KeySteps@JC - Early Child Intervention
Condition: Lower Socioeconomic Background
Study type: Interventional

Summary: 
      The proposed early intervention is grounded within a framework that incorporates two key
      aspects: a multi-level component with nested or layered contexts, and a growth aspect with
      early and on-going social investments to mitigate disparate trajectories among
      underprivileged children. Capital is built across multiple levels over a three-year period
      during the critical window of early childhood - among the young children themselves plus
      their primary caregivers and teachers (Level 1), the family unit and school environment
      (Level 2), and the larger community (Level 3) that includes infrastructure for extended
      learning and bridges with other resource institutions. Schools will be stratified and then
      randomized to receive an integrated multi-disciplinary intervention or a health consultation
      control. Evaluation will include a comprehensive battery to assess baseline capacity in
      children, parents, teachers, relationship characteristics between them, as well as the early
      learning environment at home and at school (Year 1), repeated measures to index intermediate
      (ongoing for specific individual and family domains, 3 months for school changes, annual
      progress reports) and final response (Year 3) to treatment, and age- and time-appropriate
      (e.g. age 4, 5, 6; stage of parenting; experience of teachers) indices of functioning at each
      annual checkpoint.
    

Detailed description: 
      Socioeconomic disadvantage permeates multiple levels of environmental contexts in which
      children are raised, including the family environment and schools. Disparities in life
      outcomes can be observed in early childhood and developmental gaps widen over time. Continued
      exposure to adverse conditions propagates the developing child on an increasingly risky
      trajectory. This study aims to mitigate the adverse effect of socioeconomic disadvantage on
      children and their families.

      This is a clustered randomised controlled study recruiting 32 kindergartens in two
      underprivileged districts (16 in each district) in Hong Kong. District is a blocking factor.
      Within each district, 8 kindergartens will be randomised in comprehensive intervention group
      while the remaining 8 will be in health support group. The families in the comprehensive
      intervention will receive a holistic package of interventions, including child interactive
      intervention, family empowerment, and health support. The families in the health support
      group will only receive health support intervention.

      In addition, a stepped wedge cluster randomised control trial design will be used to deliver
      and evaluate the health intervention package (health seminars/workshops, dental
      check-up/treatment, visual check-up/treatment). The schematic diagram of the design is shown
      in the figure below.

      Another randomisation will be conducted to determine the sequence in which the health
      intervention takes place. 4 KGs will be provided with the health intervention in each month
      sequentially from Nov 2018 to Jun 2019 (totally 8 months). The randomisation should ideally
      be stratified by district (SSP/TSW) and the original group allocation (Comprehensive/Health).
      In other words, in each month, 1 KG from SSP Comprehensive, 1 from SSP Health, 1 from TSW
      Comprehensive, 1 from TSW Health will receive the health intervention package.

      In analysis, the time exposed to intervention (e.g. Gp1 exposed to 8 months at Jun 2018) will
      be used to evaluate the effect of the intervention. Since the time exposed to intervention
      (i.e. the starting time of the intervention) is randomised, internal validity should be
      ensured. In addition, the stratification of district and the original group allocation should
      eliminate the influence of these factors.
    

Intervention name(s): Child interactive intervention; Family Empowerment; Access to Community Hub and its services; Enhancement to the kindergartens; Health education, screening, and support
Intervention type(s): Behavioral; Behavioral; Behavioral; Other; Other
Intervention description(s): The Child Interactive Intervention will be delivered through a Dialogic Reading Program, which is an individual/group level intervention component for both families and kindergartens. The original Dialogic Reading Program aims to enhance children's literacy and oral language skills by using the specific technique of shared book reading developed by Whitehurst and colleagues (1988). However, this project will expand from the original Dialogic Reading Program template to include alignment with local kindergarten curriculum and themed interactive activities that help build social competence and emotional maturity in children, in addition to cognitive skills.; Family empowerment in this project can be conceptualized across three main pillars: 1) adaptive parenting; 2) adaptive extended family environment; and 3) familial resources. Typically, adaptive parenting is translated into positive parenting programs for primary caregivers, and the rest of the family environment involves extended caregivers. However, families from disadvantaged environments encounter many hurdles that hinder effective parenting and relationship nurturing, and parents' mental wellbeing are also consistently impacted by competing demands.; A new model of Community Hub will be implemented and there will be two hubs established in two respective districts. The Community Hubs act as an alternative venue to implement service delivery of intervention packages, such as activity sessions in the Child Interactive Intervention, Parenting Program, and mentor-mentee experience exchange, which provide families institutional flexibility and extended support while internalizing new practices. There will also be health education, consultation support and developmental assessments. The Hubs will play the roles of promoting and interweaving play-based learning into the lives of families frequently faced with competing demands and a lack of resources, and enable a protracted network for parents.; This intervention package aims at providing a better physical and social kindergarten environment to maximize developmental reach and expedite timely interception and feedback without adding burden to teachers and frontline service professionals.; Health seminars and interactive workshop will be provided to the families. Screen for common child health problems (e.g. dental and visual) will also be conducted. A support hotline and website will be established for the participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care