Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001207606
Ethics application status
Approved
Date submitted
20/12/2022
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
Maawit Maladjin: Targeting child development in Urban Aboriginal children.
Scientific title
Assessing the effect of the Care for Child Development package on early child neurodevelopment in Urban Aboriginal children.
Secondary ID [1] 308319 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
early child neurodevelopment 328099 0
maternal mental health 328100 0
parent responsiveness 328101 0
Condition category
Condition code
Public Health 325560 325560 0 0
Health service research
Mental Health 325621 325621 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Primary health care workers (Interventionists) in the treatment group will be trained to deliver the WHO/UNICEF Care for Child Development (CCD) package at each child health check in the first year of life. The CCD package promotes caregivers’ sensitivity and responsiveness using developmentally appropriate play and communication activities. The package contains a set of age-specific messages about care for child development and problem-solving. Caregivers try an age-specific play using objects readily available in the home and communication activities with their child while the primary health care worker observes, coaches, and provides feedback to enhance the quality of the interactions. Examples for infants 1 week up to 6 months include providing ways for child to see, hear, feel and move freely. Slowly move colourful things for the child to see and reach. Smiling and laughing with the child. Talking to the child. Get a conversation going by copying child’s sounds or gestures. Parents and caregivers will be encouraged to engage in activities with their child at every available opportunity.
In our trial, twelve Interventionists will be employed to deliver the CCD package at universal child health checks within the first 12 months: birth-14 days, eight weeks, four months, 12 months. Depending on availability of families, each visit takes approximately 7-30 minutes and can be delivered individually or as a group. The Interventionists in the first instance will be Aboriginal Health Workers and, when not available, nurses or child health nurses who have experience working with Aboriginal families. All interventionists will receive extensive training and ongoing mentoring on how to deliver the CCD package. The training will be delivered by trained trainers (Facilitators). These facilitators (child health nurse and or midwife) will be provided face to face training by the Supervisor trainer (social psychologist and program developer). This training will be for 1 week (40hrs) and include an extra observed practice with 20 caregiver counselling interactions (up to an extra week). The trial interventionists will be trained by the Facilitators. This training will be for 3 – 4 days. Interventionists will also be observed for 10 hours following initial training. The supervisor trainer will then provide online support and observation for each interventionist and facilitator for one hour each month.

A process evaluation will be developed to monitor and evaluate the intervention implementation. This will use the existing monitoring and evaluating tools developed by UNICEF and WHO developed specifically for the intervention.
Intervention code [1] 324768 0
Prevention
Intervention code [2] 325157 0
Behaviour
Comparator / control treatment
The control group will receive Universal Services, Universal Plus, and Partnership Child Health Services depending on the child's need from their respective health services and determined by the assessing clinician in accordance with evidence based universal contact guidelines. Western Australian child health checks completed in the first year are from birth-14 days, eight weeks, four months, and 12 months. During these checks (30 mins), families are expected to receive information on physical, social and emotional development and sensitive responses to their child’s cues. Children in the control group will not receive any additional CCD support.
Control group
Active

Outcomes
Primary outcome [1] 332980 0
Infant cognitive development as measured by the Bayley-4 Aus/NZ version
Timepoint [1] 332980 0
Infant 12 months old
Secondary outcome [1] 415411 0
Infant cognitive neurodevelopment as measured by the Bayley-4 Aus/NZ version
Timepoint [1] 415411 0
Infants 24 months old
Secondary outcome [2] 416918 0
Infant language development as measured by the Bayley-4 Aus/NZ version
Timepoint [2] 416918 0
Infant 12 and 24 months old
Secondary outcome [3] 416919 0
Infant motor development as measured by the Bayley-4 Aus/NZ version
Timepoint [3] 416919 0
Infant 12 and 24 months old
Secondary outcome [4] 416920 0
Maternal mental health using the culturally adapted nine-item Patient Health Questionnaire (aPHQ-9) for Aboriginal people
Timepoint [4] 416920 0
Infant 12 and 24 months old
Secondary outcome [5] 416921 0
Parent responsiveness as measured by the Observation of Mother-Child Interactions tool
Timepoint [5] 416921 0
Infant 12 and 24 months old
Secondary outcome [6] 416922 0
Process evaluation surveys with mothers. A brief survey asking families of their home environment and their experience.
Timepoint [6] 416922 0
When the infant is 4, 12 and 24 months old
Secondary outcome [7] 416924 0
Australian Early Development Census. This will be individual child data. We will assess the domain of whether a child is developmentally vulnerable on one or more domain(s) (DV1)
Timepoint [7] 416924 0
Child at 4-5 years old
Secondary outcome [8] 416925 0
Has a child health attended their health checks through administrative data from the Western Australian Child and Adolescent Health Service
Timepoint [8] 416925 0
Total child health checks completed up to 5 years old.
Secondary outcome [9] 416926 0
Ages and Stages Questionnaire communication domain
Timepoint [9] 416926 0
Child at 4 years old
Secondary outcome [10] 417194 0
Acceptability of delivering the intervention. Data collected by interviews with health service providers. One to one interviews that will be audio-recorded.
Timepoint [10] 417194 0
At 18 months post-intervention commencement
Secondary outcome [11] 427052 0
Process evaluation interviews with mothers to determine feasibility of the intervention. One-on-one interviews with mothers when their infants is 6 months old.
Timepoint [11] 427052 0
Infant is 6 months old
Secondary outcome [12] 427468 0
Australian Early Development Census. This will be individual child data. We will assess
the domain of whether a child is developmentally vulnerable on two or more domains (DV2)
Timepoint [12] 427468 0
Child at 4-5 years old
Secondary outcome [13] 427469 0
Australian Early Development Census. This will be individual child data. We will assess
the child's Multiple Strengths Indicator (highly developed, well developed and emerging strengths)
Timepoint [13] 427469 0
Child at 4-5 years old
Secondary outcome [14] 427470 0
Cost-effectiveness evaluation. We will estimate the total cost for CCD intervention and usual care and calculate the average cost per child and mother for interventions and usual care separately. Cost data will be extracted from all relevant costs that will incur for providing CCD intervention and usual care. For example, cost of the interventions (i.e. CCD kits) and the costs of primary health care workers' functioning, including primary health care worker training and supervision. Indirect costs, such costs for food and transport, will not be included in our cost estimate.
Timepoint [14] 427470 0
Post-intervention completion
Secondary outcome [15] 427473 0
Process evaluation data - A project log including number of times families were contacted for the intervention, time spent and materials delivered during the intervention will be collected.
Timepoint [15] 427473 0
Recorded at intervention time points when the infant is 0-4 weeks old
Secondary outcome [16] 428705 0
Process evaluation data - A project log including number of times families were contacted for the intervention, time spent and materials delivered during the intervention will be collected.
Timepoint [16] 428705 0
Recorded at intervention time points when the infant is 8 weeks old
Secondary outcome [17] 428708 0
Process evaluation data - A project log including number of times families were contacted for the intervention, time spent and materials delivered during the intervention will be collected.
Timepoint [17] 428708 0
Recorded at intervention time points when the infant is 4 months old
Secondary outcome [18] 428709 0
Process evaluation data - A project log including number of times families were contacted for the intervention, time spent and materials delivered during the intervention will be collected.
Timepoint [18] 428709 0
Recorded at intervention time points when the infant is 12 months old
Secondary outcome [19] 428712 0
Ages and Stages Questionnaire gross motor domain
Timepoint [19] 428712 0
Child at 4 years old
Secondary outcome [20] 428713 0
Ages and Stages Questionnaire fine motor domain
Timepoint [20] 428713 0
Child at 4 years old
Secondary outcome [21] 428714 0
Ages and Stages Questionnaire problem solving domain
Timepoint [21] 428714 0
Child at 4 years old
Secondary outcome [22] 428715 0
Ages and Stages Questionnaire personal-social domain
Timepoint [22] 428715 0
Child at 4 years old
Secondary outcome [23] 428716 0
Whether a child has attended Child development services assessed through administrative data from the Western Australian Child and Adolescent Health Service
Timepoint [23] 428716 0
Infant - birth to 24 months old
Secondary outcome [24] 428717 0
Whether a child has attended Child development services assessed through administrative data from the Western Australian Child and Adolescent Health Service
Timepoint [24] 428717 0
up to 5 years old
Secondary outcome [25] 428718 0
Has a child health attended their health checks through administrative data from the Western Australian Child and Adolescent Health Service.
Timepoint [25] 428718 0
Infant - birth to 24 months old.
Secondary outcome [26] 429170 0
Feasibility of delivering the intervention. Data collected by interviews with health service providers. One to one interviews that will be audio-recorded.
Timepoint [26] 429170 0
At 18 months post-intervention commencement
Secondary outcome [27] 429173 0
Process evaluation interviews with mothers to determine feasibility of the intervention. One-on-one interviews with mothers when their infants is 6 months old.
Timepoint [27] 429173 0
Infant is 6 months old

