Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000532303
Ethics application status
Approved
Date submitted
30/09/2008
Date registered
17/10/2008
Date last updated
17/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Group psychotherapy to reduce the repetition of self-harm in adolescents
Scientific title
An Australian randomized trial of a group psychotherapy program
to reduce the rate of repetition of self-harm in adolescents: Replication and extension of a British study.
Universal Trial Number (UTN)
Trial acronym
MoSH (Moving on from Self-Harm)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deliberate self-harm 3774 0
Condition category
Condition code
Mental Health 3948 3948 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The group intervention is informed by the principles of cognitive behavior therapy, social skills training, interpersonal psychotherapy and group psychotherapy, and is explicitly described in a treatment manual developed by Drs Alison Wood and Gemma Trainor from Manchester, UK. It consists of an initial engagement phase provided over six sessions, and optional attendance at a long-term group. Groups are held for one hour per week and provided by clinicians from community-based adolescent mental health services. The group intervention aims to support young people at a difficult time by teaching them problem solving skills and cognitive strategies to deal with their problems. The intervention is delivered in a manner that may engage ‘hard to reach’ young people. The initial six sessions of the group are orientated around six themes of relevance to adolescents who self-harm: relationships, school and peer relationships, family problems, anger management, depression and self-harm, and hopelessness and feelings about the future. After completion of the initial six sessions, adolescents may transition to a longer term group. This places more emphasis on the group process, but continues to use strategies and techniques used in the initial phase. The long term group is available one hour per week and duration of treatment is open-ended. In practice most participants exit the group within 12 months. Further self-harming does not disqualify participants from attending the group. Concurrent with the group therapy participants also receive routine care as needed, which may include individual counseling (using a variety of therapeutic approaches), family sessions, medication assessment and review and other care coordination activities. Duration of routine treatment is open-ended and is determined by clinical need. Access to longer term group therapy and to routine care is available to participants beyond their 12 month period of enrolment in the trial.
Intervention code [1] 3487 0
Treatment: Other
Comparator / control treatment
Routine treatment is provided by community-based adolescent mental health services and is monitored via the self-report resource use survey completed at outcome assessment points, and the collection of information from electronic health records used in each site. Routine care can be varied, but generally consists of individual counseling (using a variety of therapeutic approaches), family sessions, medication assessment and review and other care coordination activities. Duration of treatment is open-ended and is determined by clinical need. Access to routine care is available to participants beyond their 12 month period of enrolment in the trial.
Control group
Active

Outcomes
Primary outcome [1] 4845 0
The primary outcome measure is repetition of self-harm, as assessed by a portion of an interview-based assessment of suicidal behavior (Linehan M. Parasuicide History Interview. Seattle: University of Washington, 1999.)
Timepoint [1] 4845 0
7 weeks
6 months
12 months
Secondary outcome [1] 8187 0
Suicidal ideation as measured by the Suicidal Ideation Questionniare
Timepoint [1] 8187 0
7 weeks
6 months
12 months

Eligibility
Key inclusion criteria
Participants were eligible if they were; (1) aged between 12 and16 years, (2) had been referred to a child and adolescent mental health service in Australian sites at Newcastle, Brisbane North or Logan, and (3) reported at least two episodes of self-harm in the past year, one of which had occurred in the past three months. Deliberate self-harm was defined as any intentional self-inflicted injury (including poisoning) irrespective of the apparent purpose of the behavior. Poisoning as a result of excessive use of recreational drugs was excluded from this definition.
Minimum age
12 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants were deemed ineligible if (1) they required continual monitoring due to suicidal ideation; (2) their current situation meant they could not attend groups; (3) they were experiencing acute psychosis, or (4) they exhibited difficulties or presenting issues that indicated that they would be unlikely to benefit from the group intervention (e.g. intellectual disability).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The unit of randomization was the adolescent. After written consent was obtained, the local site coordinator emailed the distant site coordinator who assigned a trial number and randomly allocated that adolescent to group therapy or routine care using a computer generated table of random numbers. The adolescent was informed of their allocation by a letter and by their routine care therapist, and group therapists liaised with adolescents as to an appropriate starting date for those randomized to the group intervention (based on group phase and schedule).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated table of random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Treatment allocation was concealed from the outcome assessors, who were asked at the end of the study to nominate which treatment had been given to the adolescents.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1179 0
2303
Recruitment postcode(s) [2] 1180 0
4006
Recruitment postcode(s) [3] 1181 0
4114

Funding & Sponsors
Funding source category [1] 3954 0
Charities/Societies/Foundations
Name [1] 3954 0
American Foundation for Suicide Prevention
Country [1] 3954 0
United States of America
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan
NSW 2008
Country
Australia
Secondary sponsor category [1] 3542 0
University
Name [1] 3542 0
University of Queensland
Address [1] 3542 0
Herston Rd
Herston
Queensland 4006
Country [1] 3542 0
Australia
Other collaborator category [1] 438 0
Individual
Name [1] 438 0
Professor Graham Martin
Address [1] 438 0
University of Queensland
Herston Rd
Herston
Queensland 4006
Country [1] 438 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6014 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 6014 0
Locked Bag No 1
New Lambton
NSW 2305
Ethics committee country [1] 6014 0
Australia
Date submitted for ethics approval [1] 6014 0
Approval date [1] 6014 0
21/07/2004
Ethics approval number [1] 6014 0
04/07/21/3.05

Summary
Brief summary
This study aims to replicate, in an Australian context, on a larger scale and over a longer time period, the only intervention shown to be effective in reducing the repetition of self harm in adolescents. Adolescents attending clinical mental health services at three sites in Australia who report having engaged in two or more episodes of self harm in the past year will be invited to participate in a trial designed to establish the efficacy of a group psychotherapy program aimed specifically at the adolescent self harming population. Participants will be randomly allocated to receive treatment as usual or group psychotherapy in addition to usual care. The major outcomes assessed at baseline, 7, 26 and 52 weeks will be the repetition of self harm, suicidal ideation and level of depression. If benefits are replicated, this approach will represent the only intervention shown to be reliably effective in reducing the repetition of self harm in adolescents whilst demonstrating an efficient, economic and generalizable means of assisting an at risk and difficult to reach population.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 28991 0
Address 28991 0
Country 28991 0
Phone 28991 0
Fax 28991 0
Email 28991 0
Contact person for public queries
Name 12148 0
Katherine McGill
Address 12148 0
Hunter Institute for Mental Health
PO Box 833, Newcastle, NSW, 2300
Country 12148 0
Australia
Phone 12148 0
+61-2-49 246 783
Fax 12148 0
+61-2-49 246 608
Email 12148 0
[email protected]
Contact person for scientific queries
Name 3076 0
Philip Hazell
Address 3076 0
Thomas Walker Hospital (Rivendell)
Hospital Rd
Concord West 2138
Country 3076 0
Australia
Phone 3076 0
+61-2-97362288
Fax 3076 0
+61-2-97436264
Email 3076 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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