Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000501549
Ethics application status
Approved
Date submitted
5/01/2015
Date registered
19/05/2015
Date last updated
19/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Ripple Project: Improving the mental health of young people in out of home care.
Scientific title
Mixed-methods cross-sectional, experimental study to evaluate the effect of a tailored mental health intervention on mental health, resilience and social function in young people in out of home care (OoHC).
Secondary ID [1] 285910 0
none
Universal Trial Number (UTN)
Trial acronym
Ripple
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 293831 0
Condition category
Condition code
Mental Health 294132 294132 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A tailored mental health intervention that enhances the care roles and capacities of carers in out of home care in the northern and western metropolitan regions of Melbourne.
The intervention involves specialist mental health practitioners working with case managers and CSOs to incorporate evidence-based practice (EBP) elements into work processes. The EBP elements will be drawn from empirically supported treatments (ESTs) including motivational interviewing (MI), cognitive-behavioural therapy (CBT) and the adolescent community reinforcement approach (ACRA).
The methods used by the mental health practitioners for sustainable knowledge and skills transfer include training, co-working to improve confidence and skills, embedding a clinician, mentoring and feedback at individual and organisational levels, mental health consultation and group work.
The intervention will be delivered over a period of two years on a fortnightly basis. The intervention will be delivered face-to-face to staff groups, or when secondary consultation is requested, one-to-one sessions with individual staff members. Group sessions will run for one to two hours. Individual sessions will run for one hour. Process evaluation will be conducted to monitor implementation of the intervention. This will include record keeping by mental health practitioners, six-monthly quantitative assessments with participants and annual focus groups and interviews to assess acceptability of the intervention.
Intervention code [1] 290888 0
Behaviour
Comparator / control treatment
Young people receiving care as usual in the southern and eastern metropolitan regions of Melbourne. Each CSO has individual arrangements for training and professional development of carers and case managers, which can include mental health education. These arrangements will be monitored to assess levels of care that constitute 'care as usual' in each CSO and compared to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 293935 0
Mental health, as measured by the K10 and Strengths and Difficulties Questionnaire (SDQ).
Timepoint [1] 293935 0
3 years post baseline
Primary outcome [2] 294256 0
Social function - as measured by the Friendship Scale,
Timepoint [2] 294256 0
3 years post baseline
Primary outcome [3] 294257 0
Quality of life - as measured by the Child Health Utility Scale (CHU9D)
Timepoint [3] 294257 0
3 years post baseline
Secondary outcome [1] 312173 0
number of placement changes as measured by validated demographic questions by individual interview
Timepoint [1] 312173 0
3 years post baseline
Secondary outcome [2] 312890 0
Residential care workers (carers) satisfaction with their work as measured by the Organisational Learning Capacity Scale (OLCS)
Timepoint [2] 312890 0
3 years post baseline
Secondary outcome [3] 312891 0
Foster parents and kinship carers' (carers) community connections and sense of empowerment as measured by the Carer Users Expectations Scale (CUES). This is a composite secondary outcome.
Timepoint [3] 312891 0
3 years post baseline
Secondary outcome [4] 313289 0
Harmful use of substances (additional primary outcome) as measured by the ASSIST-Y
Timepoint [4] 313289 0
3 years post baseline
Secondary outcome [5] 313290 0
community service organisation (CSO) workers' (care coordinators) satisfaction with their work as measured by the Organisational Learning Capacity Scale (OLCS)
Timepoint [5] 313290 0
3 years post baseline

Eligibility
Key inclusion criteria
Young people receiving OoHC from participating Community Service Organisations. Carers and case managers providing support for young people in OoHC
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lack of cognitive capacity to complete interviews. Not currently receiving (for young people) or providing OoHC support (for carers and case managers) through participating CSO.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sample not randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study is open and non-randomised. The intervention is tailored to meet the needs/requirements of the organisation after initial assessment at baseline/immediately prior to baseline.

