Group therapy for adolescents who repeatedly harm themselves
| ISRCTN | ISRCTN20496110 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20496110 |
| Secondary identifying numbers | 1727/1072 |
- Submission date
- 16/06/2009
- Registration date
- 19/08/2009
- Last edited
- 06/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jonathan Green
Scientific
Scientific
Jean McFarlane Building
Room 4.321
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)161 275 2000 |
|---|---|
| Jonathan.green@manchester.ac.uk |
Study information
| Study design | Two arm single-blinded randomised allocation trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 acronym | ASSIST |
| Study objectives | 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(s) | Multi-centre Research Ethics Committee (MREC) approved in March 2002 (ref: 01-8-8) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/08/2002 |
| Completion date | 01/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 156 cases in each group, we need to randomise 372 cases |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 01/06/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Jean McFarlane Building
Manchester
M13 9PL
United Kingdom
M13 9PL
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Phone | +44 (0)161 275 2000 |
|---|---|
| david.walkden@manchester.ac.uk | |
| Website | http://www.manchester.ac.uk/ |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Charity
Mental Health Foundation (UK) - PPP Healthcare Trust (ref: 1727/1072)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2011 | Yes | No |
