title: A feasibility study of a Family Focused Treatment for Adolescents with Bipolar Disorder-the FAB study.
abstract: BACKGROUND
  The aim of this study is to examine the feasibility of a future definitive randomised controlled trial of Family Focused Treatment for Adolescents UK (FFT-A UK) in the management of early-onset bipolar disorder (EOBD) (under 18 years). The FFT-A has been evaluated in the USA to augment the pharmacological treatment of adolescents with bipolar disorder (BD). The FFT-A UK has been condensed to 16 sessions over approximately 6 months to be utilised within the UK National Health Service. Research from the USA suggests that families experience high levels of distress, stress, burden and family disharmony when living with a young person who has BD. The FFT-A UK is a family-based approach designed to increase understanding of BD (psycho-education), improve communication and increase ability to problem-solve.
  
  
  METHODS
  The trial will examine the feasibility of a randomised, parallel group, non-blinded design and the procedures of a subsequent definitive trial. Thirty-three young people with BD and their families will be recruited. Participants will complete measures at baseline, on completion of the 6-month treatment and again after a further 6 months. The self-report measures include the Warwick Edinburgh Mental Well-being Scale, The McMaster Family Assessment Device (FAD), Conflict Behaviour Questionnaire aka 'Interaction Behaviour Questionnaire', EuroQuol EQ-5D-3L and EQ-5D-Y. Primary outcomes will be rates of eligibility, recruitment and retention, estimates of the variability in the self-report measures and assessment of the intervention delivery in the study population. Participants' qualitative views on the measures and intervention will be sought to confirm the acceptability of intervention and study design. The health economics component will establish how cost-effectiveness will be assessed in a future definitive trial.
  
  
  CONCLUSIONS
  The study will produce a full trial protocol and amendments to the FFT-A UK to inform a well-designed multi-centre randomised controlled trial (RCT) as an adjunct to pharmacotherapy in the management of EOBD.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN59769322.
authors.affiliation: Institute of Neuroscience, Newcastle University, Henry Wellcome Building, The Medical School, Framlington Place, Newcastle Upon Tyne, NE2 4HH UK.
authors.forename: Joanne
authors.initials: J
authors.lastname: Neely
authors.affiliation: Division of Child and Adolescent Psychiatry, UCLA Semel Institute, David Geffen School of Medicine at UCLA, 760 Westwood Plaza Room 58-217, Los Angeles, CA 90024-1759 USA.
authors.forename: David
authors.initials: D
authors.lastname: Miklowitz
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle Upon Tyne, NE2 4AX UK.
authors.forename: Ann
authors.initials: A
authors.lastname: Le Couteur
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle Upon Tyne, NE2 4AX UK.
authors.forename: Vicky
authors.initials: V
authors.lastname: Ryan
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle Upon Tyne, NE2 4AX UK.
authors.forename: Luke
authors.initials: L
authors.lastname: Vale
authors.affiliation: Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle Upon Tyne, NE2 4AX UK.
authors.forename: Ruth
authors.initials: R
authors.lastname: McGovern
authors.affiliation: Institute of Neuroscience, Newcastle University, Henry Wellcome Building, The Medical School, Framlington Place, Newcastle Upon Tyne, NE2 4HH UK ; Complex Neurodevelopmental Disorders, Adolescent Bipolar Service, Walkergate Park Hospital, Benfield, Newcastle Upon Tyne, NE6 4QD UK.
authors.forename: Aditya
authors.initials: A
authors.lastname: Sharma
keywords: Adolescents; Bipolar disorder; Early onset; FAB; FFT-A UK; Psychological intervention; Trial; Young people