Decision Aid for young people who Self­-Harm (DASH)

ISRCTN ISRCTN11230559
DOI https://doi.org/10.1186/ISRCTN11230559
Secondary identifying numbers N/A
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

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

Dr Sarah Rowe
Public

David Goldberg Building
De Crespigny Park
London
SE5 8AF
United Kingdom

Mr Paul Moran
Scientific

David Goldberg Building
De Crespigny Park
London
SE5 8AF
United Kingdom

Study information

Study designRandomised single-centre feasibility/pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)School
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleDecision Aid for young people who Self­-Harm (DASH): a feasibility trial
Study acronymDASH
Study hypothesisThe 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
ConditionSelf-harm
InterventionWe 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 typeBehavioural
Primary outcome measure1. Recruitment of young people and consent rates
­2. Feasibility and acceptability of randomisation procedures
­3. Follow-­up rates and response rates to questionnaires
Secondary outcome measuresDescriptive data on candidate outcome measures, in order to inform the design of an adequately powered, future efficacy study.
Overall study start date17/03/2015
Overall study end date31/12/2016

Eligibility

Participant type(s)Other
Age groupChild
Lower age limit12 Years
Upper age limit18 Years
SexBoth
Target number of participants60
Participant inclusion criteria1. Aged 12-18
2. Attending secondary school within the London borough of Southwark
3. Basic proficiency in English language
Participant exclusion criteriaLacking capacity to consent
Recruitment start date07/10/2015
Recruitment end date01/08/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Charter School
Red Post Hill
London
SE24 9JH
United Kingdom

Sponsor information

King's College London (UK)
University/education

Institute of Psychiatry/South London & Maudsley
P005
R & D Office, De Crespigny Park
London
SE5 8AF
England
United Kingdom

Website http://www.gsttcharity.org.uk/
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Charity

Guy's and St Thomas' Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 28/09/2016 Yes No
Results article results 30/01/2018 Yes No

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.