ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621001140842

Ethics application status

Approved

Date submitted

28/05/2021

Date registered

23/08/2021

Date last updated

23/08/2021

Date data sharing statement initially provided

23/08/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

A Good Start in Life for Young Children: Investigating the impact of place-based interventions for young children at risk of developmental vulnerability

Scientific title

A Good Start in Life for Young Children: Investigating the impact of place-based interventions on the health and wellbeing of young children at risk of developmental vulnerability

Secondary ID [1]

Pure Award ID – 42611725

Universal Trial Number (UTN)

U1111-1268-7973

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Inadequate nutrition

Impaired speech development

Impaired physical development

Impaired social and emotional regulation

Condition category

Condition code

Public Health

Health service research

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Arm 1: Education and Training – In the ACT there is an unmet need for the delivery of occupational therapy and speech pathology services for disadvantaged, low income, and refugee families. The study is a pre-test-post-test non-equivalent groups design. This arm of interventions will be provided in consultation with the services within the intervention suburbs. An individual needs analysis will be conducted to assess the appropriateness of each intervention to ensure targeted service delivery. Additionally, the availability of intervention programs will be considered across the length of the trial. The University of Canberra runs a student led allied health service from its University Health Hub. Allied health services will be delivered as ‘outreach services’ to access vulnerable children and families in the community. Service delivery will focus on early speech and language development, attention, concentration, and readiness to learn, gross and fine motor skills, social skills, and nutrition. Services will be delivered at local playgroups, community centres, preschools and early childhood, education and care services by students completing their Work Integrated Learning (WIL) in their undergraduate or post-graduate allied health degrees supervised by Clinical Educators funded by the Good Start in Life project. Students are training in their specialities through their degrees and will be trained in the below programs as needed, however our Clinical Educators are trained in the programs. Individuals and small groups of children and families as well as early childhood educators and support workers will be involved in this arm of the intervention that will be delivered face-to-face. The education and training programs offered (examples of specific programs include, the Hanen Centre's Learning Language and Loving It™, Read It Again and Parents as Teachers) will help with language development, literacy skills, promoting social interaction, play and participating in home, community and early learning environments. The programs will be offered at least once per week in the included services for approximately 2 hours per session, The programs will be delivered to children aged 2 – 5 years old and will run for the duration of the project, which is anticipated to be 3 years with the possibility of extension, pending additional funding. Sign in sheets will be used for each program as a strategy to monitor adherence to the interventions.

Arm 2: Good Start in Active Play – The Good Start in Life Active Play program (based on the Kids at Play Active Play ACT Department of Health program) will help train early childhood educators and health professionals feel confident to promote active play and teach fundamental movement skills to children aged three to five. Training by WIL University of Canberra allied health students includes practical ‘hands on’ skills sessions to assist educators to apply the learnings in their setting. Types of play encouraged will include structured and unstructured play, indoor and outdoor play, playing alone or in a group. Active play encourages fine and gross motor skill development, socialisation, confidence, self-esteem, thinking skills and emotional regulation. This program enables services to encourage children to engage in the recommended 25 minutes of active play per day and facilitate free play opportunities. The training will occur within the early childhood, education and care services, preschool, and playgroups. Each training session will run for approximately 2-hour blocks across 4 sessions and will run for the duration of the project, which is anticipated to be 3 years with the possibility of extension, pending additional funding. Sign in sheets will be used for each program as a strategy to monitor adherence to the interventions.

Arm 3: Loose Parts Play ‘Pop Ups’ – Loose Parts Play is a type of play that supports invention, divergent thinking, problem solving, helps to develop and refine gross motor-skills and encourages children to challenge themselves and explore their physical abilities in a safe environment. These activities will be provided in public spaces and places, in local neighbourhood areas, playgroups and pre-schools. The activities involving unstructured play with loose parts will be facilitated by allied health degree students completing their WIL. The Good Start in Life project will supply the instruments used in the Loose Parts Play ‘pop ups’ that will be tailored to the specific environment. The ‘pop ups’ will be offered at least once per week in the intervention suburbs for approximately 2 hour per session and will run for the duration of the project, which is anticipated to be 3 years the possibility of extension, pending additional funding. The ‘pop ups’ will be delivered in parks and recreation areas for children and family members to participate in, as such there will be no age limit. Examples of themes for each session will vary, examples include, animals (create a farm), music (make musical instruments) etc. Sign in sheets will be used for each program as a strategy to monitor adherence to the interventions.

Arm 4: Family Liaison Coordinator – Most children and their caregivers encounter a myriad of systems throughout the course of their child’s development. For families who face complex challenges and multiple disadvantages in their everyday lives, navigating the different health, education and community sectors and multiple service networks can be extremely challenging. The Family Liaison Coordinator employed by the Good Start in Life project for the duration of the project - which is anticipated to be 3 years with the possibility of extension, pending additional funding - has a background in the early childhood sector and will work with families and services across our intervention sites to bridge systems and services by assisting families in obtaining referrals or appointments to health specialists where needed. The Family Liaison Coordinator will be contactable through email and phone to facilitate continuity of care for children, parents and caregivers and support and educate the professionals that they work alongside. Additionally, the Family Liaison Coordinator will be available within services in the intervention suburbs at pre-arranged, advertised times to facilitate better connections between professionals, services, and sectors improving service integration.

Arm 5: Service Integration Measure – To gauge the current level of integration between health, education, and social services for children and to monitor changes to the network over time, representatives from early childhood education and care centres, playgroups and preschools will be asked to participate in this research. The research team will identify which services are currently working together. This will be achieved through the completion of an adapted Human Services Integration Tool (Browne et. al., 2007) by representatives from education centres in the identified intervention suburbs. If any collaborations are identified, the research team will then contact the collaborating services and request completion of the Collaboration Rubric Tool to determine the scope and depth of the integration. The tools will take 10 – 20 minutes to complete online. Finally, the participants will be invited to complete an interview conducted by the research team to further understand the current level of integration the centre has with other services, what collaboration means to them, and the barriers and facilitators to collaboration. The interviews will range from 30 – 60 minutes, one-on-one, face-to-face or videoconferencing and will be recorded and analysed for qualitative data by the research team with consent.

Intervention code [1]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

The control group is the Tuggeranong District Area and no treatment or intervention will occur within this district, this area will receive ‘usual care’. The term ‘usual care’ is defined for the purpose of this study as the provision of early childhood education and care services without the study implementing interventions in the control group.

Control group

Active

Outcomes

Primary outcome [1]

Any change assessed independently in the number of children identified as developmentally vulnerable in the domain of physical health and wellbeing in the Belconnen District Area identified by the 2024 Australian Early Development Census data.

Timepoint [1]