Clinical and cost effectiveness of an online integrated bipolar parenting intervention: A randomised controlled trial

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)? Background 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. 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. 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. 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. 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.