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Trial registered on ANZCTR


Registration number
ACTRN12619000580178
Ethics application status
Approved
Date submitted
28/02/2019
Date registered
15/04/2019
Date last updated
15/04/2019
Date data sharing statement initially provided
15/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving mental health screening for Aboriginal and Torres Strait Islander pregnant women and mothers of young children
Scientific title
Improving mental health screening for Aboriginal and Torres Strait Islander pregnant women and mothers of young children
Secondary ID [1] 297379 0
NHMRC APP1132659
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal mental health 311530 0
Condition category
Condition code
Mental Health 310166 310166 0 0
Depression
Mental Health 310167 310167 0 0
Anxiety
Reproductive Health and Childbirth 310474 310474 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the Pilbara/Far North Queensland, the intervention is administration of the Kimberley Mum's Mood Scale (KMMS). Trained perinatal health care providers will administer the KMMS (up to 60 minutes to complete part 1 and part 2), face-to-face, in a culturally safe space. The KMMS will be used instead of the EPDS; current EPDS guidelines are twice in the antenatal (early in pregnancy and 28 or 36 weeks) and three times in the postnatal (8 weeks, 4 and 12 months) period or any other time where there is parental or professional concern. All women with moderate or high risk and up to half of women with low risk of anxiety or depression on the KMMS will be referred for a reference standard assessment using the KMMS diagnosis and management tool. This will be done face-to-face by appropriate clinical experts (e.g. GP, clinical psychologist) and take 15-30 minutes. Diagnosis will be according to DSM IV criteria for anxiety and depressive disorders, and severity (low, moderate, high) based on the GP Mental State Examination.

In the Kimberley it is routine practice for all Aboriginal women to be screened with the KMMS and for those who score 'moderate' or 'high' to be referred for further clinical assessment using the KMMS diagnosis and management tool. The intervention part of the study in the Kimberley is for up to half of women who scored 'low 'on the KMMS to be referred for a reference standard assessment using the KMMS diagnosis and management tool. As this is a real world implementation study women at low KMMS risk will be referred for further assessment when resources are available. This will be done face-to-face by clinical experts (e.g. GP, clinical psychologist) and take 15-30 minutes. Diagnosis will be according to DSM IV criteria for anxiety and depressive disorders, and severity (low, moderate, high) based on the GP Mental State Examination. Completed KMMS assessment and diagnosis forms as well as extracted primary health care data will be used to monitor adherence.

Based upon feedback provided from users (including both women and clinicians) elements of the KMMS and KMMS diagnosis and management tools and training manuals may be adapted, including the terminology, language used, and elements discussed.
Intervention code [1] 313637 0
Early detection / Screening
Comparator / control treatment
In the Kimberley, it is routine practice for all Aboriginal women to be screened with the KMMS. Trained perinatal health care providers will administer the KMMS (up to 60 minutes to complete part 1 and part 2), face-to-face, in a culturally safe space. The current guidelines are twice in the antenatal (early in pregnancy and 28 or 36 weeks) and three times in the postnatal (8 weeks, 4 and 12 months) period or any other time where there is parental or professional concern.

In the Kimberley, it is routine practice for all women with moderate or high risk of anxiety or depression on the KMMS to be referred for a reference standard assessment using the KMMS diagnosis and management tool. This will be done face-to-face by appropriate clinical experts (e.g. GP, clinical psychologist) and take 15-30 minutes. Diagnosis will be according to DSM IV criteria for anxiety and depressive disorders, and severity (low, moderate, high) based on the GP Mental State Examination. During the study clinical experts will be trained to use the KMMS diagnosis and management tool.

Implementation of the KMMS and follow-up screening will be observed as part of this study and data from this arm of the study will be combined with the "intervention" data from all three regions to determine the effectiveness of KMMS as a screening tool in the real world. Completed KMMS assessment and diagnosis forms as well as extracted primary health care data will be used to monitor adherence.

