Early Childhood DevelopmentECIINCT04512352
An Early Childhood Internet-based and Family-based Intervention Study
A study testing Online curriculum in people with Early Childhood Development, run by The University of Hong Kong at 6 sites in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Development
- What is being tested?
- Online curriculum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 6 sitesHong Kong
- Study dates
- 1 Nov 2017to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents who have children enrolled in the first year of Hong Kong nurseries ("N1"), mostly aged 24 months to 3 years
Who cannot join
- Parents who do not have children enrolled in the first year of Hong Kong nurseries ("N1")
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Hong Kong6 sites
Hong Kong Christian Service
Hong Kong
Hong Kong Lutheran Social Service
Hong Kong
Hong Kong Young Women's Christian Association
Hong Kong
Po Leung Kuk
Hong Kong
The Salvation Army
Hong Kong
Tung Wah Group of Hospitals
Hong Kong
About this study
Official title: 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.
Read more
The primary objective is to evaluate an internet- and family-based intervention to promote the development of children in poverty enrolled in the first year of Hong Kong's nurseries, who are mostly aged 24 months to three years. The examined outcomes will be the developmental well-being of participating children and parenting attitudes and behaviors, 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.
Read the detailed description
The proposed research consists of three phases. The first phase will be a cross-sectional survey with a sample of 1,000 cases from 60 nurseries cum kindergartens to explore the family demographics and developmental profiles of low-income children in comparison to others. The second phase will be a randomized control trail implementing two waves of a 10-month internet-based intervention with 200 toddler-parents dyads from 20 to 30 of the original 60 nurseries. Interventions will be delivered by older mentors professionally trained by the research team. All children, parents and elderly mentors will be evaluated through a set of outcome measurements to assess the effectiveness of the program. The last phase will involve the dissemination of research information that may become building blocks for policies on internet-based early childhood education, poverty alleviation and social mobility enhancement, as well as productive aging.
- Conditions
- Early Childhood Development
- Being tested
- Online curriculum
- Keywords
- Social mobility & poverty, Internet & family-based, Early childhood intervetion, Intergenerational, Productive aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online curriculumOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Online curriculum has been delivered to this group of participants on an Internet-based platform Receives: Other: Online curriculum |
| Wait-list control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Bayley Scales of Infant and Toddler Development- Third Edition
Bayley-III is a comprehensive tool to identify development issues during early childhood through direct assessment of the child. Domains include: Cognitive, Receptive Communication, Expressive Communication, Fine Motor, Gross Motor. The minimum scaled score is 1 and maximum scaled score is 19. A higher score means a better outcome.
Measured: Change from baseline assessment at 10 months
Secondary outcomes (4)
Parenting Sense of Competence Scale- Chinese
Parenting Sense of Competence Scale- Chinese (C-PSOC) was used to measure parenting sense of competence and satisfaction. The minimum score is 17 and the maximum score is 102. A higher score means a better outcome.
Measured: Change from baseline assessment at 10 months
Chinese version of the Parental Feeding Style Questionnaire
A Chinese version of the parental feeding style questionnaire (PFSQ; Tam et al., 2014) was used, which covers: (1) instrumental feeding; (2) emotional feeding; (3) promoting and encouraging of feeding; and (4) control over children's eating. The minimum score is 27 and the maximum score is 135. A higher score means a better outcome.
Measured: Change from baseline assessment at 10 months
Connor-Davidson Resilience Scale 10-item
Connor-Davidson Resilience Scale 10-item version (CD-RISC-10) was used to assess parents' resilience. The minimum score is 10 and the maximum score is 50. A higher score means a better outcome.
Measured: Change from baseline assessment at 10 months
The Multidimensional Scale of Perceived Social Support-Chinese
The Multidimensional Scale of Perceived Social Support-Chinese Version (MSPSS-C) was used which measured the social support network of and support from friends, and perceived social support from family from parents' perspectives. The minimum score is 12 and the maximum score is 84. A higher score means a better outcome.
