Clinical trial NCT03615937: KeySteps@JC - Early Child Intervention
Official title: KeySteps@JC - Early Child Intervention for Underprivileged Families in Hong Kong
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Socioeconomic Background
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 1216
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. K1 children \[\~3 years\], with a selected Pre-Nursery group \[\~2 years\], and their families attending participating kindergartens.
2. Kindergartens located at Sham Shui Po and Tin Shui Wai districts in Hong Kong based on the following criteria:

   1. Full-day program
   2. Pre-Primary Education Voucher Scheme
   3. Basic school facilities (minimally \>1 classroom and a basic activity room available)
   4. Average school tuition fee in the past 5 years (\<HKD 40,000)
   5. Proportion of teachers with early childhood education bachelor degrees or above. Teachers of participating children will be their facilitators/assessors in this study.

Exclusion Criteria:

1. Children and families from non-participating kindergartens; children below and above K1 (except for a selected Pre-Nursery group).
2. Non-English/Chinese speaking subjects.
3. Teachers of non-participating children and kindergartens.
4. Non-consenting subjects.

Primary outcomes:
measure: Child development
timeFrame: Three years after start of intervention
Secondary outcomes:
measure: Physical health and well-being
timeFrame: Three years after start of intervention
measure: Socio-emotional development
timeFrame: Three years after start of intervention
measure: Neurocognitive development
timeFrame: Three years after start of intervention
measure: Parental Capacity and Parenting Practices
timeFrame: Three years after start of intervention
measure: Parenting and developmental literacy
timeFrame: Three years after start of intervention
measure: Parental mental health and emotion processing
timeFrame: Three years after start of intervention
measure: School readiness
timeFrame: Three years after start of intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Patrick Ip
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leung C, Hui ANN, Wong RS, Rao N, Karnilowicz W, Chung K, Chan J, Ip P. Effectiveness of a Multicomponent Parenting Intervention for Promoting Social-Emotional School Readiness Among Children From Low-Income Families in Hong Kong: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2022 Apr 1;176(4):357-364. doi: 10.1001/jamapediatrics.2021.6308.