KeySteps@JC - Early Child Intervention

Not Applicable

Completed

• Conditions: Lower Socioeconomic Background
• Interventions: Behavioral: Child interactive intervention; Other: Health education, screening, and support; Behavioral: Family Empowerment; Behavioral: Access to Community Hub and its services; Other: Enhancement to the kindergartens

• Registration Number: NCT03615937
• Lead Sponsor: The University of Hong Kong

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-06
• Study Start: 2018-10-01
• Primary Completion: 2021-09-30
• Study Completion: 2022-07-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1216

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comprehensive Intervention	Child interactive intervention	This is a holistic package of interventions, including: 1. Child interactive intervention (dialogic reading and play intervention) 2. Family Empowerment (positive parenting and grandparenting) 3. Access to Community Hub and its services 4. Enhancement to the kindergartens 5. Health education, screening, and support
Comprehensive Intervention	Family Empowerment	This is a holistic package of interventions, including: 1. Child interactive intervention (dialogic reading and play intervention) 2. Family Empowerment (positive parenting and grandparenting) 3. Access to Community Hub and its services 4. Enhancement to the kindergartens 5. Health education, screening, and support
Health Support	Health education, screening, and support	This is a control arm with only health components. 1. Health education, screening, and support
Comprehensive Intervention	Enhancement to the kindergartens	This is a holistic package of interventions, including: 1. Child interactive intervention (dialogic reading and play intervention) 2. Family Empowerment (positive parenting and grandparenting) 3. Access to Community Hub and its services 4. Enhancement to the kindergartens 5. Health education, screening, and support
Comprehensive Intervention	Health education, screening, and support	This is a holistic package of interventions, including: 1. Child interactive intervention (dialogic reading and play intervention) 2. Family Empowerment (positive parenting and grandparenting) 3. Access to Community Hub and its services 4. Enhancement to the kindergartens 5. Health education, screening, and support
Comprehensive Intervention	Access to Community Hub and its services	This is a holistic package of interventions, including: 1. Child interactive intervention (dialogic reading and play intervention) 2. Family Empowerment (positive parenting and grandparenting) 3. Access to Community Hub and its services 4. Enhancement to the kindergartens 5. Health education, screening, and support

Primary Outcome Measures

Name	Time	Method
Child development	Three years after start of intervention	Full scale score of Hong Kong Early Child Development Scale (HKECDS); The HKECDS includes items from the following eight subscales: Personal, Social and Self-Care (7 items), Language Development (13 items), Pre-academic Learning (27 items), Cognitive Development (10 items), Gross Motor (12 items), Fine Motor (9 items), Physical Fitness, Health and Safety (7 items), and Self and Society (10 items). The items are scored on a 0/1 basis. The subscale items can be summed to a total score. Higher score indicate better developmental outcomes.

Secondary Outcome Measures

Name	Time	Method
Parenting and developmental literacy	Three years after start of intervention	Aggregated score based on validated tools such as Parent-Child Interaction Scale, Parenting Styles and Dimensions Questionnaire using principal component analysis
Parental mental health and emotion processing	Three years after start of intervention	Aggregated score based on validated tools, such as General Self-Efficacy Scale, Connor Davidson Resilience Scale using principal component analysis
School readiness	Three years after start of intervention	Total scale score of the Chinese Early Development Instrument using principal component analysis
Physical health and well-being	Three years after start of intervention	Aggregated score based on physical and health assessments such as body height and weight, blood pressure, spirometry, ultrasound measured bone density, and skin prick test using principal component analysis
Socio-emotional development	Three years after start of intervention	Aggregated score based on validated tools such as Strength and Difficulties Questionnaires and Chinese Early Development Instrument using principal component analysis
Neurocognitive development	Three years after start of intervention	Aggregated score based on validated tools such as Hong Kong Early Child Development Scale and Parents' Evaluation of Developmental Status using principal component analysis
Parental Capacity and Parenting Practices	Three years after start of intervention	Aggregated score based on validated tools such as Parent-child Conflict Tactics Scale using principal component analysis

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong