Condition category
Mental and Behavioural Disorders
Date applied
19/03/2020
Date assigned
20/03/2020
Last edited
20/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The rates of mental health problems in children and young people (CYP) are estimated to be much higher than previously thought, with two in five CYP reporting increased symptomatology. Poor mental health has been connected to poor developmental outcomes, such as lower academic achievement, poor peer and school relationships, and lower well-being. Cost-effective and feasible interventions are thus urgently needed for the improvement of mental health outcomes and promotion of wellbeing in CYP. Schools are considered an ideal setting for the monitoring and promotion of mental health, given how much time CYP spend in these. The current study thus aims to assess the effectiveness of the Bounce Back (BB), a group-based intervention program delivered in schools. BB aims to improve pupil understanding of resilience and wellbeing, provide practical skills to make positive behaviour changes, support pupils to build their confidence and friendships. These outcomes are hoped to support a positive transition to secondary school.

Who can participate?
Young people in Years 5 or 6 attending primary schools in Newham that implement the BB intervention reporting at least one indicator of emerging mental health difficulty (a mild or moderate emotional, behavioural, attention, or relationship difficulty).

What does the study involve?
Primary schools in Newham are randomly allocated into one of two groups:
1. Participate in Bounce Back (BB) during the 2019 Autumn term
2. Be part of a waitlist comparison group who will participate in BB in 2020 Spring-Summer term
The Bounce Back programme is delivered for one hour per week for 10 weeks.

What are the possible benefits and risks of participating?
There are no known risks/disadvantages to completing the intervention. There are no guaranteed benefits, however most people find taking part in research projects rewarding, as it may help to improve services for young people, and to find out about things that may benefit other people in the future.

Where is the study run from?
London Borough of Newham Children’s Health and HeadStart Newham CYPS (UK)

When is the study starting and how long is it expected to run for?
May 2019 to October 2020

Who is funding the study?
National Lottery Community Fund (UK)

Who is the main contact?
Prof Neil Humphrey (scientific)
neil.humphrey@manchester.ac.uk
Elizabeth Ville (public)
Elizabeth.Ville@newham.gov.uk

Trial website

https://www.headstartnewham.co.uk/activities/bounceback-newham/

Contact information

Type

Scientific

Primary contact

Prof Neil Humphrey

ORCID ID

http://orcid.org/0000-0002-8148-9500

Contact details

University of Manchester
Manchester Institute of Education
Ellen Wilkinson Building
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 3404
neil.humphrey@manchester.ac.uk

Type

Public

Additional contact

Ms Elizabeth Ville

ORCID ID

Contact details

London Borough of Newham Children’s Health and HeadStart Newham CYPS
3rd Floor East Wing Newham Dockside
1000 Dockside Road
London
E16 2QU
United Kingdom
+44 (0)203 373 8600
Elizabeth.Ville@newham.gov.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Bounce Back: Randomized trial of a brief, school-based group intervention for children with emergent mental health difficulties

Acronym

Study hypothesis

The principal questions of the current study are:
RQ1. What is the impact of BounceBack Newham intervention on participants’ self-reported emotional (Me and My Feelings) scores?
RQ2. What is the impact of BounceBack Newham intervention on participants’ self-reported behavioural (Me and My Feelings) scores?
RQ3. What is the impact of BounceBack Newham intervention on participants’ self-reported self-esteem (SRS-Self-esteem) scores?
RQ4. What is the impact of BounceBack Newham intervention on participants’ self-reported problem solving skills (SRS-Problem-solving) scores?
RQ5. Is the impact of BounceBack Newham intervention on the above outcomes moderated by attendance rates?
RQ6. Is the impact of BounceBack Newham intervention on the above outcomes sustained over time?

Ethics approval

Approved 28/05/2019, UCL Research Ethics Committee (Office of the Vice-Provost (Research) University College London, Taviton St, London, WC1E 6BT, UK; +44 (0)20 7679 8717; ethics@ucl.ac.uk), ref: 6299/004

Study design

Waitlist cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Quality of life

Patient information sheet

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

Condition

Child mental health

Intervention

A sample of 24 primary schools in Newham are randomly allocated into one of two groups:
1. Participate in Bounce Back (BB) during the 2019 Autumn term
2. Be part of a waitlist comparison group who will participate in BB in 2020 Spring-Summer term

Randomization took place at the school level and was balanced on year group (5 vs. 6).

Dose: Weekly 1-hour facilitated group activities
Duration: One school term (10 weeks)
How it is administered: Young people work as a group, which is facilitated by a Youth Practitioner, to identify and learn about 10 different life areas and how these link to maintaining wellbeing and emotional resilience. Using an action learning approach, “plan, do, review”, each participant sets a personal behaviour change challenge each week and rates their progress towards achieving it. Participants are provided with a workbook to guide their learning.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Emotional symptoms, measured using the Me and My Feelings at baseline and 10-weeks

Secondary outcome measures

At baseline and 10-weeks:
1. Behavioral problems measured using the Me and My Feelings tool
2. Self-esteem measured using the Student Resilience Survey
3. Problem-solving skills measured using the Student-Resilience Survey

Overall trial start date

24/01/2019

Overall trial end date

31/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Attending primary schools in Newham that implement the BB intervention
2. In Years 5 or 6
3. Reporting at least one indicator of emerging mental health difficulty (a mild or moderate emotional, behavioural, attention, or relationship difficulty) as assessed by the professional recommending or themself
4. Following receipt of recommendation, 1:1 screening between young person and youth practitioner to determine level of difficultly and willingness to take part in BB

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

25 schools (390 children)

Participant exclusion criteria

1. Returned a parental opt-out
2. Currently under the care of CAMHS

Recruitment start date

01/05/2019

Recruitment end date

31/05/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

London Borough of Newham Children’s Health and HeadStart Newham CYPS
3rd Floor East Wing Newham Dockside 1000 Dockside Road
London
E16 2QU
United Kingdom

Sponsor information

Organisation

Anna Freud Centre

Sponsor details

The Kantor Centre of Excellence
4-8 Rodney Street
London
N1 9JH
United Kingdom
+44 (0)20 7794 2313
jessica.deighton@annafreud.org

Sponsor type

Charity

Website

http://www.annafreud.org/

Funders

Funder type

Charity

Funder name

National Lottery Community Fund

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

31/05/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/03/2020: Trial’s existence confirmed by UCL.