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A feasibility study of a Family Focused Treatment for Adolescents with Bipolar Disorder—the FAB study

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      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/Design

      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.

      Discussion

      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.

      Trial registration

      Current Controlled Trials ISRCTN59769322

      Related collections

      Most cited references 23

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      Qualitative research in health care: Analysing qualitative data

       C Pope (2000)
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        THE McMASTER FAMILY ASSESSMENT DEVICE*

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          Design and analysis of pilot studies: recommendations for good practice.

          Pilot studies play an important role in health research, but they can be misused, mistreated and misrepresented. In this paper we focus on pilot studies that are used specifically to plan a randomized controlled trial (RCT). Citing examples from the literature, we provide a methodological framework in which to work, and discuss reasons why a pilot study might be undertaken. A well-conducted pilot study, giving a clear list of aims and objectives within a formal framework will encourage methodological rigour, ensure that the work is scientifically valid and publishable, and will lead to higher quality RCTs. It will also safeguard against pilot studies being conducted simply because of small numbers of available patients.
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            Author and article information

            Affiliations
            [1]Institute of Neuroscience, Newcastle University, Henry Wellcome Building, The Medical School, Framlington Place, Newcastle Upon Tyne, NE2 4HH UK
            [2]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
            [3]Institute of Health & Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle Upon Tyne, NE2 4AX UK
            [4]Complex Neurodevelopmental Disorders, Adolescent Bipolar Service, Walkergate Park Hospital, Benfield, Newcastle Upon Tyne, NE6 4QD UK
            Contributors
            Joanne.neely@ncl.ac.uk
            DMiklowitz@mednet.ucla.edu
            A.S.Le-Couteur@ncl.ac.uk
            Vicky.Ryan@ncl.ac.uk
            Luke.Vale@ncl.ac.uk
            R.McGovern@ncl.ac.uk
            Aditya.Sharma@ncl.ac.uk
            Journal
            Pilot Feasibility Stud
            Pilot Feasibility Stud
            Pilot and Feasibility Studies
            BioMed Central (London)
            2055-5784
            7 December 2015
            7 December 2015
            2015
            : 1
            27965821
            5153680
            38
            10.1186/s40814-015-0038-7
            © Neely et al. 2015

            Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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