Measured: Change from baseline assessment at 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Nov 2017
- Primary completion31 May 2020
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood DevelopmentStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Large-scale survey: Using the stratified sampling method, a randomized list of 60 samples was selected from the official list of 506 kindergartens-cum-child care center provided by the Bureau of Education. Out of the 60 schools, a total of 40 schools from 12 NGOs agreed to join the survey. As of April 2019, we have received 700 responses for the survey. Intervention Study: There are two phases of intervention in this stage. The total sample size for both phases is 200 parent-child dyads. For both phases, the team applied stratified randomization method for randomization. Participants were assigned to either treatment group or wait-list control group on a school basis.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline Sung-Chan, Ph.D, Principal investigator, Hong Kong Institute of Economics and Business Strategy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512352
- Sponsor's protocol ID
- early-childhood-2020
- Acronym
- ECII
- Status last verified
- Aug 2020
- First submitted
- 15 May 2020
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD shall be released ten years upon the completion of this project. For research purpose only, interested parties shall write to us to get the data.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Large Scale Cross-sectional Survey and a Randomized Control Study on the Effectiveness of an Early Childhood Family-Based and Internet-Based Intervention
- ClinicalTrials.gov ID
- NCT04512352
- Acronym / sponsor ID
- ECII / early-childhood-2020
- Conditions
- Early Childhood Development
- Keywords
- Social mobility & poverty, Internet & family-based, Early childhood intervetion, Intergenerational, Productive aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 enrolled in the first year of Hong Kong's nurseries, who are mostly aged 24 months to three years. The examined outcomes will be the developmental well-being of participating children and parenting attitudes and behaviors, 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.
Detailed description
The proposed research consists of three phases. The first phase will be a cross-sectional survey with a sample of 1,000 cases from 60 nurseries cum kindergartens to explore the family demographics and developmental profiles of low-income children in comparison to others. The second phase will be a randomized control trail implementing two waves of a 10-month internet-based intervention with 200 toddler-parents dyads from 20 to 30 of the original 60 nurseries. Interventions will be delivered by older mentors professionally trained by the research team. All children, parents and elderly mentors will be evaluated through a set of outcome measurements to assess the effectiveness of the program. The last phase will involve the dissemination of research information that may become building blocks for policies on internet-based early childhood education, poverty alleviation and social mobility enhancement, as well as productive aging.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Large-scale survey: Using the stratified sampling method, a randomized list of 60 samples was selected from the official list of 506 kindergartens-cum-child care center provided by the Bureau of Education. Out of the 60 schools, a total of 40 schools from 12 NGOs agreed to join the survey. As of April 2019, we have received 700 responses for the survey. Intervention Study: There are two phases of intervention in this stage. The total sample size for both phases is 200 parent-child dyads. For both phases, the team applied stratified randomization method for randomization. Participants were assigned to either treatment group or wait-list control group on a school basis.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Online curriculumOnline curriculum has been delivered to this group of participants on an Internet-based platform |
| Wait-list control group | No intervention | –Participants in wait-list control group would not have access to the online curriculum until the intervention process for treatment group is finished. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parents who have children enrolled in the first year of Hong Kong nurseries ("N1"), mostly aged 24 months to 3 years
Key exclusion criteria (1 listed)
- Parents who do not have children enrolled in the first year of Hong Kong nurseries ("N1")
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online curriculumThe 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. | Other | Treatment group |
Primary outcome
Bayley Scales of Infant and Toddler Development- Third Edition
Time frame: Change from baseline assessment at 10 months
Bayley-III is a comprehensive tool to identify development issues during early childhood through direct assessment of the child. Domains include: Cognitive, Receptive Communication, Expressive Communication, Fine Motor, Gross Motor. The minimum scaled score is 1 and maximum scaled score is 19. A higher score means a better outcome.
4 secondary outcomes
Parenting Sense of Competence Scale- Chinese
Time frame: Change from baseline assessment at 10 months
Chinese version of the Parental Feeding Style Questionnaire
Time frame: Change from baseline assessment at 10 months
Connor-Davidson Resilience Scale 10-item
Time frame: Change from baseline assessment at 10 months
The Multidimensional Scale of Perceived Social Support-Chinese
Time frame: Change from baseline assessment at 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Yes. IPD shall be released ten years upon the completion of this project. For research purpose only, interested parties shall write to us to get the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline Sung-Chan, Ph.D principal investigator
Hong Kong Institute of Economics and Business Strategy
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online curriculum in people with Early Childhood Development, run by The University of Hong Kong at 6 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley Scales of Infant and Toddler Development- Third Edition (time frame: Change from baseline assessment at 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.