Condition category
Mental and Behavioural Disorders
Date applied
07/12/2016
Date assigned
18/01/2017
Last edited
18/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The transition to secondary school is an important time for children, and adjusting to secondary school is important for children’s social and emotional wellbeing. The best ways to support children during this important time are unknown however. This study is investigating whether a program that has been developed to improve psychological and social wellbeing and resilience (called ‘Team of Life’) will better support children when added to the supports schools currently have in place. In order to test the effectiveness of this program, it is important to find conduct a small study to find out if enough participants can be recruited and if the study methods will work. The aim of this study is to find out if conducting a large study looking at whether children receiving the Team of Life program in the first term of secondary school do better than those who have the usual pastoral care provided by schools is feasible.

Who can participate?
Year 7 pupils attending participating schools deemed to be vulnerable in the transition from primary into secondary school.

What does the study involve?
Participating schools are randomly allocated to one of two groups. Schools in the first group continue deliver supportive transitional support as usual (TAU). In the second group, school staff in the are trained to deliver the TOL program alongside pupil peer mentors and supervised by a CAMHS (child and adolescent mental health service) health professional. Pupils participating in the study report on their own wellbeing and emotional and behavioural difficulties via questionnaires at the start of the study and at the end of the program. Parents and teachers also complete similar reports about the pupil. Teachers are asked to report on the pupil’s engagement in school and peer relations at these time points. Interviews and focus groups are also conducted at the end of the study to assess pupil and peer mentor experiences of taking part in the TOL group.

What are the possible benefits and risks of participating?
It is not currently known whether the Team of Life programme will be beneficial, however in some small pilot studies children have reported that they enjoyed the programme and found it helpful. There are no notable risks involved with particiating

Where is the study run from?
The study is run by University of Liverpool and Cheshire and Wirral Partnership NHS Foundation Trust and takes place in eight secondary schools in the Wirral (UK)

When is the study starting and how long is it expected to run for?
September 2016 to April 2017

Who is funding the study?
Health Education England Innovation Fund (UK)

Who is the main contact?
Dr Helen Sharp
hmsharp@liv.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helen Sharp

ORCID ID

Contact details

Department of Psychological Science
Whelan Building
University of Liverpool
Liverpool
L69 3GB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Bid 210 Health Education England Innovation Fund

Study information

Scientific title

Supporting transition from primary to secondary school: using the Team of Life to improve psychosocial health and build resilience in UK school children

Acronym

Study hypothesis

Objective 1: To determine if conducting a cluster RCT trial to evaluate the group-based Team of Life intervention in a UK community school setting is feasible. Specifically the study aims to:
1. Assess whether the TOL intervention is acceptable to child participants – This will be assessed indirectly through adherence to attending TOL sessions and directly through qualitative post-intervention interviews
2. Determine if the process of random allocation is acceptable to parents, teachers and schools
3. Generate estimates of participation rates (proportion of those eligible) at point of recruitment, adherence to the TOL intervention, and follow-up / study attrition rates
4. Generate estimates of standard deviation for sample size calculation and intracluster correlations (ICCs) for the planning of a future large scale cluster RCT study
5. Use qualitative methodology to assess intervention staff’s adherence to the Team of Life narrative approach – implied by use of narrative terms, the Team of Life metaphor and evidence of appreciation of children’s narratives in the content of reflective diaries

Objective 2: To collect quantitative and qualitative feedback from pastoral / educational staff, recently trained in the TOL approach, regarding the quality of training received, the acceptability of the TOL approach and their subsequent experience of delivering TOL so as to inform any future workforce development plans.

Objective 3. To elicit peer mentor views from focus groups qualitative interviews regarding positive and negative experiences of supporting educational staff and pupils during delivery of the Team of Life.

Ethics approval

University of Liverpool Research Ethics Committee, 13/09/2016, ref: RETH001068

Study design

Pilot pragmatic cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Social, psychological or behavioural vulnerability identified by schools in the transition from primary to secondary school

Intervention

Schools will be randomised to deliver either the 'Team of Life' (with TAU) or 'Supported Transition as Usual' (TAU only) in a 1:1 allocation ratio in the autumn term of secondary school. Pairs of schools will be matched on type of student intake: single sex boys, single sex girls or mixed sex. Within each pair one school will be randomly allocated to each intervention arm.

