Partially anonymised data e. Data validation is run on the data entered and data queries and corrections are sent to the researchers to clarify and correct anomalous data. Prior to the end of the study, quality control checks will be conducted, prior to the database being finalised. Trial monitoring will be performed by the University of Roehampton which will conduct regular audits and site visits to schools; and MAHSC-CTU which will conduct a mixture of remote monitoring of essential documentation and on-site monitoring of source data.
The site checks will aim to verify that the rights and well-being of participants are protected; verify accuracy, completion and validity of reported trial data from the source documents; and evaluate the conduct of the trial within the school with regard to compliance with the approved protocols. Names of participants on the consent forms personal data are stored separately from anonymised data in locked filing cabinets and only accessible by named personnel.
Statistical analysis will be carried out by the ETHOS principal statistician and economist according to a statistical analysis plan agreed in advance.
The principal statistician will be blind to the randomisation, with the exception of analysis of the WAI-S which is only completed by participants in the SBHC group. Allocation for all other measures will be coded as a non-identifiable variable in the clinical effectiveness analysis to minimise potential bias.
The principal economist cannot be blind to allocation due to the nature of the data being analysed e. The primary analysis will be based on the intention-to-treat principle. Per-protocol analysis will also be conducted. Baseline characteristics will be described by group and pooled using mean, standard deviation SD , minimum, maximum, median, and interquartile range.
Categorical variables will be described by frequency. Analyses will be performed using linear mixed-effects models LMMs including data from all randomised participants by intention to treat. Given the likely non-linear patterns of change and measures taken at discrete time points, analyses will be conducted at each time point, adjusted by baseline scores.
Standardised mean differences will be calculated using the LMM-estimated mean differences between groups at each time point after baseline, divided by the baseline SD.
Sensitivity analyses will be conducted to test for any moderating effects of support provided to participants to complete measures. Participants with and without missing data will be compared using baseline characteristics, including intervention allocation, to test for patterns of missing values and systematic biases. Multivariate imputation by chained equations will be used to compute questionnaire scores for participants with missing item responses. Secondary analysis will include modelling of the extent to which the relationship between intervention allocation and outcome is mediated by the BLRI variables, and testing for differences in the frequency of AEs by allocation.
Data will also be analysed within the treatment group to determine whether outcome is predicted by mid-point therapeutic alliance, while adjusting for all baseline variables. Costs and cost-effectiveness will be assessed for the follow-up point 24 weeks using a standard economic analysis framework, shown to be appropriate in an earlier trial [ 59 ].
To facilitate estimation of the full costs of SBHC, additional data will be collected from SBHC counsellors for example, on time spent travelling, liaising with professionals, or in supervision and from those organising the counsellor service. The amount of each service used by each young person will be multiplied by the appropriate unit cost and summed to arrive at a total support cost per young person for the baseline and follow-up 24 weeks time points.
Descriptive statistics frequencies, percentages, means, range, SD will be used to compare the support packages and costs at each time point for each group. Service and support costs will be identified by funder, including those supports and services provided and funded by the school. Care will be taken to identify any systematic cost differences between locations schools as the local array of services may differ, leading to variations in access and, therefore, use.
In the event of the SBHC group having both higher costs and generating improved outcomes, the current approach is to estimate cost-effectiveness acceptability curves CEACs. The net monetary benefit for the outcome measures will be calculated and the proportion of bootstrapped estimates of the group difference favouring SBHC will be plotted with corresponding values of willingness to pay. An adverse event AE is defined as any negative psychological, emotional or behavioural occurrence, or sustained deterioration in a research participant.
In the current trial, we have included arrest by police; running away from home; excluded from family home; school exclusion; significant decrease in school attendance; significant deterioration in behaviour, including threatening violence, exhibiting violent behaviour or serious injury to another person, exposure to violence or abuse; significant increase in emotional difficulties; self-harm if not a presenting issue , or escalating self-harm when it is a presenting issue ; a complaint made against the counsellor, or an issue with the counsellor, resulting in discontinuation of counselling; suicidal ideation; suicidal intent; hospitalisation due to drugs or alcohol, or for psychiatric reasons; and death, including suicide.
An Adverse Events Reporting Form is used by all individuals in contact with participants, who are trained to recognise and respond, in an ethical and timely way, to risk and any issues relating to safeguarding. However, in practice the CI relies on all research staff, counsellors, supervisors and school staff to ensure that AEs are identified and addressed in an appropriate and timely manner. Thus, safety is a shared responsibility. Individuals completing the form are asked to consider whether the AE is serious, defined as any AE which is life threatening or results in death, and whether it may be a result of participating in the trial.
The severity of each AE is also assessed, according to its intensity, duration and the degree of impairment to the young person or, when relevant, another person such as in case of risk to others. In the case of SAEs, or those deemed related to participating in the trial, expedited reporting procedures are followed, which includes a reporting timeframe of one week from receipt of the AE Reporting Form.
The aim is to ensure that the trial explores issues of relevance to young people, and minimises participant attrition. Representatives from both panels have been invited to join the Trial Steering Committee see below.
Panel members include young people who have received training from the NCB Research Centre in a range of research skills e. We have aimed to involve these panel members at all stages of the study where possible, and look to include them in our dissemination activities where we know that peer feedback is a highly effective way of ensuring that research findings reach the intended audience. The role of the TSC is to monitor the scientific integrity of the trial, the scientific validity of the trial protocol, assessment of the trial quality and conduct as well as for the scientific quality of the final trial report.
Decisions about the continuation or termination of the trial or substantial amendments to the protocol are the responsibility of the TSC. A TMG has been established and includes those individuals responsible for the day-to-day management of the trial including the CI, project manager, principal statistician and economist, and all co-researchers. Notwithstanding the legal obligations of the lead organisation University of Roehampton and the CI, the TMG has operational responsibility for the conduct of the trial including monitoring overall progress to ensure that the protocol is adhered to, and taking appropriate action to safeguard the participants and the quality of the trial if necessary.
