Lower Socioeconomic BackgroundKSJCNCT03615937
KeySteps@JC - Early Child Intervention
A study testing Child interactive intervention, Family Empowerment and Access to Community Hub and its services in people with Lower Socioeconomic Background, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Socioeconomic Background
- What is being tested?
- Child interactive intervention, Family Empowerment and Access to Community Hub and its services
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,216 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2018to 31 Jul 2022
- 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 2 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- K1 children [~3 years], with a selected Pre-Nursery group [~2 years], and their families attending participating kindergartens.
- Kindergartens located at Sham Shui Po and Tin Shui Wai districts in Hong Kong based on the following criteria:
- Full-day program
- Pre-Primary Education Voucher Scheme
- Basic school facilities (minimally >1 classroom and a basic activity room available)
- Average school tuition fee in the past 5 years (<HKD 40,000)
- Proportion of teachers with early childhood education bachelor degrees or above. Teachers of participating children will be their facilitators/assessors in this study.
Who cannot join
- Children and families from non-participating kindergartens; children below and above K1 (except for a selected Pre-Nursery group).
- Non-English/Chinese speaking subjects.
- Teachers of non-participating children and kindergartens.
- Non-consenting subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: KeySteps@JC - Early Child Intervention for Underprivileged Families in Hong Kong
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.
Read the 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.
- Conditions
- Lower Socioeconomic Background
- Being tested
- Child interactive intervention, Family Empowerment, Access to Community Hub and its services, Enhancement to the kindergartens, Health education, screening, and support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child interactive interventionBehavioural
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 EmpowermentBehavioural
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.
Access to Community Hub and its servicesBehavioural
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.
Enhancement to the kindergartensOther
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 education, screening, and supportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Intervention | Experimental | 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 Receives: Behavioral: Child interactive intervention; Behavioral: Family Empowerment; Behavioral: Access to Community Hub and its services; Other: Enhancement to the kindergartens; Other: Health education, screening, and support |
| Health Support | Active comparator | This is a control arm with only health components.
1. Health education, screening, and support Receives: Other: Health education, screening, and support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child development
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.
Measured: Three years after start of intervention
Secondary outcomes (7)
Physical health and well-being
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
Measured: Three years after start of intervention
Socio-emotional development
Aggregated score based on validated tools such as Strength and Difficulties Questionnaires and Chinese Early Development Instrument using principal component analysis
Measured: Three years after start of intervention
Neurocognitive development
Aggregated score based on validated tools such as Hong Kong Early Child Development Scale and Parents' Evaluation of Developmental Status using principal component analysis
Measured: Three years after start of intervention
Parental Capacity and Parenting Practices
Aggregated score based on validated tools such as Parent-child Conflict Tactics Scale using principal component analysis
Measured: Three years after start of intervention
Parenting and developmental literacy
Aggregated score based on validated tools such as Parent-Child Interaction Scale, Parenting Styles and Dimensions Questionnaire using principal component analysis
Measured: Three years after start of intervention
Parental mental health and emotion processing
Aggregated score based on validated tools, such as General Self-Efficacy Scale, Connor Davidson Resilience Scale using principal component analysis
Measured: Three years after start of intervention
School readiness
Total scale score of the Chinese Early Development Instrument using principal component analysis
Measured: Three years after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Oct 2018
- Primary completion30 Sep 2021
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Socioeconomic BackgroundStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Ip, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615937
- Sponsor's protocol ID
- KeySteps@JC
- Acronym
- KSJC
- Status last verified
- Jan 2023
- First submitted
- 16 Jul 2018
- Last updated
- 19 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35129606
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KeySteps@JC - Early Child Intervention for Underprivileged Families in Hong Kong
- ClinicalTrials.gov ID
- NCT03615937
- Acronym / sponsor ID
- KSJC / KeySteps@JC
- Conditions
- Lower Socioeconomic Background
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,216 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 6 Aug 2018 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Intervention | Experimental | Behavioral: Child interactive intervention, Behavioral: Family Empowerment, Behavioral: Access to Community Hub and its services, Other: Enhancement to the kindergartens, Other: Health education, screening, and supportThis 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 | Active comparator | Other: Health education, screening, and supportThis is a control arm with only health components. 1. Health education, screening, and support |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- K1 children [~3 years], with a selected Pre-Nursery group [~2 years], and their families attending participating kindergartens.
- Kindergartens located at Sham Shui Po and Tin Shui Wai districts in Hong Kong based on the following criteria:
Key exclusion criteria (4 listed)
- Children and families from non-participating kindergartens; children below and above K1 (except for a selected Pre-Nursery group).
- Non-English/Chinese speaking subjects.
- Teachers of non-participating children and kindergartens.
- Non-consenting subjects.
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 |
|---|---|---|
| Child interactive interventionThe 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. | Behavioural | Comprehensive Intervention |
| Family EmpowermentFamily 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. | Behavioural | Comprehensive Intervention |
| Access to Community Hub and its servicesA 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. | Behavioural | Comprehensive Intervention |
| Enhancement to the kindergartensThis 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. | Other | Comprehensive Intervention |
| Health education, screening, and supportHealth 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. | Other | Comprehensive Intervention, Health Support |
Primary outcome
Child development
Time frame: 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.
7 secondary outcomes
Physical health and well-being
Time frame: Three years after start of intervention
Socio-emotional development
Time frame: Three years after start of intervention
Neurocognitive development
Time frame: Three years after start of intervention
Parental Capacity and Parenting Practices
Time frame: Three years after start of intervention
Parenting and developmental literacy
Time frame: Three years after start of intervention
Parental mental health and emotion processing
Time frame: Three years after start of intervention
School readiness
Time frame: Three years after start of intervention
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 19 Jan 2023.
- Derived from this study: PubMed 35129606Leung 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.
- Individual participant dataSharing planned: No
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.
Patrick Ip principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Child interactive intervention, Family Empowerment and Access to Community Hub and its services in people with Lower Socioeconomic Background, run by The University of Hong Kong at 1 site 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 7 inclusion and 4 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 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Child development (time frame: Three years after start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03615937, which also lists 1 linked publication.
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 19 Jan 2023.