Eligibility
Key inclusion criteria
Infants

Either:

Primary inclusion criterion: Is Aboriginal or Torres Strait Islander

or

Only in the event that issues with recruitment are identified, agreed and communicated by the Senior Management Team: all other children attending Child and Adolescent Health Service will be invited to participate.

Resides in the Perth metropolitan area and is able to attend child health checks at a Perth metropolitan Child and Adolescent Community Health site.

Parent/guardian or legally acceptable representative is willing and able to provide written informed consent for the child to participate

Health Service Providers

Interventionists and those health service providers involved in supporting the intervention will be invited to participate in the outcomes of the study.
Minimum age
0 Months
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Parent/guardian inability or unwillingness for them or their child to complete the trial related procedures and follow-up

2. Any other reason as determined by the investigator that makes the child unsuitable for enrolment in the trial

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The random allocation schedule will be generated by a statistician independent of the trial, who will upload the schedule into REDCap. The schedule will not be accessible by the Recruitment/Retention Officer until assignment, at which time the allocation will become available upon entering the participant's details. The randomisation will be restricted using one large permuted block for the entire trial to ensure the allocation ratio is maintained at the end of the trial. For infants assigned to the CCD group, they will also be randomly assigned to a health care worker who will deliver the CCD package throughout the trial. In addition to randomising infants to interventions, randomising infants to health care workers has the benefit of reducing confounding bias due to variation in health care worker and infant characteristics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be restricted using one large permuted block for the entire trial to ensure the allocation ratio is maintained at the end of the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimation
The sample size calculation is based on the findings from two trials included in our review (with an effective same size of 244 participants) that examined the effect of combined responsive caregiving and early learning on cognitive development. The meta-analysed effect indicated an improvement of 6.1 (95% CI -4.3 to 16.5) units at 12 months on the Bayley scale (range 0 to 160) for those receiving the intervention compared with usual care. A difference of this size has been shown to have an important impact, equivalent to improvements arising from breastfeeding for more than eight months. A sample of 204 and 200 infants in the intervention and control groups, respectively, will be sufficient to detect a difference of 6.1 with 90% power. This assumes a two- sided alpha = 0.05, a standard deviation of 15.2 (assumed from the largest trial, so yielding the most stable estimate), and includes adjustment for potential clustering arising in the intervention group from each health care worker (HCW) delivering the intervention to multiple participants (assuming an intra- HCW-correlation [I-HCW-C] of 0.05, 12 HCWs, and 17 infants per HCW). This calculation is sensitive to the assumption regarding the size of the I-HCW-C; however, estimates of I-HCW-C < 0.11 will still yield at least 80% power. Adjusting for an anticipated 20% attrition, we plan to recruit 264 (22 infants per HCW) infants in the intervention and 250 infants in the control group.

Statistical methods and/or analysis plan
Effectiveness analysis - Linear mixed models will be used to estimate the intervention effects. These models will include a random effect for the health care worker, a term for time and an interaction term between time and intervention group, allowing the magnitude of the effect to vary by time. Data will be analysed according to the group that participants were randomised. Linear mixed models yield unbiased estimates of intervention effect when data are missing completely or missing at random. Sensitivity analyses will also be undertaken to investigate the robustness of the intervention estimates to different assumptions about the missing data.

