A randomised controlled clinical and cost effectiveness trial of an online integrated bipolar parenting intervention (IBPI) compared to treatment as usual in improving child emotional and behavioural outcomes: a study protocol

Abstract

Background
Bipolar disorder (BD) is a severe mental health problem linked to substantial personal and social costs. Many individuals living with bipolar disorder are parents. Due to the nature of the condition, parents with BD often experience challenges in delivering consistent parenting. In addition, up to 60% of their children experience at least one mental health problem in childhood and are at increased risk of future severe mental health problems including bipolar disorder. This paper describes the rationale and protocol for a definitive randomised controlled trial of a new digital intervention (Integrated Bipolar Parenting Intervention; IBPI) to support effective parenting in the context of BD.

Methods and Design
The randomised controlled clinical and cost-effectiveness trial compares IBPI plus treatment as usual (TAU) with TAU alone. Parents with BD with a child aged 4-11 years old and living in the UK will be recruited through the NHS, mental health charities, and social media. Participants will be screened to confirm a clinical diagnosis of BD. They will then complete baseline assessments and be randomised to receive either IBPI+TAU or TAU with follow up assessments after 24- and 48- weeks. The primary clinical outcome is child emotional and behaviour problems measured by the Strengths and Difficulties Questionnaire at 24 weeks. The primary economic evaluation will be a cost-utility analysis at 24-weeks with quality-adjusted life years (QALYs) measured using the Child Health Utility 9 Dimensions measure of health-related quality of life. Secondary outcomes include parental mood and confidence and family functioning at 24- and 48- weeks, and child emotional and behavioural problems and health economic outcomes at 48 weeks.

Discussion
Despite the challenges faced by children of parents with BD and the parents themselves, research on how to improve their lives is lacking. This will be the first definitive trial of a tailored intervention that aims to improve child and parent outcomes. Results will be reported in line with CONSORT guidance for clinical and health economic findings.