Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000353796
Ethics application status
Approved
Date submitted
17/03/2013
Date registered
3/04/2013
Date last updated
5/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Facilitating training transfer of evidence-based recovery practices through values-focused interventions in a multi-site program for mental health workers.
Scientific title
A quasi-experimental investigation of the effects of values clarification and coaching versus implementation planning and coaching on the transfer of evidence-based mental health recovery practices by community based mental health workers at 6 and 12 months post intervention.
Secondary ID [1] 282104 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe and chronic mental illnesses, e.g. Bipolar Disorder, Schizophrenia, Borderline Personality Disorder.

Study participants are the mental health workers (community-based) who support individuals with aforementioned health conditions. 288599 0
Condition category
Condition code
Mental Health 288931 288931 0 0
Schizophrenia
Mental Health 288932 288932 0 0
Psychosis and personality disorders
Public Health 289085 289085 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are multiple groups comprising the intervention group, randomised within each of the partner organisations to condition by worksite. Every group randomised to the intervention group receives all of the components outlined below.
Following randomisation to condition (discussed in more detail in following sections) intervention start-dates are established for each site based on resource availability and organisational readiness. All sites are to commence Day 1 of intervention within 12 months from end 2010.


Days 1 and 2
1.Standard intervention - Collaborative Recovery Model Training Program (CRM) (Oades et al. 2006): 2 day training program that equips mental health workers with theoretical and practical skills in recovery-oriented care

Day 3 of intervention:
2. Values clarification - Survey of Life Principles (Ciarrochi & Bailey, 2010) + Principles Success Rating Sheet (adapted from Sheldon and colleagues, 1998; 1999). Participants are facilitated through a structured values clarification process using 60 cards and a structured card-sorting process. The first "sort" aides identification of top 15 values / principles of living in life generally. The participants are then facilitated through the card sort process again to identify their top 15 work values.

Days 1 - 3 are group-based face-to-face workshops.

3. Values-focused coaching via CRM protocol: 12 x 1 hr monthly coaching sessions between staff participant and assigned in-service coach. These one-on-one sessions are facilitated by in-house coaches once per month for a period of 12 months following initial training (Days 1-3). The purpose of these coaching sessions is to continue practice /training in CRM protocol and to encourage purposeful striving toward values identified by participant in Day 3 and thereafter.
Intervention code [1] 286706 0
Behaviour
Intervention code [2] 286707 0
Rehabilitation
Comparator / control treatment
There are multiple worksites in the control condition, identified via randomisation (outlines hereafter). All worksites in the control group receive all intervention components below.
Intervention start dates for each of the groups in the control condition are negotiated based on resources and availability. All groups commence within 12 month period from end 2010 and receive interventions according to the same schedule:

Implementation interventions:
Days 1 and 2:
1. Standard CRM Interventions as per experimental condition - Days 1 and 2.

Day 3:
2. Implementation planning - Facilitated workshop + structured problem solving using SWOT analysis.

Days 1 - 3 are group-based face-to-face workshops.

3. Implementation-focused coaching via CRM protocol: 12 x 1hr monthly coaching sessions between staff participant and assigned inservice coach. These are one-on-one sessions conducted face-to-face for a period of 12 months following initial training (Days 1-3). The purpose of these coaching sessions is to continue practice / training in CRM protocol and to encourage implementation of these into workplace practice by assisting participating staff to overcome barriers.
Control group
Active

Outcomes
Primary outcome [1] 289058 0
Implementation of evidence-based practice (objective):
Examples of newly acquired skills in work participant files.
Methods: GAP-IQ (Clarke et al., 2009)
Timepoint [1] 289058 0
6-0 months pre intervention, 0-6 months post intervention, 6-12 months post intervention
Primary outcome [2] 289059 0
Implementation of evidence-based practice (self report)
CRM-VQ (adapted from Sheldon & Kasser,1998; Sheldon & Elliott, 1999)
- measure of purposeful striving toward specified workplace implementation goals
-measure of autonomous vs controlled motivation for workplace change
-measure of plans to implement specific workplace goals
Timepoint [2] 289059 0
Pre training, post training, 6mth follow-up, 12mth follow-up
Secondary outcome [1] 301654 0
Participant (mental health worker) wellbeing:
-Psychological Wellbeing Scale (PWB; Ryff 1989)
-General Health Questionnaire (GHQ; Goldberg, 1978)
-Maslach Burnout Inventory (MBI; Maslach & Jackson, 1981)
Timepoint [1] 301654 0
pre, post, 6mth, 12mth
Secondary outcome [2] 301655 0
Recovery Knowledge and attitude:
Recovery Knowledge Inventory (RKI; Bedregal et al., 2005)
Staff Attitude to Recovery (STARS; Crowe et al., 2006)
Timepoint [2] 301655 0
Pre, post, 6mth, 12mth