Based upon feedback provided from users (including both women and clinicians) elements of the KMMS and KMMS diagnosis and management tools and training manuals may be adapted, including the terminology, language used, and elements discussed.
Control group
Active

Outcomes
Primary outcome [1] 319052 0
Sensitivity of the KMMS for screening for perinatal anxiety and depression will be assessed using the KMMS diagnosis and management tool (involving both the DSM IV and GP Mental State Examination). Outcome will be assessed using the number of those diagnosed with anxiety and/or depression confirmed with the KMMS diagnosis and management tool.
Timepoint [1] 319052 0
Assessment using KMMS diagnosis and management tool are to be completed within 7 days of the KMMS
Primary outcome [2] 319737 0
Acceptibility: directly following KMMS administration participants will be asked to complete an anonymous short questionnaire about their experience. We will also invite participants to undertake depth evaluation of the KMMS via semi structured interviews.

Ongoing consultation will continue to take place across the Kimberley with Kimberley Aboriginal women to ensure that the lessons learnt during the implementation project and potential modifications to the KMMS are in accordance with community expectation. The primary difference being that these participants may not have been encountered the KMMS in a clinical setting. These women might be grandmothers, mothers of older children or women who do not have children.
Timepoint [2] 319737 0
Throughout the project.
Secondary outcome [1] 366830 0
Health system responses to identified risk. This will be assessed using primary health care data.
Timepoint [1] 366830 0
Within 72 hours of the intervention for those at high risk, 7 days for those at moderate risk and within 7 days for those at low risk who are referred for a reference standard assessment.
Secondary outcome [2] 366831 0
Pattern of change in KMMS risk. Outcome will be assessed using the KMMS.
Timepoint [2] 366831 0
At recruitment during the antenatal period and within 12 months after giving birth

Eligibility
Key inclusion criteria
Women who identify as Aboriginal and/or Torres Strait Islander, able to provide informed consent and either more than 7 days post-partum or more than 6 weeks pregnant who are not known to be currently acutely mentally unwell are eligible to be enrolled in the study.
Minimum age
16 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Diagnosis
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 assessing the outcomes
Intervention assignment
Other
Other design features
One group is receiving the KMMS as an intervention as part of this study, the other arm is using the KMMS as part of standard practice.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The size of the sample needed depends on the precision of sensitivity required for screening for perinatal anxiety and depression (main analysis). We plan to recruit an equal number of antenatal and postnatal women. Mental health prior to pregnancy is an important predictor of perinatal wellbeing, and in the pilot study there was no significant difference in KMMS risk levels or reference standard assessments between antenatal and postnatal participants. Data from antenatal and postnatal women in the current study will be pooled for the main analysis. If there are no significant differences between the data from the three regions these data will also be pooled.

Assuming there is a minimum sensitivity of 83% for screening for perinatal anxiety and depression and prevalence is at least 25% (based on the pilot study), using calculations by Buderer a sample size of 868 paired KMMS / reference standard assessments will detect a two-tailed 95% Cl with a maximum width of ±5% (i.e., if sensitivity 83%, 95% Cl 78-88 %). This is towards the upper end of reported sensitivities for the EPDS compared to a reference standard assessment (59%-100 %).

Based on data from the pilot study we expect 65% of participants completing a KMMS assessment will be referred for the reference standard assessment and that at least 75% of those who are referred will have both the KMMS and reference standard assessments completed (i.e., require 1780 KMMS to obtain 868 paired assessments). For the secondary analysis to determine changes in KMMS risk we aim to assess as many participants as possible both antenatally and postnatally. As a conservative estimate we will assume that at least 60% of participants will have KMMS administered at both time points. Recruiting 890 antenatal women (50% of the 1780 KMMS required) should provide at least 534 paired antenatal/postnatal KMMS assessments. In addition approximately 356 women will be recruited postnatally to ensure that we have 890 antenatal and 890 postnatal KMMS assessments required for the main sample size calculation.

