Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000569000
Ethics application status
Approved
Date submitted
26/06/2010
Date registered
14/07/2010
Date last updated
26/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
RE:SOLVE - Exploring the acceptability and feasibility of a Problem Solving Therapy programme for young people at risk of self harm.
Scientific title
RE:SOLVE - Exploring the acceptability and feasibility of a Problem Solving Therapy programme for young people at risk of self harm.
Secondary ID [1] 252113 0
N/A
Universal Trial Number (UTN)
U1111-1115-6889
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Self harm 257660 0
Problem Solving Skills 257661 0
Condition category
Condition code
Mental Health 257843 257843 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of 6 - 10 one hour sessions of one to one Problem Solving Therapy(PST) after a presentation to Child and Adolescent Mental Health Services, school guidance counsellor, or mental health practitioner in a Primary Health organsiation, following an episode of self harm, or at risk of self harm. The sessions are delivered by either a school guidance counsellor, a practitioner in the PHO, or a practitiner in the CAMHS, who has completed the RE:SOLVE training workshop.Ideally the client will receive 2 sessions in the first week to get the therapy well underway. After this, sessions will be weekly. PST is a psycho educational approach in which the therapist works with the client to learn a problem solving process and apply it to their (the client's) real life problems. They learn problem identification and definition, solution generation, solution evaluation and selection, making a plan to carry out a solution, carrying out the plan, and evaluating the solution. The sessions take place over a maximum of a three month period. The variation in the number of sessions received is based on how quickly and thoroughly the client learns the problem solving process and the constraints (or non existence of) within the work place of the various practitioners. For example, the PHO has only 4-6 sessions with each client, whereas the school guidance counsellors are not restricted in their number of sessions. The CAMHS in the study don't have strict limitations either. Clients are followed up 3 months after the therapy ends so remain involved in the study for 6 months. This has been re designed as an open trial so there will be no control group. Instead all clients who are eligible for the study and who wish to take part, will be able to do so. This will enable us to better assess the acceptability and feasibility of the RE:SOLVE problem solving pathway. It also makes the study more accessible to participating agencies.
Intervention code [1] 256732 0
Treatment: Other
Intervention code [2] 256788 0
Behaviour
Intervention code [3] 256789 0
Prevention
Comparator / control treatment
There will be no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258701 0
Mood as measured by the Reynolds Adolescent Depression Scale, administered by the principal investigator.
Timepoint [1] 258701 0
Baseline, 3 months following the self harm episode at the end of the Problem Solving Therapy (PST) treatment, and follow up at 6 months following the self harm episode
Secondary outcome [1] 264728 0
Problem Solving Skills as measured by the SPSI-A (Social Problem Solving Skills Inventory - Adolescent) administered by the principal investigator
Timepoint [1] 264728 0
Baseline, 3 months following the self harm episode at the end of the PST treatment, and follow up at 6 months following the self harm episode

Eligibility
Key inclusion criteria
Eligibility criteria for CAMHS and PHO environments are as follows:
* Referral to the service occurs following a first episode of self harm OR
* Referral to the service occurs amid concerns about self harm with a history of at least one previous episode of self harm OR
* Currently involved with the service and self harms during study period
* Between the ages of 13 and 18 years inclusive
* Cognitively able to cope with therapy
* Fluency in English

Eligibility criteria for school environment are as follows:
* Client presents at mild to moderate risk of self harm
* Client is not accepted by CAMHS following a referral OR
* Client does not meet the criteria for a referral to CAMHS
* Between the ages of 13 and 18 years inclusive
* Cognitively able to cope with therapy
* Fluency in English
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current psychosis
- Involvement with another study

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)
Once a potential participant has been deemed eligible, they will be approached to take part in the study. If they agree to take part, they will be enrolled in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 2728 0
New Zealand
State/province [1] 2728 0

Funding & Sponsors
Funding source category [1] 257214 0
University
Name [1] 257214 0
University of Auckland
Country [1] 257214 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Psychological Medicine
Faculty of Medical and Health Science
University of Auckland
Private Bag 92019
Auckland
1142
Country
New Zealand
Secondary sponsor category [1] 256464 0
None
Name [1] 256464 0
Address [1] 256464 0
Country [1] 256464 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259237 0
Ethics committee address [1] 259237 0
Ethics committee country [1] 259237 0
Date submitted for ethics approval [1] 259237 0
01/07/2011
Approval date [1] 259237 0
Ethics approval number [1] 259237 0

Summary
Brief summary
In New Zealand (NZ), quite a number of young people harm themselves every year. One possible reason is that some young people have problems in their lives they don’t know how to solve. RE:SOLVE is a Problem Solving Therapy (PST) programme that might help by teaching young people to problem solve more effectively. The main aim of this study is to explore whether young people and therapists find PST an acceptable and feasible approach. This is achieved through a qualitative study of the resource development, a qualitative study of the training programme, and an open trial in which 20 eligible young people will be offered RE:SOLVE PST in addition to TAU from a practitioner who had taken part in the RE:SOLVE training. The open trial will use measures of mood, hopelessness, problem solving skills, suicidal thinking and function. The qualitative aspects of the study will use questionnaires and in depth interviews.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31346 0
Address 31346 0
Country 31346 0
Phone 31346 0
Fax 31346 0
Email 31346 0
Contact person for public queries
Name 14593 0
Joanne Blackett
Address 14593 0
Department of Psychological Medicine
Faculty of Medical and Health Science
University of Auckland
Private Bag 92019
Auckland
1142
Country 14593 0
New Zealand
Phone 14593 0
+64 9 3737599 ext 86531
Fax 14593 0
Email 14593 0
[email protected]
Contact person for scientific queries
Name 5521 0
Joanne Blackett
Address 5521 0
Department of Psychological Medicine
Faculty of Medical and Health Science
University of Auckland
Private Bag 92019
Auckland
1142
Country 5521 0
New Zealand
Phone 5521 0
+64 9 3737599 ext 86531
Fax 5521 0
Email 5521 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

Documents added manually
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