Contact information
Type
Scientific
Primary contact
Prof Jonathan Green
ORCID ID
Contact details
Jean McFarlane Building
Room 4.321
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 2000
Jonathan.green@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1727/1072
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
Acronym
ASSIST
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Self-harm (deliberate overdoses, cutting, burning, banging head, ligatures)
Intervention
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.
Intervention type
Other
Phase
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
01/08/2002
Overall trial end date
01/06/2007
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Child
Gender
Both
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
01/08/2002
Recruitment end date
01/06/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Jean McFarlane Building
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 2000
david.walkden@manchester.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Mental Health Foundation (UK) - PPP Healthcare Trust (ref: 1727/1072)
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
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21459975
Publication citations
-
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.