Therefore, we aim to recruit 1246 women (890 in the antenatal period and 356 women postnatally) over 3 years to provide 868 paired KMMS / reference standard assessments using the KMMS diagnosis and management tool and 534 paired antenatal/ postnatal KMMS assessments.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 13121 0
Kununurra Hospital - Kununurra
Recruitment hospital [2] 13122 0
Aurukun Primary Health Care Centre - Aurukun
Recruitment hospital [3] 13123 0
Coen Primary Health Care Centre - Coen
Recruitment hospital [4] 13124 0
Kowanyama Primary Health Care Centre - Kowanyama
Recruitment hospital [5] 13125 0
Lockhart & District Hospital - Lockhart
Recruitment hospital [6] 13126 0
Pormpuraaw Primary Health Care Centre - Pormpuraaw
Recruitment hospital [7] 13127 0
Mossman Hospital (Douglas Shire Multi Purpose Health Service) - Mossman
Recruitment hospital [8] 13128 0
Mapoon Primary Health Care Centre - Mapoon
Recruitment hospital [9] 13129 0
Hedland Health Campus - South Hedland
Recruitment hospital [10] 13130 0
Derby Hospital - Derby
Recruitment postcode(s) [1] 25638 0
4870 - Cairns
Recruitment postcode(s) [2] 25639 0
4871 - Aurukun
Recruitment postcode(s) [3] 25640 0
4871 - Coen
Recruitment postcode(s) [4] 25641 0
4871 - Kowanyama
Recruitment postcode(s) [5] 25642 0
4871 - Lockhart
Recruitment postcode(s) [6] 25643 0
4871 - Pormpuraaw
Recruitment postcode(s) [7] 25644 0
4871 - Yarrabah
Recruitment postcode(s) [8] 25645 0
4873 - Mossman
Recruitment postcode(s) [9] 25646 0
4874 - Mapoon
Recruitment postcode(s) [10] 25647 0
6714 - Karratha
Recruitment postcode(s) [11] 25648 0
6718 - Roebourne
Recruitment postcode(s) [12] 25649 0
6720 - Cossack
Recruitment postcode(s) [13] 25650 0
6720 - Point Samson
Recruitment postcode(s) [14] 25651 0
6720 - Wickham
Recruitment postcode(s) [15] 25652 0
6721 - Port Hedland
Recruitment postcode(s) [16] 25653 0
6722 - South Hedland
Recruitment postcode(s) [17] 25654 0
6725 - Broome
Recruitment postcode(s) [18] 25655 0
6725 - Dampier Peninsula
Recruitment postcode(s) [19] 25656 0
6726 - Cable Beach
Recruitment postcode(s) [20] 25657 0
6728 - Derby
Recruitment postcode(s) [21] 25658 0
6740 - Kalumburu
Recruitment postcode(s) [22] 25659 0
6740 - Wyndham
Recruitment postcode(s) [23] 25660 0
6743 - Gibb
Recruitment postcode(s) [24] 25661 0
6743 - Kununurra
Recruitment postcode(s) [25] 25663 0
6743 - Warmun
Recruitment postcode(s) [26] 25664 0
6751 - Tom Price
Recruitment postcode(s) [27] 25665 0
6753 - Newman
Recruitment postcode(s) [28] 25666 0
6754 - Paraburdoo
Recruitment postcode(s) [29] 25667 0
6758 - Nullagine
Recruitment postcode(s) [30] 25668 0
6760 - Marble Bar
Recruitment postcode(s) [31] 25669 0
6765 - Fitzroy Crossing
Recruitment postcode(s) [32] 25670 0
6770 - Halls Creek
Recruitment postcode(s) [33] 25671 0
6770 - Tanami

Funding & Sponsors
Funding source category [1] 301949 0
Government body
Name [1] 301949 0
National Health and Medical Research Council (NHMRC)
Address [1] 301949 0
Level 5, 20 Allara street, Canberra City, ACT 2600
Country [1] 301949 0
Australia
Funding source category [2] 301961 0
Government body
Name [2] 301961 0
Government of Western Australia, Department of Health
Address [2] 301961 0
Level 2
C Block
189 Royal Street
East Perth WA 6004
Country [2] 301961 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Highway
CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 301721 0
None
Name [1] 301721 0
Address [1] 301721 0
Country [1] 301721 0
Other collaborator category [1] 280554 0
Commercial sector/Industry
Name [1] 280554 0
Kimberley Aboriginal Medical Services
Address [1] 280554 0
PO Box 1377
Broome WA 6725
Country [1] 280554 0
Australia
Other collaborator category [2] 280555 0
Commercial sector/Industry
Name [2] 280555 0
Health Department of Western Australia
Address [2] 280555 0
Level 2, C Block,
189 Royal Street,
East Perth WA 6004
Country [2] 280555 0
Australia
Other collaborator category [3] 280556 0
Commercial sector/Industry
Name [3] 280556 0
Apunipima Cape York Health Council
Address [3] 280556 0
186 McCoombe Street
Bungalow QLD 4870
Country [3] 280556 0
Australia
Other collaborator category [4] 280578 0
Commercial sector/Industry
Name [4] 280578 0
Mawarnkarra Health Service
Address [4] 280578 0
20 Sholl St
Roebourne WA 6718
Country [4] 280578 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302630 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [1] 302630 0
450 Beaufort Street
Highgate WA 6003
Ethics committee country [1] 302630 0
Australia
Date submitted for ethics approval [1] 302630 0
18/05/2017
Approval date [1] 302630 0
09/06/2017
Ethics approval number [1] 302630 0
781
Ethics committee name [2] 302643 0
WA Country Health Service Human Research Ethics Committee
Ethics committee address [2] 302643 0
WA Country Health Service
Lv 7/1 Adelaide Terrace
EAST PERTH WA 6004
Ethics committee country [2] 302643 0
Australia
Date submitted for ethics approval [2] 302643 0
24/07/2017
Approval date [2] 302643 0
10/08/2017
Ethics approval number [2] 302643 0
RGS 206
Ethics committee name [3] 302646 0
James Cook University HREC
Ethics committee address [3] 302646 0
Research Services,
Room 301 The Science Place Building 142
James Cook University
Townsville Qld 4811
Ethics committee country [3] 302646 0
Australia
Date submitted for ethics approval [3] 302646 0
10/11/2017
Approval date [3] 302646 0
22/12/2017
Ethics approval number [3] 302646 0
H7232

