Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001206617
Ethics application status
Approved
Date submitted
19/06/2023
Date registered
23/11/2023
Date last updated
23/11/2023
Date data sharing statement initially provided
23/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a new model of guided health care for young Aboriginal people to achieve better mental health and emotional wellbeing outcomes
Scientific title
Impact of a primary care health assessment and guided service navigation on Aboriginal youth mental health and wellbeing outcomes: an individually randomised controlled trial
Secondary ID [1] 308863 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 328849 0
Psychological distress 328850 0
Condition category
Condition code
Mental Health 325847 325847 0 0
Depression
Mental Health 325848 325848 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study arm (also known as Program 1) involves guided care though an Outreach Service Navigator in Perth;
– A young person meets with the Outreach Service Navigator every 2 to 4 weeks (with or without family/ support person), in a safe space agreed to by the young person. This should begin within 2 weeks of randomisation.
– For the first 4 weeks, the Outreach Service Navigator meets with the youth (+/- family or support person) to build rapport. Once good rapport has been established, the Outreach Service Navigator and youth (+/- family or support person) will complete a new online health assessment tool that is currently not the standard tool used by General Practitioners (GPs). This online assessment is modelled on the Check Up GP app, which was co-designed with young people and is based on the HEEADSSS (Home environment, Education and employment, Eating, peer-related Activities, Drugs, Sexuality, Suicide and depression, Safety from injury and violence) preventive health framework for interviewing adolescents. Based on the results of the new online health assessment, the Outreach Service Navigator provides feedback and negotiates a plan for their unmet needs.
– A GP at Derbarl Yerrigan Health Service, an Aboriginal-community controlled health service in Perth, will develop a mental health care plan with the youth based on the new health check. They can refer the young person to other providers, support groups, support material as necessary.
– Each 2-4 weekly session with the youth is used to understand the level of support that is needed, organise and follow through with a mental health care plan, prioritise needs, facilitate access to wellbeing activities, track progress or reassess plans. This continues for up to 5 months. Each visit is likely to last from 30 minutes to 1 hour, or longer as needed. There is no minimum or maximum number of visits within the 5 month period.
– With the support and guidance of the service navigator, the type and level of support suitable for the young person's needs is determined on an individual basis by the young person.

At the 5 month data collection timepoint, after the participant has completed their allocated 5 months of care in the intervention arm, participants will be asked if they want to be interviewed about the trial as part of a process evaluation of the trial (assessing fidelity, acceptability, potential harms).

The Outreach Service Navigator supports the health and wellbeing needs of the young person as identified by the young person, which includes their mind, body and spirit. A young person may want help with job training or taking part in Aboriginal cultural events. The Service Navigator will have up to $500 to use for activities supporting the young person’s wellbeing.

Contact between an Outreach Service Navigator and a participant will primarily be in person, unless the youth advises of another preferred form of contact (e.g. text message, phone or video call). Typically a session occurs between one participant and the Service Navigator, however some group activities may be appropriate, such as cultural activities, where there may be a small group of participants working with one Service Navigator.

The Service Navigator is a specially-trained outreach health support worker (with a background in social work, psychology and/ or health sciences) and has experience working with Australian Aboriginal communities, especially with young people and in health care or social services settings, such as case management or service coordination.

Participant adherence will be captured during the scheduled discussions at the 5 and 10 month follow-up timepoints which will record changes in the participant’s clinical health management and/ or participation in wellbeing activities at any time during the 10 month follow-up period. Also, data relating to health/ wellbeing activities will be collected from the participant at each successive visit with the service navigator which will also be used to directly assess adherence to this study arm.
Intervention code [1] 325308 0
Behaviour
Intervention code [2] 325309 0
Rehabilitation
Intervention code [3] 325310 0
Treatment: Other
Comparator / control treatment
This study arm (also known as Program 2) involves standard care at Derbarl Yerrigan Health Service, an Aboriginal-community controlled health service in Perth. This arm focusses on standard management of an individual by a General Practitioner (GP) who can refer to other providers, support groups, support material as necessary. All Aboriginal and Torres Strait Islander people are eligible for a free, annual Indigenous-specific health check delivered using item 715 on the Medicare Benefits Schedule.
It is planned that;
– A young person should attend Derbarl Yerrigan Health Service within 2 weeks of randomisation to undergo the current standard Medicare 715 health assessment. This will be followed by usual care at Derbarl Yerrigan Health Service for up to 5 months.

At the 5 month data collection timepoint, after the participant has completed their allocated 5 months of care in the control arm, participants will be asked if they want to be interviewed about the trial as part of a process evaluation of the trial (assessing fidelity, acceptability, potential harms).

End of waitlist period for Control group participants: Following the 10 month follow-up outcome measures assessment, participants from the control arm may choose to receive the intervention treatment (without any further follow-up assessments). This includes direct contact with an Outreach Service Navigator to plan and achieve health and wellbeing goals, with funds to support these wellbeing activities for a period of up to 2 months. The service navigator will have up to $200 to use for activities supporting the wellbeing of these young people. There are no further follow-up outcome assessments for this group of participants.

Participant adherence to this study arm will be captured during the scheduled discussions at the 5 and 10 month follow-up timepoints which will record changes in the participant’s clinical health management and/ or participation in wellbeing activities at any time during the 10 month follow-up period.
Control group
Active

Outcomes
Primary outcome [1] 333682 0
The difference in psychological distress according to mean score on the K10 (Kessler 10-item Psychological Distress Scale) at 5 months post-randomisation between the intervention and control arms.
Timepoint [1] 333682 0
Measured at 5 months post-randomisation.
Secondary outcome [1] 417936 0
The difference in psychological distress according to mean K10 score at 10 months post-randomisation between the intervention and control arms.
Timepoint [1] 417936 0
Measured at baseline and 10 months post-randomisation.
Secondary outcome [2] 417937 0
Change in self-rated mental health (measured using 1 multiple choice question taken from the the ‘Prevention access and risk taking in young people’ randomised controlled trial exit survey)
Timepoint [2] 417937 0
Measured at baseline, 5 and 10 months post-randomisation.
Secondary outcome [3] 417938 0
Change in self-rated physical health (measured using 1 multiple choice question taken from the ‘Prevention access and risk taking in young people’ randomised controlled trial exit survey)
Timepoint [3] 417938 0
Measured at baseline, 5 and 10 months post-randomisation.
Secondary outcome [4] 417939 0
Change in health-related quality of life (measured using the Recovering Quality of Life (ReQoL) questionnaire)
Timepoint [4] 417939 0
Measured at baseline, 5 and 10 months post-randomisation.
Secondary outcome [5] 417940 0
Change in health-related quality of life (measured using 5-level EQ-5D (EQ-5D-5L) questionnaire)
Timepoint [5] 417940 0
Measured at baseline, 5 and 10 months post-randomisation.
Secondary outcome [6] 418110 0
Change in clinical health management at any time during the 10 month follow-up period (measured via an unstructured, informal discussion about preventive health care management activities). The discussion is expected to be very short (few minutes). Typical participant responses may include: immunisation catch up, sexually transmitted infection screening, creating mental health plan. Data will be collected directly from the participant by the data collector and recorded in the trial database.
Timepoint [6] 418110 0
Measured at baseline, 5 and 10 months post-randomisation.
Secondary outcome [7] 423057 0
Fidelity will be measured as a composite of:
- Qualitative semi-structured interview, &
- Quantitative trial-specific questionnaire, &
- Analysis of study database fields or service navigator field notes describing service navigation visits,
to assess implementation of the intervention.

It includes identification of health and/ or wellbeing activities or referrals for participants, frequency of health/ wellbeing activities, proportion of activity completion, implementation barriers, unexpected outcomes and variation in service navigation delivery and service navigator training.

A member of the research team not involved in the delivery of the intervention will administer the questionnaires and undertake interviews. Interviews will be audio-recorded and may last 30 minutes or less. Interviews and questionnaire administration will occur in person, unless another form of contact is preferred.
Timepoint [7] 423057 0
- Interviews and questionnaires with participants (and their parents/ carers): 5 months post-randomisation
- Interviews and questionnaires with service navigators and Aboriginal health clinic workers & Database audit: 5 months post-randomisation for last participant recruited to trial
Secondary outcome [8] 425785 0
Change in client health attendance and service use at any time during 10 month follow-up period (measured using a culturally-appropriate questionnaire developed by economists on the trial team which documents attendance at health and other services).
Timepoint [8] 425785 0
Measured at baseline, 5 and 10 months post-randomisation.
Secondary outcome [9] 425786 0
Change in social needs (measured using a 17-item social risk screening questionnaire)
Timepoint [9] 425786 0
Measured at baseline, 5 and 10 months post-randomisation.
Secondary outcome [10] 428531 0
Acceptability of the intervention will be measured as a composite of:
- Qualitative semi-structured interview, &
- Quantitative trial-specific questionnaire (using Likert scales), &
- Analysis of study database fields or service navigator field notes describing service navigation visits,
to assess the experience and satisfaction of participants, parents/ carers, service navigators and Aboriginal health clinic workers.

Acceptability includes how engaged individuals were with the intervention, perceived utility/ usefulness/ suitability of the intervention and identification of components of the intervention that were liked, disliked or should be changed.

A member of the research team not involved in the delivery of the intervention will administer the questionnaires and undertake interviews. Interviews will be audio-recorded and may last 30 minutes or less. Interviews and questionnaire administration will occur in person, unless another form of contact is preferred.
Timepoint [10] 428531 0
- Interviews and questionnaires with participants (and their parents/ carers): 5 months post-randomisation
- Interviews and questionnaires with service navigators and Aboriginal health clinic workers & Database audit: 5 months post-randomisation for last participant recruited to trial
Secondary outcome [11] 428532 0
Potential harms of the intervention implementation will be measured as a composite of:
- Qualitative semi-structured interview, &
- Analysis of study database fields or service navigator field notes describing service navigation visits,

During the entire trial period, service navigators and Aboriginal health clinic workers will record harms.

A member of the research team not involved in the delivery of the intervention will undertake interviews. Interviews will be audio-recorded and may last 30 minutes or less. Interviews will occur in person, unless another form of contact is preferred.
Timepoint [11] 428532 0
- Interviews with participants (and their parents/ carers): 5 months post-randomisation
- Interviews with service navigators and Aboriginal health clinic workers & Database audit:
5 months post-randomisation for last participant recruited to trial

Eligibility
Key inclusion criteria
• Young Aboriginal person residing in or close to Perth, WA
• Aged 15 to 24^ years at time of consent (^must consent before 25th birthday)
• Score high to very high (score 22 or above) using the K10 measure of psychological distress
• Has legal capacity to give consent, or has a legally acceptable representative who understands the consent document and can consent on behalf of the participant
Minimum age
15 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A young Aboriginal person meeting any of the following criteria will be excluded from trial enrolment:
• Expresses suicidal ideation
• Unable to think clearly and make safe decisions (e.g. severe anorexia, immediate risk of harm)
• Unable to speak or understand English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation occurs after completion of baseline assessments to ensure allocation concealment.
A statistician not directly involved in the trial recruitment and data collection will generate a computer-generated random allocation schedule, using permuted block sizes of random sizes to maintain balance in the number of participants allocated to each study arm. The randomisation schedule will be implemented via the randomisation module in the (Research Electronic Data Capture) REDCap database. The permuted block sizes will not be released until all participants have been recruited to ensure allocation concealment.
Participants will be individually randomised 1:1 to each study arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 246 participants (123 per study arm) will have 80% power at the 5% significance level (two-sided) to detect a difference of 0.35 standard deviations in mean K10 score at five months, after allowing for a correlation between the baseline and 5 months follow-up measures of 0.5 and 20% attrition rate.

According to population statistics, 30% of Aboriginal young people will score 22 or above on the K10 (high to very high psychological distress) and will be eligible for the study. This means, of the 6000 young people in the catchment, approximately 1800 youth could be eligible to undertake this study. To recruit the required number of individuals (n=246), approximately 14% of possibly eligible individuals in the community need to consent to participate.

Data from all randomised participants will be included in an intention-to-treat analyses.

Descriptive statistics will be used to compare young people’s characteristics between study arms. Generalised linear mixed effect models with fixed effects for service, study arm, time (baseline, 5 and 10 months), time by study arm interaction, and random intercepts for individuals will be used to test for differences in mean K10 scores between study arms at 5 months (primary outcome) and 10 months (secondary outcome). Estimated intervention effect will be reported as difference in means between study arms, with 95% confidence intervals and p-values. In sensitivity analyses, pre-specified baseline variables strongly associated with the outcome will also be considered for adjustment in the regression analysis. Similar regression analyses appropriate to the data type will be performed for the secondary outcomes. A detailed statistical analysis plan (SAP) will be developed and published prior to the conducting the statistical analysis. The SAP will detail the analysis of secondary outcomes and handling of missing responses, and other supplementary analyses, such as sub-group analyses, adherence-adjusted analyses, and sensitivity analyses to assess the robustness of the missing data assumption.

We will conduct a parallel process evaluation using mixed methods (qualitative and quantitative) to assess the intervention fidelity, explore its acceptability to Aboriginal health clinic workers, service navigators, young people and their parents/carers and document any potential harms.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/12/2023
Actual
Date of last participant enrolment
Anticipated
13/12/2024
Actual
Date of last data collection
Anticipated
13/10/2025
Actual
Sample size
Target
246
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 39377 0
6004 - East Perth
Recruitment postcode(s) [2] 39399 0
6005 - West Perth
Recruitment postcode(s) [3] 39400 0
6006 - North Perth
Recruitment postcode(s) [4] 39401 0
6151 - South Perth
Recruitment postcode(s) [5] 39402 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 313085 0
Government body
Name [1] 313085 0
Department of Health and Aged Care, Medical Research Future Fund (MRFF) Million Minds Mental Health Research Mission
Country [1] 313085 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne, Victoria 3010, Australia
Country
Australia
Secondary sponsor category [1] 314773 0
None
Name [1] 314773 0
Address [1] 314773 0
Country [1] 314773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312330 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [1] 312330 0
Ethics committee country [1] 312330 0
Australia
Date submitted for ethics approval [1] 312330 0
04/11/2022
Approval date [1] 312330 0
25/11/2022
Ethics approval number [1] 312330 0
HREC1006

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

Contacts
Principal investigator
Name 124278 0
Prof Sandra Eades
Address 124278 0
School of Population and Global Health, Faculty of Medicine, Dentistry and Health Sciences, Level 2, Alan Gilbert Building, Grattan Street, The University of Melbourne, Victoria 3010 Australia
Country 124278 0
Australia
Phone 124278 0
+61 402653107
Fax 124278 0
Email 124278 0
[email protected]
Contact person for public queries
Name 124279 0
Sandra Eades
Address 124279 0
School of Population and Global Health, Faculty of Medicine, Dentistry and Health Sciences, Level 2, Alan Gilbert Building, Grattan Street, The University of Melbourne, Victoria 3010 Australia
Country 124279 0
Australia
Phone 124279 0
+61 402653107
Fax 124279 0
Email 124279 0
[email protected]
Contact person for scientific queries
Name 124280 0
Sandra Eades
Address 124280 0
School of Population and Global Health, Faculty of Medicine, Dentistry and Health Sciences, Level 2, Alan Gilbert Building, Grattan Street, The University of Melbourne, Victoria 3010 Australia
Country 124280 0
Australia
Phone 124280 0
+61 402653107
Fax 124280 0
Email 124280 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
Data collected as part of this trial can only be used for the purpose of this trial. Access to trial data is only possible for individuals approved to have access as part of trial activities or data analysis/ management. Following the completion and analysis of the trial data, trial data will be retained for the mandatory archive period.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19364Ethical approval    385305-(Uploaded-05-06-2023-06-36-40)-Study-related document.pdf



Results publications and other study-related documents

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