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Trial registered on ANZCTR


Registration number
ACTRN12613001120763
Ethics application status
Approved
Date submitted
3/10/2013
Date registered
8/10/2013
Date last updated
14/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Application of the Strengths Model of Case Management in Hong Kong Mental Health Services
Scientific title
A controlled before-and-after study on the effectiveness and impact of the Strengths Model of Case Management on people with severe psychiatric illnesses and their caseworkers
Secondary ID [1] 283145 0
none
Universal Trial Number (UTN)
Trial acronym
SMCM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
severe psychiatric disabilities 290004 0
Condition category
Condition code
Mental Health 290390 290390 0 0
Depression
Mental Health 290391 290391 0 0
Schizophrenia
Mental Health 290392 290392 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Strengths Model of Case Management (SMCM) is the intervention used in the current trial. The SMCM consists of three primary tools that are used during session between the case manager and the client. The Strengths Assessment appraises the current personal and environmental assets (strengths) of the client. The Personal Medicine Worksheet are first-person accounts of activities that give rise to purpose and meaning to the client's life; they are also believed to be activities that could counteract the symptoms that a client has. The Personal Recovery Plan, on the other hand, utilizes information from the aforementioned two assessment tools to derive a recovery plan that is meaningful for the client, and its implementation.

The intervention will consist of weekly session, each lasting for 45 to 60 minutes. This intervention model is to be run for the entire course of 6 months. A typical session consists of natural conversations between the client and the case manager. During the conversation, the case manager has a responsibility to gauge, as well as elicit contents with an underlying goal to review and revise the Strengths Assessment.

Sometimes, the caseworker will also have a conversation with the clients with an aim to create an agenda for recovery. This involves identifying elements that are meaningful for the clients in their own recovery, and assisting them to achieve the recovery goal by breaking the goal down to small, achievable steps, and monitor the progress periodically.

In addition to the actual sessions, the intervention is also characterized by adoptions of new practices in the settings, such as weekly group supervision sessions amongst teams of case workers, a lower client-to-worker ratio, and field mentoring. Adherence to these standards (i.e. safeguarding of fidelity) will be monitored through the Fidelity checklist developed by the University of Kansas. Fidelity check will be conducted at the three settings prior to commencement of the trial. The pre-requisite scores are: an average of 4 for the structural items; an average of 4 for the supervision/supervisors items; and an average score of 3.5 for the clinical/service items is set.
Intervention code [1] 287880 0
Lifestyle
Intervention code [2] 287881 0
Treatment: Other
Intervention code [3] 287882 0
Rehabilitation
Comparator / control treatment
Control participants will receive standard care provided for them in thier respective agencies. We do not dictate the control treatment, as it differ by settings. General content of standard care including regular sessions with the client, medical appointments, community activities.
Control group
Active

Outcomes
Primary outcome [1] 290411 0
Recovery of clients, measured using the Maryland Assessment of Recovery in People with Serious Mental Illness (MARS; Drapalski et al., 2012).
Timepoint [1] 290411 0
To be taken at baseline, month 3 and month 6 (endpoint).
Secondary outcome [1] 304460 0
Subjective wellbeing, or satisfaction with life, is measured using the Satisfaction with Life Scale (SWLS; Diener, Emmons, Larsen & Griffin, 1985).
Timepoint [1] 304460 0
To be taken at baseline, month 3 and month 6 (endpoint).
Secondary outcome [2] 304461 0
Psychiatric symptoms are measured with Brief Psychiatric Rating Scale (Overall & Gorham, 1962).
Timepoint [2] 304461 0
To be taken at baseline, month 3 and month 6 (endpoint).
Secondary outcome [3] 304462 0
Therapeutic alliance: The Working Alliance Inventory (WAI; (Horvath & Greenberg, 1989)) is used to measure three components of therapeutic alliance: the bond between the therapist and the client, the agreement on goals and the agreement on tasks. The client form will be used.
Timepoint [3] 304462 0
To be taken at baseline, month 3 and month 6 (endpoint).
Secondary outcome [4] 304463 0
The perceived degree to which intervention and the setting is recovery oriented is measured using the Recovery Self Assessment (RSA, O’Connell et al., 2007). The person-in-recovery form wll be used.
Timepoint [4] 304463 0
To be taken at baseline, month 3 and month 6 (endpoint).
Secondary outcome [5] 304464 0
Other outcomes such as educational / vocational outcomes, occurrence of hospitalization will be drawn from individual case records, documented periodically by the case managers. These will be measured using a questionnaire designed for this purpose.
Timepoint [5] 304464 0
To be taken at baseline, month 3, and month 6 (endpoint).
Secondary outcome [6] 304465 0
Job burnout will be measured using the The Maslach Burnout Inventory (Maslach & Jackson, 1986), the most widely used measure of burnout and has previously been used in mental health services research (Prosser et al., 1999).
Timepoint [6] 304465 0
To be taken at baseline, month 3 and month 6 (endpoint).
Secondary outcome [7] 304466 0
The Utrecht Work Engagement Scale (UWES) (Schaufeli, Bakker, & Salanova, 2006) will be used to measure work engagement.
Timepoint [7] 304466 0
To be taken at baseline, month 3 and month 6 (endpoint).
Secondary outcome [8] 304467 0
Therapeutic alliance: The Working Alliance Inventory (WAI; (Horvath & Greenberg, 1989)) is used to measure three components of therapeutic alliance: the bond between the therapist and the client, the agreement on goals and the agreement on tasks. The therapist form will be used.
Timepoint [8] 304467 0
To be taken at baseline, month 3 and month 6 (endpoint).
Secondary outcome [9] 304468 0
The perceived degree to which intervention and the setting is recovery oriented is measured using the Recovery Self Assessment (RSA, O’Connell et al., 2007). The service provider form will be used.
Timepoint [9] 304468 0
To be taken at baseline, month 3 and month 6 (endpoint).

