Condition category
Mental and Behavioural Disorders
Date applied
11/05/2016
Date assigned
16/05/2016
Last edited
04/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
According to a report published by the World Health Organization in 2006, levels of mental health problems in children and young people are increasing. In 2010, UNICEF also reported that Britain is falling behind in promoting well-being in children. A study conducted by the Princes Trust in 2012 reported that 30% of young people aged between 16 and 25 reported that they always or often felt ‘down’ or ‘depressed’, and 21% felt that they did not receive the support they needed from school. Behavioral and emotional difficulties have been shown to negatively affect school attendance and educational achievement, which in the long-term can have a detrimental effect on employment and health. In several small sized studies, school-based humanistic counselling (SBHC) has been found to have good short term potential in terms of reducing psychological distress at a relatively low cost, however larger studies are needed to evaluate its true effectiveness. SBHC is a widely used counselling program which focuses on self-development, growth and responsibilities. The aim of this current study is to investigate the effectiveness of SBHC on psychological distress, and a range of other measures such as self-esteem, symptoms of anxiety and depression, school engagement and other educational indicators; as well as how cost-effective it is to deliver, in young people.

Who can participate?
Young people aged between 13 and 16 who attend a participating school and are experiencing moderate to severe levels of distress.

What does the study involve?
Participants are randomly allocated to one of two groups. Young people in the first group receive up to 10 sessions of humanistic counselling with a qualified school counsellor. This is based on the British Association for Counselling and Psychotherapy’s competencies framework for 11-18 year-olds. Young people in the second group receive their school’s usual pastoral care. After six-nine months, these participants are offered the opportunity to have up to 10 sessions of humanistic counselling with a qualified school counsellor. All young people taking part in the study are asked to complete some questionnaires at the beginning of their involvement, then 6, 12 and 24 weeks later in order to assess their mental health and educational attainment. Additionally some young people are also asked to take part in an interview with a researcher which aims to explore their experiences of counselling in more depth.

What are the possible benefits and risks of participating?
Participants benefit from the opportunity to access counselling, to contribute to the development of the researcher's understanding of counselling, and may also learn more about themselves. The majority of young people find that counselling is helpful to them. Additionally, participants will have the opportunity to provide their opinions and ideas about what is helpful to them when they are experiencing distress. Counselling sometimes involves talking about painful and difficult feelings. In addition, the questionnaires or researchers' questions may touch on some sensitive issues, so there is a small chance that this might led to upset or worry. The questionnaires may also feel boring or irritating to fill out.

Where is the study run from?
The study is run from University of Roehampton and takes place in 19 secondary schools in London, England (UK)

When is the study starting and how long is it expected to run for?
April 2016 to March 2019

Who is funding the study?
Economic and Social Research Council (UK)

Who is the main contact?
1. Miss Megan Stafford (public)
megan.stafford@roehampton.ac.uk
2. Professor Mick Cooper (scientific)

Trial website

http://www.roehampton.ac.uk/ETHOS/

Contact information

Type

Public

Primary contact

Miss Megan Stafford

ORCID ID

http://orcid.org/0000-0003-1339-2966

Contact details

Department of Psychology
University of Roehampton
Whiteland's College
Holybourne Avenue
London
SW15 4JD
United Kingdom
+44 (0)20 8392 3741
megan.stafford@roehampton.ac.uk

Type

Scientific

Additional contact

Prof Mick Cooper

ORCID ID

http://orcid.org/0000-0003-1492-2260

Contact details

Department of Psychology
University of Roehampton
Whiteland's College
Holybourne Avenue
London
SW15 4JD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N

Study information

Scientific title

Effectiveness and cost effectiveness Trial of Humanistic cOunselling in Schools

Acronym

ETHOS

Study hypothesis

The aim of this study is to investigate whether:
1. School-based humanistic counselling (SBHC) is effective in reducing psychological distress in young people compared with pastoral care as usual (PCAU)
2. SBHC is a cost-effective way of reducing psychological distress in young people compared with pastoral care as usual

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

Condition

Psychological distress

Intervention

Eligible participants are randomly allocated to the school-based humanistic counselling (SBHC) group, or the pastoral care as usual (PCAU) group.

SBHC group: Participants take part in up to 10 weekly sessions lasting for approximately 45 minutes each of school-based humanistic counselling (SBHC) for psychologically distressed young people (aged 13-16). The intervention will be based on competences for humanistic counselling with young people aged 11-18 years (Hill, Roth & Cooper, 2014).

PCAU group: The schools’ pre-existing systems for supporting the emotional health and well-being of students is in place for participants in this group. This will consist of established interventions which may involve a personal tutor, or a school inclusion lead, meeting regularly with the young person to speak about their difficulties.

Participants in both groups are followed up at 6 weeks, 12 weeks and 24 weeks. A sample of participants are also asked to participate in an interview to explore their experiences of counselling in more depth.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Primary outcome measures as of 12/07/2016:
1. Psychological distress is measured using the YP-CORE at baseline, 6 weeks, 12 weeks and 24 weeks
2. Change in use of services and supports and costs from baseline to 24 weeks is measured using
the Client Service Receipt Inventory (CSRI)

Original primary outcome measure:
Psychological Distress is measured using the YP-CORE at baseline, weekly throughout the intervention period (including at 6 weeks from baseline), 12 weeks and 6 months.