The Team of Life (TOL): The Team of Life manualised programme (Eames & Denborough, 2015) is based upon the original Team of Life methodology. The programme is structured to support facilitators who are not narrative therapists to deliver the group-based intervention. It is suitable for groups of 8-14 young people and consists of ten 1-hour sessions. Each session includes a ‘warm up’ sporting related activity which links in with the session theme, a main narrative based activity and a mindfulness activity, which incorporates the sporting metaphor and serves as a ‘cool down’ at the end.
The aim of the intervention is to:
1. Enable young people to experience an enjoyable sense of teamwork.
2. Enable young people to identify key support people/team-mates in their lives and build a sense of connected identity.
3. Celebrate young people’s existing coping skills and resilience.
4. Enable young people to further develop coping skills and resilience.
5. Celebrate the goals and achievements young people and their families have already accomplished.
6. Enable young people to plan steps towards achieving future goals in life.
7. Improve psychological wellbeing at a time of transition.
8. Introduce the practice of mindfulness
(Note - Team of Life will be delivered in addition to supported Transition as Usual provided by each school)

Supported Transition As Usual (TAU): Secondary schools offer both universal and targeted approaches to support children during the transition to secondary school. Universally, all schools offer an Induction Day for students at the school and a parent open evening. Most also offer some choice regarding form tutor groups according to friendship preferences. Some also offer a summer school which when it is offered, has a high uptake. Enhanced school support is offered to children deemed to be vulnerable in transition for a variety of reasons. The type of enhanced support offered varies across schools but this commonly includes additional planned visits prior to transition and support from peer mentors or pastoral staff after starting.

The Team of Life Intervention consists of ten 50 minute sessions in school. Sessions will be run weekly in term time where possible but will ideally fall within a 20 week calendar period due to school holidays and school time-tabling conflicts. In the control schools baseline assessments and followup assessments will be completed at a parallel time point to the schools in the intervention arm.

Intervention type

Phase

Drug names

Primary outcome measures

Feasibility outcomes:
1. Recruitment rates for eligible pupils
2. Group attendance
3. Intervention completion
4. Attrition rates at follow-up
4. Parent/teacher/pupil questionnaire completion rates
5. Number and length of staff-facilitator supervision sessions during delivery of TOL (and any additional consultation time requested)

As this is a feasibility study and as such it does not have a primary outcome. A range of outcome measures will be included to assess their utility and acceptability within a future trial to generate estimates of standard deviation and ICCs for a range of candidate symptom and wellbeing outcome measures so as to inform sample size calculations for a future larger scale study:

1. Child Behaviour Checklist (CBCL), completed by pupil, parent, teacher report
2. The Strengths and Difficulties Questionnaire (SDQ) completed by pupil, parent, teacher report
3. Goal Based outcomes (GBO’s), using personalised goals set by pupil
4. The EPOCH Measure of Adolescent Wellbeing, completed by pupil only
5. The Warwick-Edinburgh Mental Well-being scale (WEMWBS) completed by pupil only
6. MacArthur Health and Behaviour Questionnaire HBQ- Teacher version 2.1 - Three subscales will be used to assess teacher report of child engagement with school, peer relations and social withdrawal

Outcomes will be measured at the start of the Intervention period and again at the end of the intervention period.

Secondary outcome measures

1. Pupil’s personal experiences of being part of the Team of Life within school is measured through a brief qualitative interview with children with open questions will be conducted at the end of the Team of Life
2. Peer mentor’s experiences of supporting the delivery of Team of Life within schools is assessed through a focus group with open questions at the end of the Team of Life
3. Education staff facilitator experience of delivering the Team of Life on a weekly basis and on the observed value and difficulties of using the group-based intervention is assessed through reviewing short reflective diaries kept throughout the intervention period

Overall trial start date

14/09/2016

Overall trial end date

30/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Year 7 pupil
2. Deemed by the schools to be in need of extra support in the transition from primary into secondary school

Participant type

Mixed

Age group

Child

Gender

Both

Target number of participants

8 clusters; 4 clusters in each arm; 14 pupils in each cluster (Maximum 112) so after estimated 30% attrition there will target of 40 pupils in each arm.

Participant exclusion criteria

1. Significant special educational needs
2. Severe mental health or behavioural difficulties, which in the Head Teacher’s view would prevent participation within a group without significant individual support

Recruitment start date

03/10/2016

Recruitment end date

30/11/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Liverpool
Department of Psychological Sciences
Liverpool
CH69 3GB
United Kingdom

Sponsor information

Organisation

Phil Elliott (Cheshire and Wirral Partnership NHS Foundation Trust)

Sponsor details

Redesmere
Trust Board Offices
Countess of Chester Heath Park
Liverpool Road
Chester
CH2 1BQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Health Education England Innovation Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication will be in a high-impact peer reviewed journal.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from hmsharp@liv.ac.uk

Intention to publish date

31/03/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes