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

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Most cited references 19

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The Discovery of Grounded Theory

Barney G. Glaser, Anselm L. Strauss (1967)

Most writing on sociological method has been concerned with how accurate facts can be obtained and how theory can thereby be more rigorously tested. In The Discovery of Grounded Theory, Barney Glaser and Anselm Strauss address the equally Important enterprise of how the discovery of theory from data--systematically obtained and analyzed in social research--can be furthered. The discovery of theory from data--grounded theory--is a major task confronting sociology, for such a theory fits empirical situations, and is understandable to sociologists and laymen alike. Most important, it provides relevant predictions, explanations, interpretations, and applications.In Part I of the book, Generation Theory by Comparative Analysis, the authors present a strategy whereby sociologists can facilitate the discovery of grounded theory, both substantive and formal. This strategy involves the systematic choice and study of several comparison groups. In Part II, The Flexible Use of Data, the generation of theory from qualitative, especially documentary, and quantitative data Is considered. In Part III, Implications of Grounded Theory, Glaser and Strauss examine the credibility of grounded theory.The Discovery of Grounded Theory is directed toward improving social scientists' capacity for generating theory that will be relevant to their research. While aimed primarily at sociologists, it will be useful to anyone Interested In studying social phenomena--political, educational, economic, industrial-- especially If their studies are based on qualitative data.

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

Susanna Dodd, G Lancaster, Paula Williamson … (2004)

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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Evolving guidelines for publication of qualitative research studies in psychology and related fields.

D Rennie, C. Fischer, Timothy R. Elliott (1999)

We present a set of evolving guidelines for reviewing qualitative research, to serve four functions: to contribute to the process of legitimizing qualitative research; to ensure more appropriate and valid scientific reviews of qualitative manuscripts, theses, and dissertations; to encourage better quality control in qualitative research through better self- and other-monitoring; and to encourage further developments in approach and method. Building on a review of existing principles of good practice in qualitative research, we used an iterative process of revision and feedback from colleagues who engage in qualitative research, resulting in a set of seven guidelines common to both qualitative and quantitative research and seven guidelines especially pertinent to qualitative investigations in psychology and related social sciences. The Evolving Guidelines are subject to continuing revision and should not be used in a rigid manner, in order to avoid stifling creativity in this rapidly evolving, rich research tradition.

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Author and article information

Contributors

Joanne Neely: Joanne.neely@ncl.ac.uk

David Miklowitz: DMiklowitz@mednet.ucla.edu

Ann Le Couteur: A.S.Le-Couteur@ncl.ac.uk

Vicky Ryan: Vicky.Ryan@ncl.ac.uk

Luke Vale: Luke.Vale@ncl.ac.uk

Ruth McGovern: R.McGovern@ncl.ac.uk

Aditya Sharma: Aditya.Sharma@ncl.ac.uk

Journal

Journal ID (nlm-ta): Pilot Feasibility Stud

Journal ID (iso-abbrev): Pilot Feasibility Stud

Title: Pilot and Feasibility Studies

Publisher: BioMed Central (London )

ISSN (Electronic): 2055-5784

Publication date (Electronic): 7 December 2015

Publication date PMC-release: 7 December 2015

Publication date Collection: 2015

Volume: 1

Electronic Location Identifier: 43

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

Article

Publisher ID: 38

DOI: 10.1186/s40814-015-0038-7

PMC ID: 5153680

PubMed ID: 27965821

SO-VID: 1ba4f198-3c0f-444f-92db-2803ed8eb5cb

License:

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.

History

Date received : 23 June 2015

Date accepted : 17 November 2015

Custom metadata

Keywords: early onset,bipolar disorder,psychological intervention,trial,fft-a uk,young people,adolescents,fab

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Keywords: early onset, bipolar disorder, psychological intervention, trial, fft-a uk, young people, adolescents, fab

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

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Abstract

Background

Methods/Design

Discussion

Trial registration

Related collections

Special issue: Negotiating the Nation: Young people, national narratives and history education

Most cited references 19

The Discovery of Grounded Theory

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

Evolving guidelines for publication of qualitative research studies in psychology and related fields.

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Contributors

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