Eligibility
Key inclusion criteria
1. Mental Health worker employed within site randomised to experimental or control condition
2. No prior formal experience in CRM
3. Consent to participant in research process
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Not working within randomised site
2. Participated in CRM training prior to study

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participating organisations will nominate an even number of total sites from across their organisation based on capacity and feasibility.
Each site will be randomly allocated to either experimental (values) or control (implementation) using a computerised random number generator which also allocation concealment. Equal numbers of sites will be allocated to each condition within individual organisations.

Cluster-randomisation has been adopted (as opposed to single-subject randomisation) to maximise fidelity to condition and foster feasibility / utility for partner organisations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects are allocated to condition by work site (i.e. cluster-randomisation). A computerised random-number generator will be used to allocate worksites to either the experimental (values) or control (implementation) condition.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Simple correlations will be used to explore direction and strength of relationships between experimental variables. Factor analysis will be used to test assumptions and advance models relating to autonomous motivation for change that is imposed. Two way analysis of variance will be used to investigate the effect of condition and time on main outcome variables (e.g. transfer, self-reported uptake) and other variables of interest at various time points.


Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2009
Actual
1/10/2009
Date of last participant enrolment
Anticipated
1/04/2012
Actual
1/04/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 286893 0
Government body
Name [1] 286893 0
Australian Research Council - New Projects Linkage Grant
No. LP 0990708
Country [1] 286893 0
Australia
Funding source category [2] 286895 0
University
Name [2] 286895 0
School of Psychology / Illawarra Institute for Mental Health
University of Wollongong
Country [2] 286895 0
Australia
Funding source category [3] 286993 0
Other
Name [3] 286993 0
SNAP Gippsland
Country [3] 286993 0
Australia
Funding source category [4] 286994 0
Other
Name [4] 286994 0
Neami
Country [4] 286994 0
Australia
Funding source category [5] 286995 0
Other
Name [5] 286995 0
Aftercare
Country [5] 286995 0
Australia
Funding source category [6] 286996 0
Other
Name [6] 286996 0
Richmond Fellowship Queensland
Country [6] 286996 0
Australia
Funding source category [7] 286997 0
Other
Name [7] 286997 0
Mission Australia
Country [7] 286997 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
School of Psychology / Illawarra Institute for Mental Health
Building 22
Wollongong Campus
Northfields Avenue
Gwynneville NSW 2500
Country
Australia
Secondary sponsor category [1] 285680 0
None
Name [1] 285680 0
Address [1] 285680 0
Country [1] 285680 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288955 0
University of Wollongong - Human Research Ethics Committee
Ethics committee address [1] 288955 0
Ethics committee country [1] 288955 0
Australia
Date submitted for ethics approval [1] 288955 0
Approval date [1] 288955 0
28/08/2009
Ethics approval number [1] 288955 0
HE09/221

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

Contacts
Principal investigator
Name 38406 0
Prof Frank P Deane
Address 38406 0
Illawarra Institute for Mental Health
Building 22
University of Wollongong
Northfields Avenue
Gwynneville NSW 2500
Country 38406 0
Australia
Phone 38406 0
+61 02 4221 3747
Fax 38406 0
Email 38406 0
[email protected]
Contact person for public queries
Name 38407 0
Virginia Williams
Address 38407 0
iiMH / Northfields Clinic
Building 22
University of Wollongong
Northfields Avenue
Gwynneville NSW 2500
Country 38407 0
Australia
Phone 38407 0
+61 02 42413747
Fax 38407 0
Email 38407 0
[email protected]
Contact person for scientific queries
Name 38408 0
Virginia Williams
Address 38408 0
iiMH/ Northfields Clinic
Building 22
University of Wollongong
Northfields Avenue
Gwynneville NSW 2500
Country 38408 0
Australia
Phone 38408 0
+61 02 4221 3747
Fax 38408 0
Email 38408 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImproving implementation of evidence-based practice in mental health service delivery: protocol for a cluster randomised quasi-experimental investigation of staff-focused values interventions.2013https://dx.doi.org/10.1186/1748-5908-8-75
EmbaseA cluster-randomised controlled trial of values-based training to promote autonomously held recovery values in mental health workers.2016https://dx.doi.org/10.1186/s13012-015-0363-5
N.B. These documents automatically identified may not have been verified by the study sponsor.