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      Effectiveness and cost-effectiveness of humanistic counselling in schools for young people with emotional distress (ETHOS): study protocol for a randomised controlled trial

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          Abstract

          Background

          One in ten children in Britain have been identified as experiencing a diagnosable mental health disorder. School-based humanistic counselling (SBHC) may help young people identify, address, and overcome psychological distress. Data from four pilot trials suggest that SBHC may be clinically effective. However, a fully powered randomised controlled trial (RCT) is needed to provide a robust test of its effectiveness, to assess its cost-effectiveness, and to determine the process of change.

          Methods/design

          The Effectiveness and Cost-effectiveness Trial of Humanistic Counselling in Schools (ETHOS) is a two-arm, parallel-group RCT comparing the clinical and cost-effectiveness of SBHC with Pastoral Care as Usual (PCAU) in school settings. Eligibility criteria for young people include being between 13 and 16 years of age and experiencing moderate to severe levels of emotional distress. Participants are randomised to receive either SBHC or PCAU. SBHC is delivered in up to 10 weekly, individual sessions in their school with a qualified, experienced counsellor who has also received training using a clinical practice manual. Adherence to the SBHC model is assessed by a sub-team of auditors and in clinical supervision. PCAU consists of the schools’ pre-existing systems for supporting the emotional health and well-being of students. The primary outcomes are psychological distress measured using the Young Person’s Clinical Outcomes in Routine Evaluation (YP-CORE) and costs evaluated using the Client Service Receipt Inventory (CSRI). Secondary outcomes include psychological difficulties, levels of depression, anxiety and self-esteem, well-being, school engagement, educational outcomes and achievement of personal goals. Qualitative interviews with participants, parents and school staff will look to identify the mechanisms of change in SBHC. Researchers administering the measures are blind to allocation. The trial requires n = 306 participants ( n = 153 in each group), with 90% power to detect a standardised mean difference (SMD) of 0.5. An intention-to-treat analysis will be undertaken.

          Discussion

          This RCT is powered to detect clinically meaningful differences, and will make a major contribution to the evidence base for mental health provision for adolescents. It will have implications for all stakeholders, including policy-makers, statutory advisory bodies for child welfare, head teachers, children and young people practitioners, child welfare and parenting organisations, and young people.

          Trial registration

          Controlled Trials International Standard Randomised Controlled Trial Number (ISRCTN) Registry, ID: ISRCTN10460622. Registered on 11 May 2016.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-018-2538-2) contains supplementary material, which is available to authorized users.

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          Most cited references56

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          Using thematic analysis in psychology

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            Society and the Adolescent Self-Image

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              The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation

              Background There is increasing international interest in the concept of mental well-being and its contribution to all aspects of human life. Demand for instruments to monitor mental well-being at a population level and evaluate mental health promotion initiatives is growing. This article describes the development and validation of a new scale, comprised only of positively worded items relating to different aspects of positive mental health: the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Methods WEMWBS was developed by an expert panel drawing on current academic literature, qualitative research with focus groups, and psychometric testing of an existing scale. It was validated on a student and representative population sample. Content validity was assessed by reviewing the frequency of complete responses and the distribution of responses to each item. Confirmatory factor analysis was used to test the hypothesis that the scale measured a single construct. Internal consistency was assessed using Cronbach's alpha. Criterion validity was explored in terms of correlations between WEMWBS and other scales and by testing whether the scale discriminated between population groups in line with pre-specified hypotheses. Test-retest reliability was assessed at one week using intra-class correlation coefficients. Susceptibility to bias was measured using the Balanced Inventory of Desired Responding. Results WEMWBS showed good content validity. Confirmatory factor analysis supported the single factor hypothesis. A Cronbach's alpha score of 0.89 (student sample) and 0.91 (population sample) suggests some item redundancy in the scale. WEMWBS showed high correlations with other mental health and well-being scales and lower correlations with scales measuring overall health. Its distribution was near normal and the scale did not show ceiling effects in a population sample. It discriminated between population groups in a way that is largely consistent with the results of other population surveys. Test-retest reliability at one week was high (0.83). Social desirability bias was lower or similar to that of other comparable scales. Conclusion WEMWBS is a measure of mental well-being focusing entirely on positive aspects of mental health. As a short and psychometrically robust scale, with no ceiling effects in a population sample, it offers promise as a tool for monitoring mental well-being at a population level. Whilst WEMWBS should appeal to those evaluating mental health promotion initiatives, it is important that the scale's sensitivity to change is established before it is recommended in this context.
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                Author and article information

