Support Centre
31 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

New application
Updating record

governing board
data set
letter of agreement
request information
guidance notes

[ Print-friendly version ]
Group therapy for adolescents who repeatedly harm themselves
DOI 10.1186/ISRCTN20496110
ClinicalTrials.gov identifier
EudraCT number
Public title Group therapy for adolescents who repeatedly harm themselves
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
Acronym ASSIST
Serial number at source 1727/1072
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
Lay summary
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
Countries of recruitment United Kingdom
Disease/condition/study domain Self-harm (deliberate overdoses, cutting, burning, banging head, ligatures)
Participants - 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
Participants - 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
Anticipated start date 01/08/2002
Anticipated end date 01/06/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 156 cases in each group, we need to randomise 372 cases
Interventions Intervention:
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.
Primary outcome measure(s) 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 measure(s) 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).
Sources of funding Mental Health Foundation (UK) - PPP Healthcare Trust (ref: 1727/1072)
Trial website
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21459975
Contact name Prof  Jonathan  Green
  Address Jean McFarlane Building
Room 4.321
University of Manchester
Oxford Road
  City/town Manchester
  Zip/Postcode M13 9PL
  Country United Kingdom
  Tel +44 (0)161 275 2000
  Email Jonathan.green@manchester.ac.uk
Sponsor University of Manchester (UK)
  Address Oxford Road
  City/town Manchester
  Zip/Postcode M13 9PL
  Country United Kingdom
  Tel +44 (0)161 275 2000
  Email david.walkden@manchester.ac.uk
  Sponsor website: http://www.manchester.ac.uk/
Date applied 16/06/2009
Last edited 06/04/2011
Date ISRCTN assigned 19/08/2009
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.