Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000653763p
Ethics application status
Submitted, not yet approved
Date submitted
24/03/2022
Date registered
4/05/2022
Date last updated
4/05/2022
Date data sharing statement initially provided
4/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study on the effect of career interventions on health outcomes for unemployed or underemployed Maori adults
Scientific title
Pilot study: The effect of targeted career interventions on health outcomes in unemployed and underemployed Maori patients incorporating the Meihana Model
Secondary ID [1] 306752 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 325849 0
Depression 325850 0
Diabetes 325851 0
Obesity 325852 0
Condition category
Condition code
Public Health 323099 323099 0 0
Other public health
Mental Health 323240 323240 0 0
Anxiety
Mental Health 323241 323241 0 0
Depression
Diet and Nutrition 323242 323242 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undertake targeted career development intervention delivered by two career development specialists, one of whom is Maori, over a period of 4-8 weeks.
The career development practice will be approached through a constructivist paradigm –where practitioners are open to multiple worldviews and are cognizant that there are more than one version of reality. The constructivist paradigm allows for different cultures and contexts to be imbued into the career development practice and compels practitioners to explore the meanings and experiences of concepts of career through a cultural lens. Practitioners will draw on tikanga and Maori values to guide and influence each session while establishing a relational environment where clients feel they are important. The service will be delivered in English, and participants will be informed of this in advance. The semi structured nature of the career development sessions will be influenced by Durie’s 3 E’s Model (Whakapiri, Whakamarama, Whakamana). Our practice will encompass Te Whare Tapa Wha and will be influenced by career theories such Amundson’s Active Engagement Model, Savickas’ Life Design, Krumboltz’s Social Learning Theory, Bright’s Chaos Career Theory, and Holland’s theory of Vocational Typology.
Career development sessions will be delivered in a mixed modality format. There will be a mixture of group activities, one on one and remote consultations. The sessions will start and finish with a group hui (meeting), korero (conversation) and karakia (prayer).
There will be five career interventions delivered across a 4-8 week period by two career practitioners at a culturally appropriate site e.g. Nga Miro Health Centre and/or a marae.
Adherence will be monitored by an attendance record, and kaiawhina/wraparound services will be supplied by Raukura Hauora o Tainui to help with issues of access/transport/attendance.

Breakdown of Sessions
Career development sessions will be delivered in a mixed modality format. There will be a mixture of group activities, one on one and remote consultations. The sessions will start and finish with a group hui, korero and karakia. The expected duration of the sessions will be 2-3 hours for the initial and final hui, and 1 hour for each of the three individual sessions.

Introductory Group Session
Kai (food) will be shared and a group hui will be conducted to introduce career practitioners to the participants and whanau, and to introduce the concepts of career development. Many of the participants and whanau may not be familiar with career development and it is crucial that participants and whanau have a clear understanding of the activities undertaken in career development sessions and what the expected outcomes may be. Participants and their whanau will have the opportunity to ask questions.

Individual Sessions
Session 1
The first individual session will be conducted by both Hana and Claire. In this session, practice will be influenced mainly by Savickas Life Design theory and Krumboltz Social learning theory. Participants will be encouraged to explore the concepts of career and work through storytelling and exploration of experiences. An introduction to the concept of gas and goal setting take place and an exploration of values and principles.

Session 2
Hana will facilitate the second session. Throughout this session, there will be a focus on skills and interests. Using such career models such as Hollands’ Theory of Career choice and exploration of past roles and skills developed through these will enable the participant to create an understanding of their own unique set of skills and interest and gain a greater understanding of how these relate to the world of work.

Session 3
Claire will facilitate this session. The focus on this session will draw mainly on Krumboltz's Learning Theory and Bright’s Chaos theory of careers. The focus will be on taking practical steps to explore career possibilities and opportunity awareness. The practitioner’s main role in this session will be to assist the participants in creating an action plan for their career and equipping them with the necessary tools to access resources required.

