Condition category
Mental and Behavioural Disorders
Date applied
24/08/2015
Date assigned
08/09/2015
Last edited
24/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many young people experience mental, social and behavioural problems that can lead to negative consequences in later life, and the costs to society are high. It is proposed that providing a young person with an adult mentor (someone who is a positive force in their life) can help develop life skills, confidence and positive health which could avoid negative outcomes (e.g., poor attendance at school, engaging in risky behaviour). However, little research has been done to investigate whether mentoring programmes for young people can achieve some of these goals as there is a lack of well-designed studies within the United Kingdom. The Breakthrough mentoring scheme has been running in South Gloucestershire and other authorities for over 10 years. It is an activity-focused scheme in which a young person receives an adult mentor. There have been reports of positive outcomes for this scheme but it has not as yet been scientifically evaluated. This study aims to evaluate the Breakthrough mentoring programme and investigate whether providing students with a mentor can increase health, well-being and educational outcomes in these individuals.

Who can participate?
Students aged 11-16 years identified by school staff members as pupils that would benefit from Breakthrough mentoring scheme.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 receive a Breakthrough mentor (the intervention group) for the coming school year. Those in group 2 (the control group) do not receive a mentor .’ Irrespective of which group participants are allocated to, both continue to receive all the usual care and support provided by their school. All study participants are asked to complete a questionnaire at the start of the study (baseline), 6, 12 and 18 months later. This questionnaire asks about participants’ feelings, health, behaviour and well-being. We also run interviews with participants to explore, for example, what they thought about participating in the study, having or not having a mentor and completing the questionnaires. In addition, we interview or have small group discussions with other people involved in the process such as teachers and parents to explore their views of the study. Later, we look closely at both groups to see if there are any differences. However, as this is a feasibility study, sometimes called a ‘pilot,’ we would need to conduct a further larger study (a definitive randomised control trial) to check if these differences were related to mentoring.

What are the possible benefits and risks of participating?
Participants taking part in this research have the opportunity to participate in this research project and to tell us about their experiences of this. Each time participants complete a questionnaire (and an interview) they are provided with a gift voucher of £15. Regardless of whether participants are selected to receive a mentor or not, they will receive the same amount of overall money. Additionally, participants have a 1 in 2 (50%) chance of getting a mentor. This mentor will then be with the participant for a school year and will engage in activities that the participant would like to do. Participants can decide on the activities they want to do, when they want to meet with their mentor and on the goals they would like to set for themselves. There are no known risks in taking part in this study other than participants are required to spend approximately an hour of their time completing the questionnaire and taking part in an interview. Some participants as a result of completing this questionnaire and talking to the researchers may reveal very personal information that may have to be acted upon. Thus, whilst all information that participants provide is treated as confidential and no information about what they say is shared with others, the researcher may have to break confidentiality and inform another person if they believe a participant's health or safety is in danger. All study participants allocated to either the intervention or control group are made aware of the possible need to break confidentiality during the consent process at the start of the study.

Where is the study run from?
School of Community and Social Medicine, University of Bristol (UK)

When is the study starting and how long is it expected to run for?
June 2013 to September 2015

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
1. Dr Angela Beattie (public)
angela.beattie@bristol.ac.uk
2. Professor Rona Campbell (scientific)

Trial website

http://www.bristol.ac.uk/social-community-medicine/projects/breakthrough-mentoring/mentoring.html

Contact information

Type

Public

Primary contact

Dr Angela Beattie

ORCID ID

Contact details

University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
+44(0)117 9287351
angela.beattie@bristol.ac.uk

Type

Scientific

Additional contact

Prof Rona Campbell

ORCID ID

Contact details

University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1 dated 12/12/2013

Study information

Scientific title

Mentoring vulnerable and excluded adolescents to achieve better health and well-being: A feasibility study and pilot randomised control trial (RCT) of the Breakthrough Mentoring Scheme.

Acronym

Study hypothesis

This study will assess and evaluate the perceived helpfulness of the Breakthrough mentoring programme. It will also explore the feasibility and acceptability of individually randomising vulnerable young adolescents to intervention and control groups, collecting outcome data and estimating the parameters needed to design a definitive RCT.

Ethics approval

Faculty of Medicine and Dentistry Committee for Ethics (FCE), University of Bristol, 20/06/2013, ref: 121358

.

Study design

A feasibility study and pilot randomised control trial (RCT) of the Breakthrough Mentoring Scheme, compared with usual care including an embedded process and cost evaluation.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Other

Patient information sheet

http://www.bristol.ac.uk/social-community-medicine/projects/breakthrough-mentoring/young-people.html

Condition

Vulnerable young people (11-16 years) engaging in multiple risk behaviours deemed at risk of exclusion by school staff.

Intervention

Participants allocated to the intervention will receive Breakthrough mentoring for a school year in addition to any on-going support provided by the school.
Control group participants will continue to receive care as usual i.e., any on-going support provided by the school.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

This study will assess and evaluate the perceived helpfulness of the Breakthrough Mentoring Programme by conducting a qualitative process evaluation. It will also explore the feasibility of collecting data and estimating the parameters needed to design a definitive RCT.

Measured at baseline, 6, 12 & 18 month follow-ups.

Secondary outcome measures

1. Strengths and Difficulties questionnaire (SDQ)
2. Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)
3. Social Connectedness Scale- Revised (SCS-R)
4. Questions about risk behaviour (sexual health, alcohol and drug taking)

Assessed at the start of the study (baseline), 6, 12 and 18 months later

Overall trial start date

01/06/2013

Overall trial end date

30/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Students aged 11-16 years identified by school staff members as pupils that would benefit from Breakthrough mentoring scheme.

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

20

Participant exclusion criteria

Students will be excluded if they are either currently receiving or have received Breakthrough mentoring in the past.

Recruitment start date

10/09/2013

Recruitment end date

18/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Community and Social Medicine, University of Bristol
Canynge Hall 39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

c/o Dr Birgit Whitman
Head of Research Governance
Research and Enterprise Development
Senate House
Tyndall Avenue
Clifton
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

http://www.bristol.ac.uk/red/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. The findings will be published in peer reviewed practitioner journals and will be presented at national and one international conference. We will also present at local and public health research and practice conferences including the South West.
2. We will produce a short report on the research outcomes for the mentees (participants), parents, mentors, the local authority and participating school. We will make these available in a variety of easy-to-access paper and electronic formats and will also hold briefing meetings for these stakeholders.

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/02/2016: Internal review