Condition category
Mental and Behavioural Disorders
Date applied
24/10/2013
Date assigned
19/11/2013
Last edited
20/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Young people in the UK are experiencing increasing levels of psychological distress and counselling services have been established in many secondary schools to help them deal with this. Young people tend to be very positive about counselling, but the availability of services varies widely, there is little consistency in the type of therapy offered, and evidence for its effectiveness is limited. This study examines the effectiveness of a standardised school-based counselling intervention - school-based person-centred counselling (SBPCC) - which has been developed on the basis of the best available evidence.

Who can participate?
Young people in years 7, 8, 9, 10 or 12 experiencing moderate or abnormally high levels of emotional distress.

What does the study involve?
The participants will be randomly allocated to either receive counselling (SBPCC) immediately or will be put on a waiting list, to be offered counselling in 9 months. After 9 months, we will look at whether those young people who received counselling are experiencing less psychological distress than those who did not. We will also look at whether the benefits of providing a counselling service justify the costs.

What are the possible benefits and risks of participating?
If SBPCC turns out to be helpful and cost-effective we may be able to make a major contribution to addressing psychological health problems in UK youth. Because of the sensitive issues being
addressed in this study, we will not include any young people at risk of harm, but refer them to specialist support. We will ensure the highest levels of confidentiality for participants. The study team has extensive experience of work and research with young people and mental health.

Where is the study run from?
1. Saint Gabriel’s College (UK)
2. Shooters Hill Post Sixteen (UK)
3. Sydenham Girls School (UK)

When is the study starting and how long is it expected to run for?
The study started in January 2013 and will run until January 2014.

Who is funding the study?
1. Metanoia Institute (UK)
2. British Association for Counselling and Psychotherapy (BACP) (UK)

Who is the main contact?
Mr Peter Pearce
Peter.pearce@metanoia.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Peter Pearce

ORCID ID

http://orcid.org/0000-0003-0864-0021

Contact details

Metanoia Institute
13 North Common Road
Ealing
London
W5 2QB
United Kingdom
+44 (0)20 8579 2505
Peter.pearce@metanoia.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MIPC1

Study information

Scientific title

A pragmatic randomised controlled trial of person-centred, school-based counselling

Acronym

ALIGN

Study hypothesis

For children and young people experiencing emotional distress, weekly counselling will be more effective than waiting list conditions after one school term.

Ethics approval

Metanoia Research Ethics Committee, 07/01/2013

Study design

Pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Moderate to abnormal levels of psychological distress

Intervention

Following baseline assessment eligible participants will be randomised to either counselling now or to a waiting list, to be offered counselling in 9 months. A blocked, permuted, randomisation procedure is conducted by the assessor via text.

School-based person-centred counselling (SBPCC) delivered in up to 12 weekly sessions of approximately 45 minutes each. The intervention will be based on competencies for person-centred and humanistic psychological therapy. Adherence to these competences will be audited using the PCEPS Scale, a validated adherence measure for person centred and experiential therapies.

The total duration of treatment was 12 weeks (mapping on to one school term) with 3 follow-up assessments at 6 weeks (mid-point assessment), 12 weeks (end-point assessment), at 6 months (follow-up assessment) and 9 months (follow-up assessment).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Psychological distress is measured using the Young persons CORE (YP-CORE) at baseline, 6 and 9 months

Secondary outcome measures

1. The Strengths and Difficulties Questionnaire (SDQ), Goal Based Outcome Measure (GBOM), Rosenbergs Self-Esteem Inventory (RSEI) at baseline, 6 weeks, 3, 6 and 9 months
2. Helpful/unhelpful aspects of counselling will be assessed by qualitative interviews (adapted change Interview) at baseline, 6 weeks, 3, 6 and 9 months
3. The impact of counselling on young people and the school will be assessed through in-depth interviews with a sample of teaching staff at 9 months
4. Behavioural impact will be assessed through rates of attendance, exclusion, detentions and disciplinary proceedings and educational outcomes through achievement and attainment projections at 9 months
5. Cost analysis will be assessed by an adapted Client Service Receipt Inventory (CSRI) completed at baseline, 6 weeks and 3, 6 and 9 months. Public sector support package costs will be derived from CSRI data on use of services for which unit costs will be sought from publicly available sources. Cost and outcome data will be compared using the YP-CORE and GBOM.

Overall trial start date

03/01/2013

Overall trial end date

13/01/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Young people will be in years 7,8,9,10 or 12
2. Experiencing moderate or abnormally high levels of emotional distress, as indicated by a score of 5 or above on the Strengths and Difficulties Questionnaire (SDQ) emotional symptoms subscale at assessment
3. Motivated to attend counselling, as indicated during assessment
4. Capable of consenting to participate in research, as indicated by the pastoral care team prior to assessment
5. Good attendance record, greater than 85% attendance at school as indicated by the pastoral care team prior to assessment.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. At risk of significant harm to self or other, as indicated by the pastoral care team
2. Involved with other child and young people's mental health agencies, as indicated by the pastoral care team and/ or the young person at assessment
3. Planning/likely to move school during the period of the study, as indicated by the pastoral care team and/ or young person at assessment
4. In year 11 or 13

Recruitment start date

03/01/2013

Recruitment end date

13/01/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Saint Gabriel’s College
Cormont Road
London
SW9 6UL
United Kingdom

Trial participating centre

Shooters Hill Post Sixteen
Red Lion Lane
London
SE18 4LD
United Kingdom

Trial participating centre

Sydenham Girls School
Dartmouth Road
London
SE26 4RD
United Kingdom

Sponsor information

Organisation

Metanoia Institute

Sponsor details

13 North Common Road
Ealing
London
W5 2QB
United Kingdom
+44 (0)20 8579 2505
Peter.pearce@metanoia.ac.uk

Sponsor type

University/education

Website

http://www.metanoia.ac.uk

Funders

Funder type

University/education

Funder name

Metanoia Institute (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

British Association for Counselling and Psychotherapy (BACP) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

IPD Sharing plan:
This data will not be made available due to data protection stated in the ethics application and in meetings with each school that data would only be stored at Metanoia Institute in a secure, locked, filing room and on a secure encrypted hard drive.

Intention to publish date

31/07/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 results in http://www.ncbi.nlm.nih.gov/pubmed/27470500

Publication citations

Additional files

Editorial Notes

20/09/2016: Results publication added. In addition, the names of the trial participating centres have been added as well as the IPD sharing plan 13/09/2016: No publications found in PubMed, verifying study status with principal investigator.