Condition category
Mental and Behavioural Disorders
Date applied
13/05/2015
Date assigned
22/05/2015
Last edited
30/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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)

Trial website

Contact information

Type

Public

Primary contact

Dr Sarah Rowe

ORCID ID

Contact details

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

Type

Scientific

Additional contact

Mr Paul Moran

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Decision Aid for young people who Self­-Harm (DASH): a feasibility trial

Acronym

DASH

Study hypothesis

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

London - Camberwell St Giles Research Ethics Committee, 00/02/2015

Study design

Randomised single-centre feasibility/pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

Primary outcome measures

1. 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 measures

Descriptive data on candidate outcome measures, in order to inform the design of an adequately powered, future efficacy study.

Overall trial start date

17/03/2015

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 12-18
2. Attending secondary school within the London borough of Southwark
3. Basic proficiency in English language

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Lacking capacity to consent
2. Poor English language proficiency

Recruitment start date

07/10/2015

Recruitment end date

01/08/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

King's College London (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.gsttcharity.org.uk/

Funders

Funder type

Charity

Funder name

Guy's and St Thomas' Charity

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration.

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27683517

Publication citations

Additional files

Editorial Notes

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.