- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04512352
An Early Childhood Internet-based and Family-based Intervention Study (ECII)
A Large Scale Cross-sectional Survey and a Randomized Control Study on the Effectiveness of an Early Childhood Family-Based and Internet-Based Intervention
The poverty rate among children under 18 years old in Hong Kong in 2015 was 18% after social welfare intervention. James Heckman, a Nobel Prize winner in Economics, advocates early childhood investment to enhance social mobility, given its lifelong impact of on child development. However, few randomized control trails have been used to examine the effectiveness of early childhood intervention in promoting social mobility through child development in Hong Kong. To fill these gaps, we propose an interdisciplinary intervention study involving academics from economics, sociology, social work, gerontology, education, and psychology to investigate methods to promote the social mobility of children living in poverty through early intervention.
The overall objective is to enhance the developmental outcomes of children in poverty by utilizing parental resources within a family system, technological resources available in modern metropolis and the human resources enjoyed by the elderly in Hong Kong.
The primary objective is to evaluate an internet- and family-based intervention to promote the development of children in poverty aged 24 months to three years. The examined outcome will be the developmental well-being of participating children, with the long-term goal of promoting their social mobility to break the cycle of poverty. In the long run, we aim to establish the proposed intervention in policy to promote the development of disadvantaged children.
The secondary objective is to identify intergenerational volunteerism as a means for productive aging through a mentoring program using older adults as mentors to participating parents.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Hong Kong Christian Service
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Hong Kong, Hong Kong
- Hong Kong Lutheran Social Service
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Hong Kong, Hong Kong
- Hong Kong Young Women's Christian Association
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Hong Kong, Hong Kong
- Po Leung Kuk
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Hong Kong, Hong Kong
- The Salvation Army
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Hong Kong, Hong Kong
- Tung Wah Group of Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parents who have children aged 24 months to 3 years
Exclusion Criteria:
- Parents who have children beyond the above age range
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
Online curriculum has been delivered to this group of participants on an Internet-based platform
|
The psychologist and our advisory team had successfully developed a total of 100 hours of parenting curriculum. The adopted curriculum had focused on using play to facilitate parents in promoting their children's development in cognitive, motor, emotional and social aspects. Play-based activities are instrumental in improving children's development. Given that parents in poverty had difficulties spending time and money travelling back-and-forth to the training site and their homes, the research team decided to use e-learning as the medium of learning for our parenting programme. Web-based learning has the advantage of cutting time and travelling costs, which are luxuries to many parents in poverty. |
No Intervention: Wait-list control group
Participants in wait-list control group would not have access to the online curriculum until the intervention process for treatment group is finished.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bayley Scales of Infant and Toddler Development-III (Bayley III)
Time Frame: Change from baseline assessment at 10 months
|
It is a comprehensive tool to identify development issues during early childhood.
|
Change from baseline assessment at 10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ages and Stages Questionnaires (ASQ) and ASQ: SE
Time Frame: Change from baseline assessment at 10 months
|
It is a parent-report developmental screening tool. It covers the following aspects: Cognitive、Receptive Communication、Expressive Communication、Fine Motor、Gross Motor、Social-Emotion、Adaptive Behavior |
Change from baseline assessment at 10 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pauline Sung-Chan, Ph.D, Hong Kong Institute of Economics and Business Strategy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- early-childhood-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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