Eligibility
Key inclusion criteria
1. At least 18 years of age
2. Consent to participation
3. Is able to read, and comprehend Chinese
4. Is currently a user of mental health services from one of the three participating NGOs
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients who are currently experience a crisis, have serious physical or mental impairments thus have difficulty participating in the research in any way, as determined by their case managers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
Assuming a small effect size (0.25) with a power of 0.8, using a 2X2 ANOVA design with one between subject factor (control vs. intervention) and one within-subject factor (pre vs. post), the minimum required sample size is 50.

Data analysis:
The objective of the data analysis is to investigate the changes, if any, between the two groups over time. Generalized linear mixed model will be used to model the correlations between repeated measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2014
Actual
Date of last participant enrolment
Anticipated
1/04/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment outside Australia
Country [1] 5387 0
Hong Kong
State/province [1] 5387 0

Funding & Sponsors
Funding source category [1] 287900 0
Self funded/Unfunded
Name [1] 287900 0
Country [1] 287900 0
Primary sponsor type
University
Name
The University of Hong Kong
Address
Department of Social Work and Social Administration, The University of Hong Kong, Pokfulam, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 286627 0
Other Collaborative groups
Name [1] 286627 0
Baptist Oi Kwan Social Services
Address [1] 286627 0
6/F, 36 Oi Kwan Road, Wanchai, Hong Kong
Country [1] 286627 0
Hong Kong
Secondary sponsor category [2] 286628 0
Other Collaborative groups
Name [2] 286628 0
Caritas (Hong Kong) Social Work Services Division
Address [2] 286628 0
Caritas Hong Kong , King Hong Home, G/F, Caritas Jockey Club Lai King Rehabilitation Centre, 31 Lai Chi Ling Road, Kwai Chung, New Territories, Hong Kong
Country [2] 286628 0
Hong Kong
Secondary sponsor category [3] 286629 0
Other Collaborative groups
Name [3] 286629 0
Tung Wah Group of Hospitals, Social Residential Services
Address [3] 286629 0
2 Wong Chuk Hang Path,
Wong Chuk Hang, Hong Kong
Country [3] 286629 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290006 0
Human Research Ethics Committee for Non-Clinical Faculties, University of Hong Kong
Ethics committee address [1] 290006 0
Ethics committee country [1] 290006 0
Hong Kong
Date submitted for ethics approval [1] 290006 0
Approval date [1] 290006 0
23/09/2013
Ethics approval number [1] 290006 0

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

Contacts
Principal investigator
Name 42694 0
Ms Tsoi Wing See Emily
Address 42694 0
Dept. of Social Work and Social Administration,
The University of Hong Kong,
Pokfulam,
Hong Kong
Country 42694 0
Hong Kong
Phone 42694 0
+85291588529
Fax 42694 0
Email 42694 0
ewstsoi@connect.hku.hk
Contact person for public queries
Name 42695 0
Tsoi Wing See Emily
Address 42695 0
Dept. of Social Work and Social Administration,
The University of Hong Kong,
Pokfulam,
Hong Kong
Country 42695 0
Hong Kong
Phone 42695 0
+85291588529
Fax 42695 0
Email 42695 0
ewstsoi@connect.hku.hk
Contact person for scientific queries
Name 42696 0
Samson Tse
Address 42696 0
Dept. of Social Work and Social Administration,
The University of Hong Kong,
Pokfulam,
Hong Kong
Country 42696 0
Hong Kong
Phone 42696 0
+85239171071
Fax 42696 0
Email 42696 0
samsont@hku.hk

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
No documents have been uploaded by study researchers.

Documents added automatically
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