Condition category
Mental and Behavioural Disorders
Date applied
30/08/2016
Date assigned
23/09/2016
Last edited
23/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
In England, between 3-7% of school aged children experience behavioural difficulties. Behavioural difficulties can have a negative long-term impact. For example, evidence shows that behavioural difficulties may predict worse academic attainment and higher levels of school dropout. Recent policy calls for schools to help students to manage behavioural difficulties. ReZone is a smartphone app for young people to use when they feel overwhelmed, stressed or anxious in class. The app aims to help students manage how they are feeling so they can ReZone and return to learning. It contains a series of tools which are designed to improve concentration, help relieve stress and help students to reflect and think through problems logically, through use of metalisation based therapy (a type of therapy that helps popeple separate their thoughts and feelings from those around them) and cognitive behaviour therapy (a type of therapy aiming to help people to change negative behaviour patterns) techniques. The aim of this study is to test the effectiveness of ReZone at reducing emotional and behavioural difficulties in young people in need of targeted support to engage with school.

Who can participate?
Young people aged 11-14 years who attend alternative provision schools

What does the study involve?
Classes are randomly allocated to one of two groups. Students in the first group are given access to the ReZone app, which they are able to download on their smartphones, for 12 weeks. They are able to use the app whenever they are feeling overwhelmed, stressed or anxious, either of their own accord or be directed by teachers to use it in class. The app contains tools based on different types of behavioural therapy and works to help students calm and re-focus quickly, enabling them to re-engage with their learning. Students in the second group continue as normal for the duration of the study. At the start of the study and then again after 12 weeks, students in both groups complete a range of questionnaires to measure their emotional and behavioural difficulties, mental wellbeing and self-management.

What are the possible benefits and risks of participating?
There is no guaranteed benefit in taking part. One advantage is that participants will get to help shape an app that will benefit young people in future. Most people find taking part in research rewarding, as they contribute to the development of knowledge that may benefit other people in the future. After the study has ended, all classes in schools taking part in the project will be able to use ReZone if they wish. There are no notable risks involved with participating in this study.

Where is the study run from?
The study is run by University College London and the Anna Freud National Centre for Children and Families and takes place in alternative provision schools in England (UK)

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

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

Who is the main contact?
Dr Julian Edbrooke-Childs

Trial website

Contact information

Type

Scientific

Primary contact

Dr Julian Edbrooke-Childs

ORCID ID

http://orcid.org/0000-0003-0401-4058

Contact details

The Anna Freud Centre and University College London
12 Maresfield Gardens
London
NW3 5SU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7969/001

Study information

Scientific title

Cluster randomized control trial of ReZone: Helping young people to self-manage when feeling overwhelmed

Acronym

Study hypothesis

Primary aim:
To examine the effectiveness of an mHealth intervention (ReZone) in reducing emotional and behavioural difficulties in young people in need of targeted support to engage with school.

Secondary aim:
To examine the effectiveness of ReZone in improving self-management, well-being, and health-related quality of life in young people in need of targeted support to engage with school.

Ethics approval

Not provided at time of registration

Study design

Cluster randomised control study

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 the contact details below to request a patient information sheet

Condition

Emotional and behavioural difficulties in young people

Intervention

Classes are randomly allocated to the intervention or control arm using a random sequence generator by an independent trials unit.

Intervention arm: Students will be given access to the ReZone app for 12 weeks. They are able to download the ReZone app from the iTunes, Google play, and Windows app stores. Students can then use the app as much as they like, using the tools on the platform as well as being able to download flat graphics of tools. Students can use ReZone of their own accord or be directed by teachers to use it during classes at times the students is becoming overwhelmed. ReZone contains four tools based on art therapy, metallisation based therapy, and cognitive behaviour therapy techniques: the ‘stress bucket’ exercise, ‘time out’ incident clock, art zone, and mindfulness breathing.

Control arm: Students continue as normal for the duration of the study.

Participants in both groups complete measures of emotional and behavioural difficulties, mental wellbeing, self-management, and health-related quality of life at baseline and 12 weeks.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Emotional and behavioural difficulties are measured using the 16-item Me and My School (M&MS) at baseline and 12 weeks completed by students.

Secondary outcome measures

1. Mental wellbeing is measured using the 7-item Short Warwick-Edinburg Mental Well-being Scale (SWEMWBS) at baseline and 12 weeks completed by students
2. Self-management is measured using the 6-item “self” subscale of the Youth Empowerment Scale-Mental Health (YES-MH) at baseline and 12 weeks completed by students
3. Health-related quality of life is measured using the 6-item EQ-5D-Y at baseline and 12 weeks completed by students

Overall trial start date

01/06/2016

Overall trial end date

30/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Young people aged 11-14 years
2. Attending alternative provision schools
3. Able to understand English sufficiently to take part

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Children (<11 years)
2. Adults (>15)
3. Not attending alternative provision schools
4. Not able to understand English sufficiently to take part

Recruitment start date

01/11/2016

Recruitment end date

28/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
WC1E 6BT

Trial participating centre

Anna Freud National Centre for Children and Families
NW3 5SU

Sponsor information

Organisation

University College London

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

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

Planned publication in a high-impact peer reviewed journal.

Intention to publish date

30/11/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes