Condition category
Mental and Behavioural Disorders
Date applied
15/07/2019
Date assigned
22/07/2019
Last edited
22/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Self-harm (intentional self-injury or poisoning) is common amongst young people aged 12-17 with up to one in six reporting self-harm at least once during the past year. Self-harm is linked to other mental health problems such as depression, anxiety and substance misuse and with an increased risk of suicide. Nearly all self-harm happens whilst the young person is on their own. However, most have access to a mobile phone at the time they harm themselves. Young people were consulted to develop an app that could provide them with help at times they were thinking of self-harming. Workshops were previously held with young people to design, develop and produce a smartphone app, BlueIce. The present study aims to test whether adding BlueIce to the usual care provided by specialist child and adolescent mental health services (CAMHS) for young people who self-harm reduces self-harm, improves how they feel and results in fewer emergency contacts.

Who can participate?
Young people aged 12-17 attending specialist CAMHS with a history of self-harm (i.e. 2 or more episodes of self-harm over the past 12 months).

What does the study involve?
The study will test whether adding BlueIce to the usual care provided by specialist child and adolescent mental health services (CAMHS) for young people who self-harm reduces self-harm, improves how they feel and results in fewer emergency contacts. Young people attending CAHMS will be allocated to usual care or usual care plus BlueIce. At the start of the study and after 12 and 26 weeks, self-harm, mood, feelings and any care received for self-harm (i.e. attending Emergency Departments) will be assessed.

What are the possible benefits and risks of participating?
We think that most young people taking part in this study will benefit from the research assessments which will monitor their progress. We do not expect any risks from participating in the study.

Where is the study run from?
Warneford Hospital, UK

When is the study starting and how long is it expected to run for?
January 2020 to August 2021

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

Who is the main contact?
Prof. Paul Stallard
paul.stallard@oxfordhealth.nhs.uk

Trial website

https://www.oxfordhealth.nhs.uk/blueice

Contact information

Type

Scientific

Primary contact

Prof Paul Stallard

ORCID ID

http://orcid.org/0000-0001-8046-0784

Contact details

Oxford Health NHS Foundation Trust
Work Address CAMHS
Temple House
Keynsham
BS31 1HA
United Kingdom
01865903889
paul.stallard@oxfordhealth.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

42159

Study information

Scientific title

A comparison of usual care versus usual care plus a smartphone self-harm prevention app (BlueIce) in young adolescents aged 12-17 who self-harm: Beating Adolescent Self-Harm (BASH) - Version 1

Acronym

BASHv1

Study hypothesis

The addition of BlueIce to usual care will result in less self-harm, improved psychological wellbeing and will be cost-effective

Ethics approval

Approved 11/06/2019, South Central - Oxford B Research Ethics Committee (Whitefriars, Level 3, Block B, Lewin's Mead, Bristol, BS1 2NT; 020 7104 8049; nrescommittee.southcentral-oxfordb@nhs.net), ref: 19/SC/0212

Study design

Randomised; Interventional; Design type: Treatment, Prevention, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

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

Condition

Self-harm

Intervention

The study will test whether adding BlueIce to the usual care provided by specialist child and adolescent mental health services (CAMHS) for young people who self-harm reduces self-harm, improves how they feel and results in fewer emergency contacts. Young people attending CAHMS will be allocated to usual care or usual care plus BlueIce. At the start of the study and after 12 and 26 weeks, self-harm, mood, feelings and any care received for self-harm (i.e. attending Emergency Departments) will be assessed.

Our assessment of self-harm will consist of three parts: a brief interview, completion of the Risk-Taking and Self-harm Inventory and the provision of support and advice.
Part A: Interview. We will use items from the Avon Longitudinal Study of Parents and Children (ALSPAC) (http://www.alspac.bris.ac.uk). Young people will be asked “have you ever hurt yourself on purpose in any way (e.g. by taking an overdose of pills or by cutting yourself) over the past 3 months?” Those who answer yes will be asked further questions about frequency, method, reason for self-harming, whether they sought medical help and suicidal intent.
PART B: RTSHIA. Our primary outcome is self-reported self-harm assessed by the self-harm inventory of the RTSHIA. The RTSHIA was developed in the UK for use with adolescents (aged 11-19 years). It has been used as the primary outcome measure for a recent UK study evaluating a self-harm intervention for young people undertaken in the same setting (CAMHS teams) as we propose. The inventory assesses the presence and frequency of a range of intentional self-injury (e.g. cutting, burning, self-hitting, self-poisoning) over a defined period. We will quantify the frequency of self-harm and will ask additional questions to clarify whether they sought medical help and suicidal intent. The RTSHIA has good reliability and validity. We will use information from this to categorise changes in self-harm from baseline to 12 weeks and 6 months as reduced/stopped vs same/increased.
Part C: Support and Advice. At the end of the assessment young people will be given a list of contacts they can call if they are feeling worried about themselves.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Self-reported self-harm assessed by the self-harm inventory of the RTSHIA at baseline, 12 weeks and six months

Secondary outcome measures

1. Anxiety, measured by the Revised Child Anxiety and Depressions Scale (RCADS) at baseline, post-intervention (12 weeks) and follow-up (6 months)
2. Depression, assessed by the Mood and Feelings Questionnaire (MFQ) at baseline, post-intervention (12 weeks) and follow-up (6 months)
3. Hopelessness, assessed by The Beck Hopelessness Scale at baseline, post-intervention (12 weeks) and follow-up (6 months)
4. General behaviour, assessed by the Strengths and Difficulties Questionnaire (SDQ) at baseline, post-intervention (12 weeks) and follow-up (6 months)
5. Health-related quality of life (HRQoL), assessed by the Child Health Utility 9D (CHUD 9D) at baseline, post-intervention (12 weeks) and follow-up (6 months)

Overall trial start date

01/06/2019

Overall trial end date

31/08/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 12-17
2. Attending specialist CAMHS
3. History of self-harm (i.e. 2 or more episodes of self-harm over the past 12 months)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 172; UK Sample Size: 172

Participant exclusion criteria

1. Suicidal
2. Diagnosed with psychosis
3. Current safeguarding concerns (i.e. the young person has suffered abuse within the last 6 months or is the subject of a safeguarding investigation),
4. Significant developmental disorder (e.g. autism) which interferes with their ability to use the app
5. Insufficient understanding of English in order to use BlueIce. At present, BlueIce is only available in English.

Recruitment start date

01/01/2020

Recruitment end date

31/08/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Warneford Hospital
Warneford Lane
Oxford
OX3 7JX
United Kingdom

Sponsor information

Organisation

Oxford Health NHS Foundation Trust

Sponsor details

Corporate Headquarters
4000 John Smith Drive
Oxford Business Park South
OXFORD
OX3 7JX
United Kingdom
-
abc@email.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: PB-PG-1217-20004

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

31/08/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/07/2019: Trial’s existence confirmed by NIHR.