Secondary outcome measures

Secondary outcome measures as of 12/07/2016:
1. Psychological difficulties is measured using the Strengths and Difficulties Questionnaire (SDQ) at baseline, 6 weeks, 12 weeks and 24 weeks
2. Symptoms of anxiety and depression are measured using the Revised Children's Anxiety and Depression Scale (RCADS) at baseline, 6 weeks, 12 weeks and 24 weeks
3. Self-esteem is measured using the Rosenberg Self-esteem Scale (RSES) at baseline, 6 weeks, 12 weeks and 24 weeks
4. Behavioural engagement at school is measured using the Student Engagement Scale - Behavioral Engagement subscale (SES-BE) at baseline, 6 weeks, 12 weeks and 24 weeks
5. Well-being is measured using the Warwick- Edinburgh Mental Well-being Scale (WEMWBS) at baseline, 6 weeks, 12 weeks and 24 weeks
6. Achievement of personal goals are measured using the Goal Based Outcomes Record Sheet (GBORS) at baseline, 6 weeks, 12 weeks and 24 weeks
7 Service user satisfaction is measured using the Experience of Service Questionnaire (CHI-ESQ) at 12 weeks
8. Service user satisfaction is also measured using the Outcome Rating Scale (ORS) weekly throughout the intervention period

Original secondary outcome measures:
1. Strengths and Difficulties Questionnaire (SDQ) at baseline, 6 weeks, 12 weeks and 6 months
2. Goal-based Outcome Measure (GBOM) at baseline, 6 weeks, 12 weeks and 6 months
3. Revised Children's Anxiety and Depression Scale (RCADS) at baseline, 6 weeks, 12 weeks and 6 months
4. Culture Free Self-Esteem Inventory (CFSEI - 3) at baseline, 6 weeks, 12 weeks and 6 months
5. Resilience Scale (READ) at baseline, 6 weeks, 12 weeks and 6 months
6. Change in use of services and supports and costs from baseline to 6 months is measured using the Client Service Receipt Inventory (CSRI)
7. Educational engagement is measured by rates of attendance, exclusion, detentions and disciplinary proceedings at 6 months
8. Impact of the counselling on young people and school is assessed through in-depth interviews with a sample of teachers, pastoral care teams and parents/carers at 6 months

Overall trial start date

01/04/2016

Overall trial end date

31/03/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria as of 12/07/2016:
In order to be eligible to take part in the ETHOS study, the young person must meet all of the following criteria at the point of assessment:
1. Aged between 13 and 16 years of age at the time of assessment
2. Be experiencing moderate to severe levels of psychological distress as assessed by a score of 5 or more on the Strengths and Difficulties Questionnaire (SDQ) Emotional Symptoms Scale
3. Able to speak and read English (with a minimum reading age of 13 years)
4. Want to participate in counselling, or want to undertake counselling, or want to see a counsellor
5. Not currently in receipt of counselling or any other therapeutic intervention that may be impeded through participation in the trial
6. Have a school attendance record of at least 85% as assessed by the school

Original inclusion criteria:
1. Aged between 13 and 16 years of age at the time of assessment
2. Be experiencing moderate to severe levels of psychological distress as assessed by a score of >5 on the Strengths and Difficulties Questionnaire (SDQ) Emotional Symptoms Scale
3. Able to speak and read English
4. Not currently in receipt of counselling, or any other psychological intervention
5. Have a school attendance record of at least 85% as assessed by the school

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

306

Participant exclusion criteria

Exclusion criteria as of 12/07/2016:
1. Considered by the researcher, as unable to provide informed consent (not ‘Gillick competent’)
2. The parent/carer of the young person has not provided their consent for the young person to take part in the study
3. Assessed by the researcher, or a teacher, to be at risk of serious harm to self or others at the time of assessment
4. Planning to leave the school within the academic year
5. Unwilling to complete all assessments
6. Unwilling to allow sessions to be audio recorded for the purposes of auditing

Original exclusion criteria:
1. Considered by the researcher, as unable to provide informed consent
2. The parent/carer of the young person has not provided their consent for the young person to take part in the study
3. Assessed by the researcher, or a teacher, to be at serious risk to self or others at the time of assessment
4. Planning to leave the school within the academic year
5. Unwilling to allow sessions to be audio recorded for the purposes of auditing

Recruitment start date

05/09/2016

Recruitment end date

30/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Roehampton
Department of Psychology Whiteland's College Holybourne Avenue
London
SW15 4JD
United Kingdom

Sponsor information

Organisation

University of Roehampton (UK)

Sponsor details

Whiteland's College
Holybourne Avenue
London
SW15 4JD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Economic and Social Research Council

Alternative name(s)

ESRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The main trial publication will report the effectiveness and cost-effectiveness of SBHC.

Intention to publish date

31/10/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

04/08/2016: Internal review 12/07/2016: The publication and dissemination plan and availability of participant level data have been added. In addition, the target number of participants has been updated from 324 to 306, and the outcome measures, inclusion criteria and exclusion criteria have been updated.