Submission date
23/01/2004
Registration date
23/01/2004
Last edited
21/12/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Retrospectively registered
? Protocol not yet added
? SAP not yet added
Results added
? Raw data not yet added
Study completed

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

Prof Richard Harrington

ORCID ID

Contact details

School of Psychiatry and Behavioural Sciences
Royal Manchester Children's Hospital
Hospital Road
Pendlebury
Manchester
M27 4HA
United Kingdom
+44 (0)161 764 4696

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

RHC33008

Study information

Scientific title

Acronym

Study hypothesis

The main aim of the study would be to compare the routine clinical care of adolescents who have repeatedly harmed themselves with routine clinical care plus a six month group-based intervention. By the end of the studentship evidence would be gathered to indicate whether this would lead to improvements in depression and suicidal scores and in other areas of psychosocial functioning such as social relationships and whether the intervention would lead to higher levels of client satisfaction than routine clinical care.

Ethics approval(s)

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Other

Study type

Treatment

Patient information sheet

Condition

Other mental disorder

Intervention

1. Routine care plus six month group-based intervention
2. Routine care

Intervention type

Other

Primary outcome measure

1. Repeated self-harm
2. Depression

Secondary outcome measures

Not provided at time of registration

Overall study start date

01/10/1997

Overall study end date

01/10/2000

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Repeated self-harm
2. Adolescents aged 12-16 years

Participant type(s)

Patient

Age group

Child

Lower age limit

12 Years

Upper age limit

16 Years

Sex

Both

Target number of participants

63 (added 18/12/09)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/10/1997

Recruitment end date

01/10/2000

Locations

Countries of recruitment

England, United Kingdom

Study participating centre

School of Psychiatry and Behavioural Sciences
Manchester
M27 4HA
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive North West (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2001 Yes No

Additional files

Editorial Notes