Beating Adolescent Self Harm (BASH)
| ISRCTN | ISRCTN10541045 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10541045 |
| Secondary identifying numbers | CPMS 42159 |
- Submission date
- 15/07/2019
- Registration date
- 22/07/2019
- Last edited
- 17/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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 December 2022
Who is funding the study?
National Institute for Health Research (NIHR)
Who is the main contact?
Prof. Paul Stallard
paul.stallard@oxfordhealth.nhs.uk
Contact information
Scientific
Oxford Health NHS Foundation Trust
Work Address CAMHS
Temple House
Keynsham
BS31 1HA
United Kingdom
 ORCID ID |
0000-0001-8046-0784 |
|---|---|
| Phone | 01865903889 |
| paul.stallard@oxfordhealth.nhs.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Prevention, Psychological & Behavioural |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study 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(s) | 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 |
| 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 |
| 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 | Current secondary outcome measures as of 15/06/2023: 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. Insomnia assessed by the Sleep Condition Indicator (SCI) at baseline, post intervention (12 weeks) and 6 months. 6 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) Previous 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 study start date | 01/06/2019 |
| Overall study end date | 23/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 170; UK Sample Size: 170 |
| Total final enrolment | 170 |
| Participant inclusion criteria | 1. Aged 12-17 years 2. Attending specialist CAMHS 3. History of self-harm (i.e. 2 or more episodes of self-harm over the past 12 months) |
| 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 | 07/07/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oxford
OX3 7JX
United Kingdom
Sponsor information
Hospital/treatment centre
Corporate Headquarters
4000 John Smith Drive
Oxford Business Park South
OXFORD
OX3 7JX
England
United Kingdom
| abc@email.com | |
"ROR" |
https://ror.org/04c8bjx39 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 27/07/2021 | 19/05/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 10/06/2024 | 17/06/2024 | Yes | No |
Additional files
Editorial Notes
17/06/2024: Publication reference added.
07/12/2023: The intention to publish date was changed from 31/12/2023 to 01/06/2024.
15/06/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 30/06/2022 to 07/07/2022.
2. The overall study end date was changed from 30/06/2023 to 23/12/2022.
3. The target number of participants was changed from Planned Sample Size: 172; UK Sample Size: 172 to Planned Sample Size: 170; UK Sample Size: 170.
4. Total final enrolment added.
5. The secondary outcome measures were updated.
19/05/2023: Uploaded protocol (not peer-reviewed) as an additional file.
18/08/2021: The intention to publish date has been changed from 31/08/2022 to 31/12/2023.
17/08/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/08/2021 to 30/06/2022.
2. The overall trial end date has been changed from 31/08/2022 to 30/06/2023 and the plain English summary has been updated accordingly.
22/07/2019: Trial’s existence confirmed by NIHR.
