 weeks. Up to thirty parents will be interviewed after taking part in the intervention to learn their views._x000D_ Public and patient involvement (PPI)_x000D_ Parenting in BD needs to be addressed in an inclusive, sensitive and cooperative manner. Involvement of parents with lived experience is therefore crucial. Parents with BD were integral to the development and testing of the intervention in our previous study. A member of our team with lived experience of BD will lead on coordinating input from parents with BD throughout this study. He will form a parent advisory group of 8 parents with BD which will meet at the beginning of the study and monthly throughout to ensure PPI input into updating the intervention, how the study is run and how the results are shared. We have already consulted with parents with BD to confirm their support for the intervention and to understand how much change in their child’s problems would need to be achieved by the intervention for them to think it worthwhile. _x000D_ Dissemination _x000D_ We expect a lot of interest in the results of this study as this is the first online intervention for this under-served group. To maximise the impact of the research we will work with NHS trusts, Bipolar UK (national charity) and parents with BD to ensure the updated intervention is fit for purpose and can be rapidly rolled out nationally if effective.

Lay abstract: Research Question - What is the clinical and cost effectiveness for children of parents with BD aged 4-10 (Population) of integrated bipolar parenting intervention (IBPI) plus treatment as usual (Intervention) versus treatment as usual (Control) on child behavioural and emotional problems (Outcome)?_x000D_ Background _x000D_ Bipolar disorder (BD) is a potentially lifelong severe mental health issue linked to substantial personal and social costs. Recent estimates indicate annual costs to the economy of £5.2 billion increasing to £8.2 billion in the next 5 years without improvements in support. These estimates do not include the impact on children of parents with BD. Parents with BD often experience challenges in delivering consistent constructive parenting and up to 60% of their children experience at least one mental health issue in childhood as well as being at increased risk of future severe mental health problems including BD. Parents with BD need support with parenting their children to improve child mental health outcomes with potential benefits for parental mental health and wider society. We have worked with parents with BD to co-develop the Integrated Bipolar Parenting Intervention (IBPI) and evaluate the feasibility of online support designed specifically for them. In a feasibility trial of 97 participants we demonstrated IBPI is acceptable, feasible and safe with potential benefits for child emotional and behavioural problems and improved parenting. It is now necessary to determine definitively the clinical and cost efficiency of IBPI. _x000D_ Aims and Objectives: We aim to evaluate whether IBPI plus treatment as usual (TAU) is effective and cost effective in improving child emotional and behavioural problems compared to TAU alone in a national online trial. The primary objective is to recruit 342 eligible parents with BD randomised to receive either IBPI plus TAU or TAU alone, and to compare outcomes for children and parents over up to 48 weeks. _x000D_ Methods: Parents with BD with an index child aged 4-10 years old and living in the UK will be invited to participate through NHS, mental health charities and social media. Participants will be screened to confirm clinical diagnosis and complete baseline assessments, then randomised to IBPI or TAU groups. Follow up assessments will be completed online at 24 and 48 weeks. Primary outcomes at 24 weeks: i) clinical - child emotional and behaviour problems measured by Strengths and Difficulties Questionnaire: ii) health economic - costs and quality of life years (QALYS) using Child Health Utility 9D._x000D_ Timelines of delivery: Months 1-6 Optimise IBPI platform and finalise digital data capture; 7-15 IBPI launched and internal pilot conducted with STOP-GO outcome at month 15. 16-42 months recruitment to final total and final follow-ups. 43-48 months analysis, write up, dissemination and implementation._x000D_ Anticipated impact and dissemination: Despite the challenges faced by children of parents with BD research on how to improve their lives is lacking. This will be the first definitive trial of a tailored intervention to improve their outcomes and will be a crucial addition to the evidence of what works to improve the lives of people with BD and their families. If effective, IBPI can readily be rolled out nationally. This work will be disseminated through conference presentations, peer reviewed papers, plain English summaries and use of animation and video to engage professional, patient and public groups.

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