Geographical assignment to care as usual (southern and eastern metropolitan regions) versus treatment (northern and western metropolitan regions)
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations were conducted using IBM (registered trademark) SPSS (registered trademark) Sample Power (registered trademark) Release 3.0.1. Alpha (a) was set at the 0.05 level. Given the lack of EBP research in OoHC, it is difficult to base sample size calculations on a priori measures of effect size. However, with the numbers of young people expected in the intervention and control groups, and across the two time points (a total of 800), we would have 81% power to detect small effects (f=0.10) for main effects as well as the interaction between group and assessment occasion. With 280 carers recruited we will have 80% power to detect small-to-moderate effects (f=.20) for main effects and the interaction. To determine group differences over time on the proximal and distal outcome measures, a range of statistical techniques will be adopted. For categorical outcome measures, test statistics such as chi-square analysis, loglinear analysis, and logistic regression will be used. For continuous outcome measures, general linear models will be adopted.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/02/2015
Actual
2/02/2015
Date of last participant enrolment
Anticipated
29/09/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 9082 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 290493 0
Government body
Name [1] 290493 0
National Health and Medical Research Council
Country [1] 290493 0
Australia
Primary sponsor type
University
Name
University of Melbourne, Centre for Youth Mental Health
Address
Locked bag 10, 35 Poplar Road Parkville Victoria 3052
Country
Australia
Secondary sponsor category [1] 289191 0
Other Collaborative groups
Name [1] 289191 0
Orygen, The National Centre of Excellence in Youth Mental Health
Address [1] 289191 0
Locked bag 10, 35 Poplar Road Parkville Victoria 3052
Country [1] 289191 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292148 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 292148 0
Ethics committee country [1] 292148 0
Australia
Date submitted for ethics approval [1] 292148 0
20/12/2013
Approval date [1] 292148 0
20/02/2014
Ethics approval number [1] 292148 0
1340674
Ethics committee name [2] 292149 0
Deakin University
Ethics committee address [2] 292149 0
Ethics committee country [2] 292149 0
Australia
Date submitted for ethics approval [2] 292149 0
10/01/2014
Approval date [2] 292149 0
10/03/2014
Ethics approval number [2] 292149 0
2014.046
Ethics committee name [3] 292150 0
Department of Health
Ethics committee address [3] 292150 0
Ethics committee country [3] 292150 0
Australia
Date submitted for ethics approval [3] 292150 0
29/01/2014
Approval date [3] 292150 0
29/04/2014
Ethics approval number [3] 292150 0
14/2014
Ethics committee name [4] 292151 0
Anglicare Victoria
Ethics committee address [4] 292151 0
Ethics committee country [4] 292151 0
Australia
Date submitted for ethics approval [4] 292151 0
15/01/2014
Approval date [4] 292151 0
15/04/2014
Ethics approval number [4] 292151 0
2014-02

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44022 0
Prof Helen Herrman
Address 44022 0
Orygen, The National Centre of Excellence in Youth Mental Health
Locked bag 10, 35 Poplar Road Parkville 3052
Country 44022 0
Australia
Phone 44022 0
61 3 8387 2777
Fax 44022 0
Email 44022 0
[email protected]
Contact person for public queries
Name 44023 0
Kristen Moeller-Saxone
Address 44023 0
Orygen, The National Centre of Excellence in Youth Mental Health
Locked bag 10, 35 Poplar Road Parkville 3052
Country 44023 0
Australia
Phone 44023 0
61 3 8387 2777
Fax 44023 0
Email 44023 0
[email protected]
Contact person for scientific queries
Name 44024 0
Kristen Moeller-Saxone
Address 44024 0
Orygen, The National Centre of Excellence in Youth Mental Health
Locked bag 10, 35 Poplar Road Parkville 3052
Country 44024 0
Australia
Phone 44024 0
61 3 8387 2777
Fax 44024 0
Email 44024 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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Documents added automatically
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