Cost-effectiveness analysis - A Cost-Effectiveness Analysis (CEA) will be undertaken of the CCD intervention compared to usual care for outcomes: infant cognitive development, language and motor development and maternal mental health at 12 and 24 months. The CEA will examine whether CCD interventions improve the early child neurodevelopment of the Aboriginal children and maternal mental health of the Aboriginal mothers and thus bring better value for money for WA health systems. Five separate CEA models will be developed based on the outcomes from the perspective of the WA health system. The reference year for CEA will be 2026. Costs and outcomes data will be collected from the CCD interventions and usual care comparator group. Annuitization will be done for the capital items and machineries with a lifespan of more than one year, applying a 5% discount rate.

The total cost for CCD intervention and usual care will be estimated and calculate the average cost per child and mother for interventions and usual care separately. Five incremental cost-effectiveness ratios, the incremental cost per additional outcome for CCD interventions compared to the usual care will then be calculated. Five cost-effectiveness planes will be drawn applying 5000 bootstrap simulations and scatterplot in order to demonstrate dominant intervention and thus will identify the most cost-effective/cost-saving intervention. 95% confidence intervals will be estimated using bootstrapped 5000 replications to examine the distribution of each of our five ICER (incremental cost-effectiveness ratio) estimates. Sensitivity analysis will also be undertaken using plausible assumptions to examine the robustness of the original ICER estimates.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/01/2024
Actual
Date of last participant enrolment
Anticipated
27/12/2024
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
514
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 312563 0
Government body
Name [1] 312563 0
National Health and Medical Research Council (NHMRC)
Country [1] 312563 0
Australia
Funding source category [2] 314871 0
Charities/Societies/Foundations
Name [2] 314871 0
Stan Perron Charitable Trust/Programs and Partnerships Grant
Country [2] 314871 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
2 Bradford St, Mount Lawley 6050 Western Australia
Country
Australia
Secondary sponsor category [1] 316868 0
None
Name [1] 316868 0
Address [1] 316868 0
Country [1] 316868 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311892 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [1] 311892 0
Ethics committee country [1] 311892 0
Australia
Date submitted for ethics approval [1] 311892 0
16/01/2023
Approval date [1] 311892 0
16/02/2023
Ethics approval number [1] 311892 0
Ethics committee name [2] 312151 0
Child and Adolescent Health Service
Ethics committee address [2] 312151 0
Ethics committee country [2] 312151 0
Australia
Date submitted for ethics approval [2] 312151 0
16/02/2023
Approval date [2] 312151 0
20/03/2023
Ethics approval number [2] 312151 0
Ethics committee name [3] 312152 0
Edith Cowan University
Ethics committee address [3] 312152 0
Ethics committee country [3] 312152 0
Australia
Date submitted for ethics approval [3] 312152 0
11/05/2023
Approval date [3] 312152 0
09/06/2023
Ethics approval number [3] 312152 0

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

Contacts
Principal investigator
Name 122742 0
Prof Daniel McAullay
Address 122742 0
Edith Cowan University, Kurongkurl Katitjin, 2 Bradford St, Mount Lawley 6050, Western Australia
Country 122742 0
Australia
Phone 122742 0
+61 863045479
Fax 122742 0
Email 122742 0
d.mcaullay@ecu.edu.au
Contact person for public queries
Name 122743 0
Natalie Strobel
Address 122743 0
Edith Cowan University, Kurongkurl Katitjin, 2 Bradford St, Mount Lawley 6050, Western Australia
Country 122743 0
Australia
Phone 122743 0
+61 863045481
Fax 122743 0
Email 122743 0
n.strobel@ecu.edu.au
Contact person for scientific queries
Name 122744 0
Natalie Strobel
Address 122744 0
Edith Cowan University, Kurongkurl Katitjin, 2 Bradford St, Mount Lawley 6050, Western Australia
Country 122744 0
Australia
Phone 122744 0
+61 863045481
Fax 122744 0
Email 122744 0
n.strobel@ecu.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
As this trial involves Aboriginal and Torres Strait Islander recruitment, data sharing will be governed by our cultural advisory group and will be determined by data sovereignty principles.
The decision to share data will be decided by this group at a later date.


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.