Decision Aid for young people who Self-Harm (DASH)
| ISRCTN | ISRCTN11230559 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11230559 |
| Protocol serial number | N/A |
| Sponsor | King's College London (UK) |
| Funder | Guy's and St Thomas' Charity |
- Submission date
- 13/05/2015
- Registration date
- 22/05/2015
- Last edited
- 20/09/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Self-harm is when a person deliberately hurts or injures their body, often as a way to punish themselves. Self-harm is a serious mental health problem that is usually carried out to help the individual cope with or express extreme emotional distress. It is also the strongest predictor of suicide and is especially common among young people, a group in whom rates of self-harm appear to be rising. There is evidence to suggest that young people who self-harm can find it hard to reach a decision about where and how to get help. While young people may be reluctant to seek help from healthcare professionals when distressed, many turn to the internet as a way of coping with psychological distress. A growing number of studies involving children and adolescents suggest positive effects of treatment programmes that make use of web-based technology. Therefore, a safe and effective, internet-based intervention for young people who self-harm could be of benefit to a large numbers of individuals. The aim of this study is to test the practicality, acceptability and potential effectiveness of a newly developed internet-based decision aid (DA) programme. The DA aims to help young people reach decisions regarding where they can go for help or support for their self-harm issues.
Who can participate?
Children aged 12-18 attending secondary school in Southwark, London.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) are given access to the DA programme. Those in group 2 (control group) are given standard information from their school counsellor. All participants are followed up 4 weeks after the start of the study to answer questions about their experiences during the study period.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
The Charter School (UK)
When is the study starting and how long is it expected to run for?
April 2015 to April 2016
Who is funding the study?
Guy's and St Thomas' Charity (UK)
Who is the main contact?
Dr S Rowe (public)
Dr P Moran (scientific)
Contact information
Public
David Goldberg Building
De Crespigny Park
London
SE5 8AF
United Kingdom
Scientific
David Goldberg Building
De Crespigny Park
London
SE5 8AF
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single-centre feasibility/pilot study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Decision Aid for young people who Self-Harm (DASH): a feasibility trial |
| Study acronym | DASH |
| Study objectives | The principal research objective of this trial is to assess the feasibility of undertaking a randomised controlled trial of the decision aid (DA), with respect to the following predefined parameters: 1. Recruitment of young people and consent rates 2. The feasibility and acceptability of randomisation procedures 3. Followup rates and response rates to questionnaires |
| Ethics approval(s) | London - Camberwell St Giles Research Ethics Committee, 00/02/2015 |
| Health condition(s) or problem(s) studied | Self-harm |
| Intervention | We invite young people (aged 12-18) to complete a questionnaire about their feelings and any self-harm behaviour they may have engaged in the previous year. Participants who report self-harm in the previous year will then be randomised to one of two groups: 1. Intervention group receiving the web-based DA 2. Control group receiving general information about feelings and emotions Both groups will be asked to complete some research scales about decision-making and help-seeking behaviour. Participants in both groups will be followed up at 4 weeks when we will repeat the scales. The researcher administering the 4-week scales will be blind to the original allocation status of the participants. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Recruitment of young people and consent rates |
| Key secondary outcome measure(s) |
Descriptive data on candidate outcome measures, in order to inform the design of an adequately powered, future efficacy study. |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Aged 12-18 2. Attending secondary school within the London borough of Southwark 3. Basic proficiency in English language |
| Key exclusion criteria | Lacking capacity to consent |
| Date of first enrolment | 07/10/2015 |
| Date of final enrolment | 01/08/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
SE24 9JH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 30/01/2018 | Yes | No | |
| Protocol article | protocol | 28/09/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/02/2018: Publication reference added.
30/09/2016: Publication reference added.
12/04/2016: the following changes were made to the trial record:
1. The overall trial start date was changed from 01/04/2015 to 17/03/2015.
2. The overall trial end date was changed from 01/04/2016 to 31/12/2016.
3. The recruitment start date was changed from 01/05/2015 to 07/10/2015.
4. The recruitment end date was changed from 01/03/2016 to 01/08/2016.