                Contributors
                megan.stafford@roehampton.ac.uk
                mick.cooper@roehampton.ac.uk
                m.barkham@sheffield.ac.uk
                J.Beecham@lse.ac.uk
                peter.bower@manchester.ac.uk
                karen.cromarty@roehampton.ac.uk
                a.fugard@bbk.ac.uk
                Charlie.Jackson@bacp.co.uk
                Peter.Pearce@metanoia.ac.uk
                Bekah.Ryder@housing.org.uk
                cathy.street1@btinternet.com
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                9 March 2018
                9 March 2018
                2018
                : 19
                : 175
                Affiliations
                [1 ]ISNI 0000 0001 0468 7274, GRID grid.35349.38, Department of Psychology, , University of Roehampton, Whitelands College, ; Holybourne Avenue, London, SW15 4JD UK
                [2 ]ISNI 0000 0004 1936 9262, GRID grid.11835.3e, Centre for Psychological Services Research, Department of Psychology, , University of Sheffield, ; Sheffield, S10 2TN UK
                [3 ]ISNI 0000 0001 0789 5319, GRID grid.13063.37, Personal Social Services Research Unit (PSSRU) at the London School of Economics, ; Houghton St, London, WC2A 2AE UK
                [4 ]ISNI 0000 0001 2232 2818, GRID grid.9759.2, PSSRU at the Faculty of Social Sciences, Cornwallis North East, , University of Kent, ; Canterbury, Kent CT2 7NF UK
                [5 ]ISNI 0000000121662407, GRID grid.5379.8, NIHR School for Primary Care Research, Division of Population Health, Health Services Research and Primary Care, Manchester Academic Health Science Centre, , University of Manchester, ; Williamson Building, Oxford Road, Manchester, M13 9PL UK
                [6 ]Karen Cromarty Consultancy, 4 Bamburgh Road, Durham, DH1 5NW UK
                [7 ]ISNI 0000000121901201, GRID grid.83440.3b, Research Department of Clinical, Educational and Health Psychology, , University College London, ; Gower Street, London, WC1E 6BT UK
                [8 ]ISNI 0000 0001 2324 0507, GRID grid.88379.3d, Department of Psychosocial Studies, , Birkbeck, University of London, ; 30 Russell Square, London, WC1B 5DT UK
                [9 ]BACP House, 15 St John’s Business Park, Lutterworth, Leicester, LE17 4HB UK
                [10 ]Applied Social and Organisational Sciences, Metanoia Institute, 13 Gunnersbury Ave, Ealing, London, W5 3XD UK
                [11 ]Formerly the National Children’s Bureau, Research and Policy, 8 Wakley Street, London, EC1V 7QE UK
                Author information
                http://orcid.org/0000-0003-1339-2966
                Article
                2538
                10.1186/s13063-018-2538-2
                5845203
                29523206
                4b7e5289-175d-411f-9a98-ff899a2a33bc
                © The Author(s). 2018

                Open AccessThis 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
                : 29 November 2017
                : 9 February 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000269, Economic and Social Research Council;
                Award ID: ES/M011933/1
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Medicine
                school-based humanistic counselling,randomised controlled trial,young people,psychological distress,cost-effectiveness

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