Title: A feasibility study of a Randomised Controlled Trial of a Family Focused Treatment (FFT-A UK version) in the management of Early Onset Bipolar Disorder (EOBD) (aged under 18 years).
Funder: Department of Health (England)

Abstract: Background Bipolar Disorder ( BD ) is a mood disorder characterised by significant and disabling mood fluctuations with periods of remission. The typical age of onset is considered to be between 20-30 years. However there is increasing evidence that the onset of mood symptoms can occur earlier [37]. Early onset Bipolar Disorder EOBD (under 18 years) is associated with considerable impairment in emotional, cognitive and social development [9]. Young people, if left untreated are at risk of school failure, rejection by peers, physical injury, substance abuse and even suicide.[47]. Medication has been considered the mainstay of treatment both for acute mood episodes and during the maintenance phase in EOBD . NICE Bipolar guidelines [36] note that the involvement of families is important in the management of young people with EOBD and recommend psychological interventions of around 16 sessions over 6-9 months in combination with psychopharmacology . There is a limited evidence base from the USA with regards to psychotherapeutic treatment options for young people with EOBD [32,46,47,22]. To our knowledge there are no UK studies. The aim of this research is to establish the feasibility and acceptability of a family focused treatment in the management of EOBD. If found to be effective the treatment should increase understanding of BD for adolescents and their families and enhance communication within the family. Furthermore we aim to assess the attitudes of young people and their families towards the requirements of research participation. Primary Aim To examine the acceptability of using a family focused treatment ( FFT -A UK version) (adapted from Family Focused Treatment- Adolescent [30] as an adjunct to pharmacotherapy with families living in the North East of England. The acceptability will be assessed quantitatively by monitoring recruitment and attrition rates and qualitatively by semi structured interviews and a focus group for young people and their families. We will look for evidence of particular challenges in delivering the intervention, such as, attitudes to being randomised and to the possible delay in receiving the intervention. Plan of Investigation 33-34 families (to allow for a 10% attrition) in the North East living with a young person with EOBD will be recruited to take part in this feasibility trial of FFT A UK version . Eligibility criteria include family members living with or involved in the care of a young person (aged 11-18 years) diagnosed with BD . Families, following fully informed consent/assent will complete baseline questionnaires. Families will then be randomised to intervention or treatment as usual. The therapy consists of 3 modules, psycho-education, communication enhancement and problem solving skills training. The intervention will consist of 16 hour long sessions (7 weekly, 9 fortnightly) over approx 6 months as recommended by NICE Bipolar Guidelines. David Miklowitz will train and supervise the therapists on the FFT-A and perform fidelity rating checks. Quantitative outcomes will be measured using validated questionnaires at baseline, following intervention and after six months. Intervention and trial acceptability will be assessed through qualitative interviews and a focus group immediately following the intervention. Potential benefits The data from this feasibility study will determine if this intervention for EOBD is feasible and form the basis for an adequately powered multi -centre RCT to evaluate clinical effectiveness and cost-effectiveness, that takes account of the views and experience of patients and their families. This psychotherapeutic treatment can (after adequate training and supervision) be delivered by a diverse range of health professionals. All these factors would justify its use in the NHS within an assessment and management pathway for EOBD .


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