Evidence of the effectiveness of psychotherapeutic interventions with children and adolescents comes mainly from trials of CBT for the treatment of anxiety and depression.
As many young people referred to school counselling services are more likely to be experiencing emotional distress as a result of a range of life difficulties, rather than a specific clinical disorder, there is a need for school-based interventions that address these needs. SBHC presents one such potential intervention, and the results from four pilot trials provide preliminary evidence of clinical effectiveness.
Determining the clinical and cost-effectiveness of SBHC is important 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. Conducting the current trial in a school real-world setting is a pragmatic approach to assessing the effectiveness of SBHC compared to PCAU, with the added advantage of being able to evaluate the intervention in a way that mirrors routine practice.
A further advantage of conducting the current trial in a school setting pertains to school culture and day-to-day structures e. There are also significant challenges to conducting the current trial within a school context. Necessary protocols for ethical research practice can present a burden to included schools, which are not familiar with the research-related administration involved in running a trial of this size.
These particular challenges have necessitated training provision and regular debriefing in the research aspects of the trial, with schools; and the nature and realities of school life to our researchers, as well as developing and maintaining strong working relationship between sub-teams. In addition, a considerable challenge has included developing a protocol for monitoring and reporting AEs in counselling. The academic literature regarding AE monitoring in RCTs generally relates to trials of pharmacological interventions and there is scant academic literature in the counselling and psychotherapy fields.
This has require us to utilise a process of adopting and adapting a model of monitoring and reporting more commonly applied in pharmacological studies, as well as drawing on the clinical expertise within the core research team to inform protocol development. We view our current approach as iterative, and aim towards being able to share an established, more definitive, set of protocols with the counselling research community on trial completion.
The results of this trial will contribute significantly to the evidence base for SBHC and to the wider field of adolescent mental health interventions. Our data also has the potential to inform the development of national guidelines for mental health support for schools and make a direct contribution at a policy level, by providing up-to-date and reliable information about the utility of school counselling. A trial that is powered to detect clinically meaningful differences also provides an opportunity to develop an understanding of the process of change in SBHC, and to trial the newly established competency framework for humanistic counselling with children and young people [ 30 ].
Furthermore, the research will be used to develop and test a manual for the effective implementation of SBHC by counsellors and psychotherapists. The study commenced recruitment in September and recruitment due for completion in February Mental health of children and young people in Great Britain.
Office for National Statistics. Google Scholar. Accessed 9 Sep Relative impact of young adult personality disorders on subsequent quality of life: findings of a community-based longitudinal study.
J Personal Disord. Article Google Scholar. Show me the child at seven: the consequences of conduct problems in childhood for psychosocial functioning in adulthood.
J Child Psychol Psychiatry. Article PubMed Google Scholar. The Maudsley long-term follow-up of child and adolescent depression. Eur Child Adolesc Psychiatry. Financial cost of social exclusion: follow up study of antisocial children into adulthood. Innocenti Report card 9. Hawton K, Suicide JA. World Health Organization. The world health report. Geneva: WHO Press; Three years on: survey of the development and emotional well-being of children and young people.
Newport, UK: Office for National. Statistics; Gutman LM, Vorhaus L. The impact of pupil behaviour and wellbeing on educational outcomes. London: Department for. Education; Br Educ Res J.
Continuity and change of psychopathology from childhood into adulthood: a year follow-up study. Prior juvenile diagnoses in adults with mental disorder: developmental follow-back of a prospective-longitudinal cohort.
Arch Gen Psychiatry. Mental health promotion and mental illness prevention: The economic case. London: Department of Health; Kazdin AE. Psychotherapy for children and adolescents.
In: Lambert MJ, editor. It offered a new perspective on how human beings experienced the world and those in it, based on their perception of the world around them. It put individual conscious perception at the heart of the human experience. It provided an expanded horizon of methods of inquiry in the study of human behaviour. It focused on the personal perception of themselves and others.
One of the key elements of the approach is that human beings are not solely the product of their environment; they are internally directed to fulfil their potential , sometimes referred to as ' self-actualisation ' Maslow It changed the way psychotherapists approached the treatment of those who were having emotional difficulties.
They relied less on analysis and directing the client. Although it offers no ultimate answers, existential therapy optimistically embraces human potential while realistically acknowledging human limitations.
It focuses on the positive potential for good and growth that is inherent in the human condition. Instead of scientifically and objectively evaluating and analysing existence, existential therapy advocates subjective interpretation by describing and understanding things in order to grasp their essence. Imagination and emotion are likewise explored. Existential therapy also introduces the themes of free will, choice, personal and social responsibility, and courage in facing rather than escaping the anxieties of existence.
In specific terms, existential therapy helps the client understand and find freedom or relief from excessive anxiety, alienation, apathy, shame, addiction, despair, depression, guilt, anger, rage, embitterment, violence, madness or psychosis, purposelessness, and nihilism.
Nihilism refers to the total destructiveness which springs from the belief that all values are baseless. It counters these negative conditions by promoting meaningful, life-enhancing experiences such as love, caring, relationships, commitment, courage, will, power, self-actualisation, authenticity, acceptance, transcendence, spirituality, presence, and awe. Gestalt Therapy focuses on helping a person fully experience her present situation rather than going back in time to talk about past events.
The therapist does not interpret the experience for the client. Instead, both of them work together to help the client understand herself.
Gestalt therapy aims to help the client figure out her unique configuration; in short, gain self-awareness so that unresolved interpersonal issues can surface and immediate needs can be met.
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