Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000679189p
Ethics application status
Not yet submitted
Date submitted
6/03/2019
Date registered
7/05/2019
Date last updated
7/05/2019
Date data sharing statement initially provided
7/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Kia ora ai te Iwi - Whanau Oranga (wellbeing of the whole family): Supporting Maori with cultural-adapted psychological interventions to cope with the impact of Mate Wareware (Dementia).
Scientific title
Whanau Oranga (wellbeing of the whole family): Implementing and evaluating a culturally-adapted psychological program developed to support Maori (indigenous people of New Zealand) impacted by Dementia.
Secondary ID [1] 297808 0
Nil known
Universal Trial Number (UTN)
U1111-1229-6004
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 311893 0
Depression 311894 0
Anxiety 311895 0
Other mental health disorders 311896 0
Condition category
Condition code
Neurological 310481 310481 0 0
Dementias
Mental Health 310719 310719 0 0
Depression
Mental Health 310720 310720 0 0
Anxiety
Mental Health 310721 310721 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A culturally-adapted evidence-based psychological program will be implemented and evaluated with Maori impacted by Dementia. Participants include primary caregivers and relatives of those diagnosed with this neurodegenerative condition.
Specific interventions will include cognitive behavioural therapy (CBT) culturally adapted for Maori 'Poutama Hinetore' (Bennett, 2012), distress tolerance skills, mindfulness, and emotion regulation skills delivered within a kaupapa Maori framework incorporating tikanga Maori (Maori cultural practices) and te reo Maori (Maori language).
Physical information used will include summary notes and diagrams following sessions supporting specifically related to new skills learnt. These sessions notes will be made available online for participants also. The materials will be culturally adapted CBT thought records (Beck, 2011) and (Dialectical Behavioural Therapy (DBT) skills worksheets (Linehan, 2014). Relevant Maori proverbs (whakatauki), myths and legends will be incorporated into this content.
The intervention/therapy will be developed based upon the needs of the family and individual. This will be assessed using the Meihana model, a Maori clinical assessment tool that incorporates a holistic understanding of wellbeing. Specific therapies may include: CBT (processing grief, loss and negative emotions), DBT skills sessions, and mindfulness (including Maori modulation skills drawing upon traditional skills such as kapa haka (Maori cultural dance and song)).
The intervention will be delivered by the lead investigator who is an experienced registered clinical psychologist. She is of Maori descent and accesses both clinical and cultural supervision. A rangahau whanau (research advisory group) will also provide oversight.
The intervention will be delivered as group/family and individual sessions. This will be determined by the participants.
The intervention will be delivered fortnightly over a 4 month period. This may be extended by 1-2 months should the need arise from participants. For example, if whanau require additional support. The decision would be made by the lead clinical psychologist in consultation with clinical supervision.
The intervention will be implemented in a private environment of the participants choice. This may include their home, a marae (Maori cultural place of meeting), or an alternative space provided by the researcher.
The intervention is not intended to be a manualised treatment intervention. The intervention, like therapy, will be determined based upon the needs of the participants.
Intervention code [1] 313857 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319345 0
Understanding of Dementia (mate wareware) will be assessed using self-report measures and qualitative feedback including open-ended one-on-one interviews and focus groups.
Timepoint [1] 319345 0
The CBT session feedback form (culturally adapted for the study) will be used following each session. Opportunities to provide qualitative feedback will also be provided weekly.
Primary outcome [2] 319347 0
Emotional wellbeing will be assessed using the Depression, Anxiety, Stress Scale (DASS-21).
Timepoint [2] 319347 0
The DASS-21 measure will be utilised pre, mid-phase (2 months) and post intervention (4 months).
Primary outcome [3] 319588 0
Giving meaning to the impact Dementia (mate wareware) has on the family system following the Whanau Oranga intervention..
Timepoint [3] 319588 0
The CBT session feedback form (culturally adapted for the study) will be used following each session. Opportunities to provide qualitative feedback using open-ended one-on-one interviews and focus groups will also be provided.
Secondary outcome [1] 368682 0
Primary outcome - Participants' experience of a kaupapa Maori adapted intervention will be measured using the Hua Oranga outcomes measure and in a qualitative semi-structured interview post treatment. This will include 'what was helpful', 'unhelpful', and feelings about the intervention.
Timepoint [1] 368682 0
This will be measured post-treatment (within 2 months of the interventions completion).
Secondary outcome [2] 368804 0
Primary outcome - Holistic wellbeing will be assessed using the Hua Oranga outcomes measure (Kingi & Durie).
Timepoint [2] 368804 0
This will be measured post-treatment (within 2 months of the interventions completion).

Eligibility
Key inclusion criteria
Maori living in the Ngati Awa region (Whakatane Maori tribe in New Zealand) impacted by Dementia, that is, living with the diagnosis of dementia and/or family members who are primary care-givers.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants unable to provide informed consent, or access consent from their parent and/or guardian.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 21330 0
New Zealand
State/province [1] 21330 0
Whakatane, Bay of Plenty

Funding & Sponsors
Funding source category [1] 302162 0
Other Collaborative groups
Name [1] 302162 0
Brain Research New Zealand
Country [1] 302162 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
85 Grafton Road
Grafton 1142
Country
New Zealand
Secondary sponsor category [1] 302003 0
None
Name [1] 302003 0
Address [1] 302003 0
Country [1] 302003 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302843 0
Health and Disability Ethics Committee
Ethics committee address [1] 302843 0
Ethics committee country [1] 302843 0
New Zealand
Date submitted for ethics approval [1] 302843 0
18/05/2019
Approval date [1] 302843 0
Ethics approval number [1] 302843 0

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

Contacts
Principal investigator
Name 91582 0
Dr Julie Wharewera-Mika
Address 91582 0
School of Psychology
Science Centre
23 Symonds Street
University of Auckland
Auckland City 1010
Country 91582 0
New Zealand
Phone 91582 0
+64 211130314
Fax 91582 0
Email 91582 0
[email protected]
Contact person for public queries
Name 91583 0
Julie Wharewera-Mika
Address 91583 0
School of Psychology
Science Centre
23 Symonds Street
University of Auckland
Auckland City 1010
Country 91583 0
New Zealand
Phone 91583 0
+64 211130314
Fax 91583 0
Email 91583 0
[email protected]
Contact person for scientific queries
Name 91584 0
Julie Wharewera-Mika
Address 91584 0
School of Psychology
Science Centre
23 Symonds Street
University of Auckland
Auckland City 1010
Country 91584 0
New Zealand
Phone 91584 0
+64 211130314
Fax 91584 0
Email 91584 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
To be determined by participants.


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
No additional documents have been identified.