Final Group Session
The final group hui will be facilitated by Claire and Hana. This will be an opportunity to reflect on learnings throughout the career development process. Assess the process and whether participant objectives were achieved. It will be a shared learning and reflection process where participants evaluate their perceptions and expectations of both the world of work and the career development process both prior to and after the interventions. There will be an opportunity for participants to consolidate their learning and reflections and hopefully share their achievements with the wider whanau.
Intervention code [1] 323200 0
Behaviour
Comparator / control treatment
No control group (this is a small low-power pilot study)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330866 0
Change in mood/depression as measured by PHQ-9 score
Timepoint [1] 330866 0
0, 3, 6 (primary endpoint), 9 months relative to the first intervention
Primary outcome [2] 330867 0
Employment status
This will simply be measured by a YES/NO question "are you in regular employment"
If the answer is YES, we will clarify whether the work is full-time (>30 hours per week) or part-time (10-30 hours per week). <10 hours per week will be considered unemployed.
Timepoint [2] 330867 0
0, 3, 6 (primary endpoint), 9 months post intervention commencement
Primary outcome [3] 330868 0
Retrospective post-then-pre questionnaire of mental wellbeing as designed by Dave Redekopp and Michael Huston. This will be validated specifically for Maori by using experts in Maori career development to modify and refine the questionnaire
Timepoint [3] 330868 0
Immediately post-intervention completion
Secondary outcome [1] 407878 0
Spiritual health, measured by qualitative data through semi-formal interviews and questionnaire - the questionnaire is still to be designed through consultation with kaumatua (Maori elders). We are undertaking peer review with Maori kaumatua at the moment.
Timepoint [1] 407878 0
0, 3, 6, 9 months post-intervention commencement
Secondary outcome [2] 408080 0
Scalability of intervention. This will be assessed via semi-structured interview with the career interventionalists to evaluate the practical aspects of delivering their service to the participant group, with an evaluation of costs and other challenges. The intent is to establish feasibiity of scaling up to a power study with 800+ participants.
Timepoint [2] 408080 0
6 months post intervention commencement
Secondary outcome [3] 408081 0
Cost of intervention - audit of study financial records
Timepoint [3] 408081 0
6 months post-intervention commencement
Secondary outcome [4] 408082 0
A semi-structured interview with career interventionalists and a follow-up survey of any participants who dropped out/missed appointments will be used to explore the feasibility of expanding this into a larger power study. We will evaluate challenges faced such as participant non-attendance, drop-out rates, and barriers to access.
Timepoint [4] 408082 0
6 months post-intervention commencement
Secondary outcome [5] 408366 0
Blood pressure - measured with sphygmanometer
Timepoint [5] 408366 0
0, 3, 6, and 9 months post-intervention commencement
Secondary outcome [6] 408367 0
Diabetes - HbA1c blood test
Timepoint [6] 408367 0
0, 3, 6, 9 months post-intervention commencement
Secondary outcome [7] 408368 0
Smoking status assessed using the Smoking Behavior Research Questionnaire
Timepoint [7] 408368 0
0, 3, 6, 9 months post-intervention commencement
Secondary outcome [8] 408369 0
Height - measured on a scale
Timepoint [8] 408369 0
At 0 months
Secondary outcome [9] 408370 0
Weight, measured on a scale
Timepoint [9] 408370 0
0, 3, 6, 9 months post-intervention commencement
Secondary outcome [10] 408371 0
Anxiety - GAD7 scale
Timepoint [10] 408371 0
0, 3, 6, 9 months post-intervention commencement
Secondary outcome [11] 408372 0
Depression - PHQ9 questionnaire scale
Timepoint [11] 408372 0
0, 3, 6, 9 months post-intervention commencement
Secondary outcome [12] 408373 0
Lipids blood test, non-fasting
Timepoint [12] 408373 0
0, 3, 6, 9 months post-intervention commencement
Secondary outcome [13] 408374 0
Whanau health - semi-structured interview which will be agreed upon during consultation with kaumatua
Timepoint [13] 408374 0
0, 3, 6, 9 months post-intervention commencement

Eligibility
Key inclusion criteria
Underemployed (employed in less than 30 hours’ work per week) or unemployed for at least the preceding 3 months
Maori adults aged 18-65
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
On a Work and Income New Zealand supported living payment (“sickness benefit”)
Employed in a full-time capacity at any stage within the past 3 months

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Owing to the small sample size of this pilot study, we do not expect to demonstrate statistically significant results. During data analysis, accommodation will be made for confounding factors such as which participants enter employment and at what stage post-intervention this occurs. Data sets will be divided into those who enter full employment and those who remain unemployed or unemployed.
For this pilot study we will engage with a statistician to seek advice on a future power study for the career intervention and establish the types of statistical analysis that will be required. At the conclusion of this pilot, we aim to assess the scalability, cost, and feasibility of a large power study, and to establish the resources required for such an intervention. We will seek to answer the question of whether others can be trained to deliver the intervention, and at what cost, and the practicalities of delivering a targeted career intervention to several hundred people.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
1/08/2022
Actual
Date of last data collection
Anticipated
1/05/2023
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 24683 0
New Zealand
State/province [1] 24683 0
Waikato

Funding & Sponsors
Funding source category [1] 311091 0
Other
Name [1] 311091 0
Raukura Hauora o Tainui
Country [1] 311091 0
New Zealand
Primary sponsor type
Other
Name
Raukura Hauora o Tainui
Address
S102 The Base
Maahanga Drive
Te Rapa, Hamilton
Waikato 3200
NEW ZEALAND
Country
New Zealand
Secondary sponsor category [1] 312421 0
None
Name [1] 312421 0
Address [1] 312421 0
Country [1] 312421 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310625 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 310625 0
Ethics committee country [1] 310625 0
New Zealand
Date submitted for ethics approval [1] 310625 0
04/04/2022
Approval date [1] 310625 0
Ethics approval number [1] 310625 0

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

Contacts
Principal investigator
Name 118306 0
Dr Michael Oehley
Address 118306 0
Raukura Hauora o Tainui
S102 The Base
Maahanga Drive
Te Rapa, Hamilton
Waikato 3200
Country 118306 0
New Zealand
Phone 118306 0
+64220190890
Fax 118306 0
Email 118306 0
[email protected]
Contact person for public queries
Name 118307 0
Michael Oehley
Address 118307 0
Raukura Hauora o Tainui
S102 The Base
Maahanga Drive
Te Rapa, Hamilton
Waikato 3200
Country 118307 0
New Zealand
Phone 118307 0
+64220190890
Fax 118307 0
Email 118307 0
[email protected]
Contact person for scientific queries
Name 118308 0
Michael Oehley
Address 118308 0
Raukura Hauora o Tainui
S102 The Base
Maahanga Drive
Te Rapa, Hamilton
Waikato 3200
Country 118308 0
New Zealand
Phone 118308 0
+64220190890
Fax 118308 0
Email 118308 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15531Study protocol    383812-(Uploaded-24-03-2022-06-47-15)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.