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Maawit Maladjiny: Targeting child development in Urban Aboriginal children.

Assessing the effect of the Care for Child Development package on early child neurodevelopment in Urban Aboriginal children.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001207606
Enrollment
400
Registered
2023-11-23
Start date
2026-04-01
Completion date
2027-03-31
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Despite the high burden of developmental vulnerability in Aboriginal infants, there has been no systematic implementation of early child neurodevelopment programs starting in the first four weeks of life (neonatal period) implemented by primary health care providers. We will be addressing developmental vulnerabilities by implementing the “Care for Child Development” program in Aboriginal and Torres Strait Islander (Aboriginal) children in Perth, Western Australia. Australia has a well-funded and developed universal health care system. Yet, almost 1 in 3 Aboriginal children commence school in Western Australia with at least two developmental vulnerabilities. The ‘Care for Child Development’ (CCD) program, created by WHO and UNICEF, provides an evidence-based, theoretically sound model for improving early child development, parental responsiveness and maternal depression in low and middle-income countries. The CCD program has been implemented in 19 countries and 23 sites, with providers in a range of sectors being able to implement the approach after appropriate training. It combines responsive caregiving and promoting early learning, can be delivered from the first month of life up to 36 months and provides caregivers with practical recommendations on playing, responsive stimulation, caregiver-child interaction, and maternal depression. The most recent effectiveness study of the CCD program in a large, factorial, cluster-randomized trial published in The Lancet Global Health found ‘low intensity’ CCD delivered to infants aged 0-24 months resulted in substantial improvements at 12 and 24 months in cognitive child development compared to the control group. We will undertake a 2-year community-based, randomised effectiveness trial of 400 caregiver-infant pairs with a team of national and international experts. We aim to address the low level of an Aboriginal child’s development attainment by improving primary health care’s capability to deliver world-leading child development services for Aboriginal babies and children. We will do this by determining whether the CCD program delivered through child health checks from the neonatal period will improve caregivers’ abilities to play, communicate and respond to their child’s neurodevelopmental needs throughout the first 24 months of life postpartum.

Interventions

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

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.

Primary health care workers (CCD Workers) 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 readi

Primary health care workers (CCD Workers) 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, individuals with a background in nursing, early childhood development, childhood education or similar will be employed as CCD Workers to deliver the CCD package at the same timepoints as the universal child health checks within the first 12 months: birth-4 weeks, 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. All CCD Workers 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). CCD Workers will undergo theory and practical training for 2 days. They will also be observed for 10 hours following initial training. The supervisor trainer will then provide online support and observation for each CCD worker and facilitator for one hour each month. In addition to face-to-face contacts, educational animated videos up to 30 seconds on age-appropriate play and communication activities will be developed and provided on an invite only Instagram account that intervention families will be invited to. These videos will be released when the first infants turn 6, 9 and 18 months old. 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.

Sponsors

Edith Cowan University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
0 to 80 Years
Healthy volunteers
Yes

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 4, 2026