Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Jonathan Green


Contact details

Jean McFarlane Building
Room 4.321
University of Manchester
Oxford Road
M13 9PL
United Kingdom
+44 (0)161 275 2000

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A two arm single blinded randomised allocation trial of a manualised group therapy in addition to usual care compared with usual care alone for adolescents who repeatedly harm themselves



Study hypothesis

1. To test the effect of the addition of a manualised group therapy intervention to usual care when treating adolescent repeated self harm
2. To explore the costs and cost-effectiveness of usual care plus group therapy compared to usual care alone

Ethics approval

Multi-centre Research Ethics Committee (MREC) approved in March 2002 (ref: 01-8-8)

Study design

Two arm single-blinded randomised allocation trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Self-harm (deliberate overdoses, cutting, burning, banging head, ligatures)


The experimental group therapy intervention is a manualised treatment specifically designed for adolescents who harmed themselves. The group treatment is based on cognitive behaviour and problem solving techniques. Techniques used in the group integrated empirically based conceptual approaches in common clinical practice within the NHS and advocated by several opinion leaders in the field of deliberate self harm. Participants were asked to attend four group therapy sessions. After this, they can access the group for as long as they are open to CAMHS.

Comparator - Routine Care:
Clinical centres provide routine care that they would normally provide to these patients. Treatment as usual is undertaken by the local CAMHS Team using established protocols and clinical practice. Centres agree that routine care will not include any group intervention.

For both arms of the trial, treatment was given for as long as the Care Manager though it was clinically needed. Some participants were in treatment for over a year.

Intervention type



Not Applicable

Drug names

Primary outcome measure

Frequency and severity of episodes of self harm assessed using an adapted self harm interview schedule. Steps will be taken with the interview schedule to minimise a recall bias towards more recent events and to get a clear picture of the pattern of self harm over the previous year. The self harm interview will be conducted by research assessors (blinded to treatment allocation) and additionally (to allow for reporting bias from young people) clinicians involved with the young person will also undertake the same interview.

Secondary outcome measures

1. Time to first and second repetition, number of severe suicidal acts (defined by medical risk of death)
2. Depression measured using the Moods and Feelings Questionnaire (MFQ)
3. Suicidality measured using the Suicidale Ideation Questionnaire
4. Global outcome assessed by the health of the nation outcome scales for children and adolescents (HoNOSCA)
5. Psychosocial stress assessed using the Kiddie Schedule for Affective Disorders and Scizophrenia (K-SADS)
6. Cost benefit analysis measured using the Service Use Inventory

All the above administered at baseline, 6 and 12 months. At 3 months an assessment to measure emerging personality problems was undertaken (SCID II).

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Aged 12 - 17 years, either sex
2. Referred to mental health services in Greater Manchester following self-harm
3. The adolescent reports that in the last year he or she has harmed themselves on at least one other occasion

Participant type


Age group




Target number of participants

156 cases in each group, we need to randomise 372 cases

Participant exclusion criteria

1. The adolescent cannot attend groups (e.g., in secure care)
2. Has a psychotic or eating disorder
3. Unlikely to benefit from groups (e.g., learning problems)
4. Non-English speakers

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Jean McFarlane Building
M13 9PL
United Kingdom

Sponsor information


University of Manchester (UK)

Sponsor details

Oxford Road
M13 9PL
United Kingdom
+44 (0)161 275 2000

Sponsor type




Funder type


Funder name

Mental Health Foundation (UK) - PPP Healthcare Trust (ref: 1727/1072)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

1. 2011 results in

Publication citations

  1. Results

    Green JM, Wood AJ, Kerfoot MJ, Trainor G, Roberts C, Rothwell J, Woodham A, Ayodeji E, Barrett B, Byford S, Harrington R, Group therapy for adolescents with repeated self harm: randomised controlled trial with economic evaluation., BMJ, 2011, 342, d682.

Additional files

Editorial Notes