- 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 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.
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
-
Hong Kong, Hong Kong
- Hong Kong Lutheran Social Service
-
Hong Kong, Hong Kong
- Hong Kong Young Women's Christian Association
-
Hong Kong, Hong Kong
- Po Leung Kuk
-
Hong Kong, Hong Kong
- The Salvation Army
-
Hong Kong, Hong Kong
- Tung Wah Group of Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parents who have children enrolled in the first year of Hong Kong nurseries ("N1"), mostly aged 24 months to 3 years
Exclusion Criteria:
- Parents who do not have children enrolled in the first year of Hong Kong nurseries ("N1")
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- 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.
|
Change from baseline assessment at 10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parenting Sense of Competence Scale- Chinese
Time Frame: Change from baseline assessment at 10 months
|
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.
|
Change from baseline assessment at 10 months
|
|
Chinese version of the Parental Feeding Style Questionnaire
Time Frame: Change from baseline assessment at 10 months
|
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.
|
Change from baseline assessment at 10 months
|
|
Connor-Davidson Resilience Scale 10-item
Time Frame: Change from baseline assessment at 10 months
|
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.
|
Change from baseline assessment at 10 months
|
|
The Multidimensional Scale of Perceived Social Support-Chinese
Time Frame: Change from baseline assessment at 10 months
|
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.
|
Change from baseline assessment at 10 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Ages and Stages Questionnaires (ASQ) -3 (Third Edition)
Time Frame: Change from baseline assessment at 10 months
|
This scale is parent-reported and measures child development.
It covers the following aspects: Communication, gross motor skills, fine motor skills, problem-solving, and personal-social skills.
The minimum score is 0 and the maximum score is 300.
A higher score means a better outcome.
|
Change from baseline assessment at 10 months
|
|
Ages and Stages Questionnaire: Social-Emotional- 2 (Second Edition)
Time Frame: Change from baseline assessment at 10 months
|
This scale is parent-reported and measures child development.
This scale assesses social-emotional competence and challenging behaviors.
The minimum score is 0 and the maximum score is 540.
A higher score means a worse outcome.
|
Change from baseline assessment at 10 months
|
|
Strengths and Difficulties Questionnaire
Time Frame: Change from baseline assessment at 10 months
|
This scale is parent-reported and measures child development.
It assesses parent's perception of children's behavioral problems, including emotional symptoms, conduct problems, hyperactivity/inattention, peer relationships problem, and prosocial behavior.
Each domain's minimum score is 0 and maximum is 10.
For all domains except for prosocial behavior, a higher score means a worse outcome.
For the prosocial behavior domain, a higher score means a better outcome.
|
Change from baseline assessment at 10 months
|
|
Bayley Scales of Infant and Toddler Development- Third Edition: Social-Emotional
Time Frame: Change from baseline assessment at 10 months
|
This scale is parent-reported and measures child development.
Social-Emotional has 35 items.
The minimum score is 0 and maximum score is 140.
A higher score means a better outcome.
|
Change from baseline assessment at 10 months
|
|
Bayley Scales of Infant and Toddler Development- Third Edition: Adaptive Behavior
Time Frame: Change from baseline assessment at 10 months
|
This scale is parent-reported and measures child development.
Adaptive Behavior includes 10 domains: Communication (25 items), Community Use (22-items), Functional Pre-Academics (23-items), Home Living (25-items), Health and Safety (24-items), Leisure (22-items), Self-Care (24-items), Self-Direction (25-items), Social (24-items), Motor Skills (27-items).
The minimum score for the Adaptive Behavior composite is 0 and the maximum is 723.
A higher score means a better outcome.
|
Change from baseline assessment at 10 months
|
|
The General Functioning Subscale of the McMaster Family Assessment Device
Time Frame: Change from baseline assessment at 10 months
|
The General Functioning Subscale of the McMaster Family Assessment Device (Epstein, Baldwin, and Bishop, 1983) was used to measure the family functioning.
The minimum score is 12 and the maximum score is 48.
The higher the score, the worse the outcome.
|
Change from baseline assessment at 10 months
|
|
Parenting Stress Index - Short Form
Time Frame: Change from baseline assessment at 10 months
|
PSI-SF was used to measure stress, which includes sub-scales: parental distress, parent-child dysfunctional interaction, and difficult child.
The minimum score is 36 and the maximum score is 180.
A higher score means a worse outcome.
|
Change from baseline assessment at 10 months
|
|
The Depression, Anxiety and Stress Scale - 21 Items
Time Frame: Change from baseline assessment at 10 months
|
DASS-21 was used to measure depression, anxiety and stress.
The minimum score is 0 and the maximum score is 63.
A higher score means a worse outcome.
|
Change from baseline assessment at 10 months
|
|
Interpersonal Mindfulness in Parenting (IEMP) scale, Chinese version
Time Frame: Change from baseline assessment at 10 months
|
IEMP was used to measure parental mindfulness, which has subscales: awareness & present-centered attention, non-judgment, and non-reactivity.
The minimum score is 31 and the maximum score is 155.
A higher score means a better outcome.
|
Change from baseline assessment at 10 months
|
|
Psychological and Behavioral Control
Time Frame: Change from baseline assessment at 10 months
|
This Chinese scale was originally developed by Dr. Daniel Shek (2006) and was adapted by the research team from adolescent-reported to parent-reported to assess levels of parental psychological control and behavioral control of their children.
The minimum score is 23 and the maximum score is 92.
The higher the score, the worse the outcome.
|
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 (Actual)
Study Completion (Actual)
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.
Clinical Trials on Early Childhood Development
-
Yale UniversityMassachusetts Institute of Technology; Jameel (Abdul Latif) Poverty Action... and other collaboratorsCompleted
-
Boston UniversityUnited States Agency for International Development (USAID); Swiss Tropical... and other collaboratorsCompletedEarly Childhood DevelopmentZambia
-
Stanford UniversityJohns Hopkins University; University of California, Berkeley; International Centre... and other collaboratorsCompletedEarly Childhood DevelopmentBangladesh
-
Duke UniversityCatholic Relief ServicesCompleted
-
University of California, BerkeleyUniversity of Nevada, Reno; World BankCompletedEarly Childhood DevelopmentMadagascar
-
Bartosz M. RadtkeRecruitingChild Development | Infant Development | Early Childhood DevelopmentPoland
-
Mathematica Policy Research, Inc.The University of Texas Health Science Center, Houston; Department of Health... and other collaboratorsUnknownEarly Childhood Professional DevelopmentUnited States
-
University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsNot yet recruiting
-
Mathematica Policy Research, Inc.University of Oklahoma; Department of Health and Human Services; Zero to ThreeUnknownEarly Childhood Professional Development
-
Chang Gung Memorial HospitalActive, not recruitingEarly Childhood Development (ECD)Taiwan
Clinical Trials on Online curriculum
-
University of OttawaCompletedMental Disorders | Adolescents | Early Intervention | Comparative Effectiveness Research | Education Curriculum
-
Mayo ClinicCompleted
-
Penn State UniversityNational Institute on Drug Abuse (NIDA); Ohio State UniversityCompleted
-
Johns Hopkins Bloomberg School of Public HealthFogarty International Center of the National Institute of HealthWithdrawnSelf Efficacy | Behavior ChangePakistan
-
University of ChicagoActive, not recruitingLanguage Environments of Children of Low-socioeconomic StatusUnited States
-
University Hospitals Cleveland Medical CenterAmerican Academy of Pediatrics; Mt. Sinai Health Care FoundationCompleted
-
Brigham and Women's HospitalJohns Hopkins University; Massachusetts General Hospital; Washington University... and other collaboratorsCompletedResident Knowledge and Attitudes Regarding Cross-cultural Care | Interpersonal and Communication Skills in Patient-clinician Encounters | Patient-reported Satisfaction With Resident Physicians Involved in Their Care | Patients' Clinical Health Outcomes After SurgeryUnited States
-
Weill Medical College of Cornell UniversityCompletedPediatric Residents Rotating in Pediatric OncologyUnited States
-
Stanford UniversityNot yet recruitingEnvironmental Exposure | Attitude | Health Knowledge | PracticeUnited States
-
University of ChicagoNational Institute on Minority Health and Health Disparities (NIMHD); University... and other collaboratorsRecruitingCOVID-19 | Influenza | Health Behavior | Communication Research | Respiratory Viral InfectionUnited States