Summary
Brief summary
Mental health during and after pregnancy is important for the well-being of mother and infant. Perinatal depression and anxiety are common problems, particularly for Aboriginal and Torres Strait Islander women, and can have significant short and long-term impacts on both mother and child. Aboriginal and Torres Strait Islander women in remote areas are at particular risk and the available screening instrument, the Edinburgh Postnatal Depression Scale is not seen as appropriate for this population.

The locally developed, validated, culturally appropriate and user friendly KMMS was developed to accurately assess risk of anxiety and depression, improve screening rates and help provide better care for Aboriginal women during the perinatal period. The KMMS has been piloted on 91 women in the Kimberley. It was found to be an effective screening instrument for anxiety and depression in Aboriginal perinatal women, improved relationships between health care providers and their patients, and was a useful tool for providing psycho social support and, where necessary developing pathways for specialised mental health/social and emotional wellbeing follow up. The KMMS is accepted for use across the Kimberley and is included in regional guidelines. The KMMS has not been fully evaluated in a real world setting and has not been trialed in other remote settings. In partnership with health services and Aboriginal communities in northern Western Australia and Far North Queensland, this study aims to:
* adapt the KMMS and develop locally appropriate versions for participating partners as required;
* evaluate the real-world performance of the KMMS in the Kimberley and other remote regions in northern Australia; and
* evaluate the process of implementation.
Trial website
http://kams.org.au/research/current-projects/
Trial related presentations / publications
Public notes
Prior to registration of this study as a clinical trial, recruitment for the adaptation of the KMMS in FNQ and Pilbara has taken place. In the Kimberley, women were recruited to further assess user acceptability of the KMMS and seven women were involved in piloting the Kimberley observational arm of the study. Recruitment into the intervention arm of the study in all regions will commence after trial registration.

Contacts
Principal investigator
Name 90878 0
A/Prof Julia Marley
Address 90878 0
The Rural Clinical School of Western Australia
The University of Western Australia
PO Box 1377
Broome WA 6725
Country 90878 0
Australia
Phone 90878 0
+61 8 9194 3235
Fax 90878 0
Email 90878 0
julia.marley@rcswa.edu.au
Contact person for public queries
Name 90879 0
Ms Emma Carlin
Address 90879 0
The Rural Clinical School of Western Australia
The University of Western Australia
PO Box 1377
Broome WA 6725
Country 90879 0
Australia
Phone 90879 0
+61 8 9194 3235
Fax 90879 0
Email 90879 0
emma.carlin@rcswa.edu.au
Contact person for scientific queries
Name 90880 0
A/Prof Julia Marley
Address 90880 0
The Rural Clinical School of Western Australia
The University of Western Australia
PO Box 1377
Broome WA 6725
Country 90880 0
Australia
Phone 90880 0
+61 8 9194 3235
Fax 90880 0
Email 90880 0
julia.marley@rcswa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the ethical restrictions involved in working with Aboriginal communities, the minimal dataset will be made available upon request.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Clinical study report
Summary results
No Results