Plain English Summary
Background and study aims
A growing number of studies point to the importance of early childhood intervention for fulfilling childhood development potential. The critical period before age three is considered to be a crucial “window”, during which interventions designed to improve child development can have significant and lasting effects, even into adulthood. Moreover, intervention during this time period is considered to be the most cost-effective from a policy perspective.
This project seeks to explore the most cost-effective interventions and associated implementation protocols to help to young babies and children living in rural China to reach their full developmental potentials. To do so, we propose to conduct a large-scale randomized controlled trial to measure the impact of a Comprehensive Early Childhood Development (CECD) intervention on parental knowledge, attitude, behavior and, most importantly, on child development outcomes.
Who can participate?
Children aged between 6 and 24 months from the 50 villages involved can participate.
What does the study involve?
We plan to work together with social institutions and local government, empower them with training sessions so that they can serve as competent CECD service providers (i.e. parenting instructors), and make up for the commercial and social deficiencies in rural areas. The parenting instructors will visit treatment group during weekly home visiting, demonstrate and guide these parents (caregivers) how to play and interact with the babies to help the development of cognition, language, motor and social emotion by using the week-by-week parenting curriculum and toys (or picture books).
What are the possible benefits and risks of participating?
Participants may benefit from improved neurodevelopment and quality of life. There will be no risk for participants to be part of this trial, according to our study design.
Where is the study run from?
1. China Center for Agricultural Policy - Peking University
2. School of Economics and Management - Jiangxi Agricultural University
When is the study starting and how long is it expected to run for?
January 2018 to October 2018
Who is funding the study?
China Center for Agricultural Policy - Peking University, China.
Who is the main contact?
Prof. Renfu Luo,
luorf.ccap@pku.edu.cn
Trial website
Contact information
Type
Scientific
Primary contact
Prof Renfu Luo
ORCID ID
Contact details
Room 409
Wangkezhen Building
Peking University
No.5 Yiheyuan Road
Haidian District
Beijing
100871
China
0086-010-62760156
luorf.ccap@pku.edu.cn
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
AEARCTR-0003316
Study information
Scientific title
Cluster Randomised Trial of the effectiveness of comprehensive early childhood development (CECD) services in rural areas, China
Acronym
Study hypothesis
Early childhood stimulation and improved parental practices will have positive effects on a child's cognitive, language, motor and socioemotional development.
Ethics approval
Approved 04/07/2017, Peking University Institutional Review Board (PUIRB) (Room 501, Yifu Building, Peking University Medical Department, No. 38 College Road, Haidian District, Beijing, China; llwyh@bjmu.edu.cn; +86 010-82805751), ref: IRB00001052-17056
Study design
Cluster randomized controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Quality of life
Patient information sheet
No participant information sheet available
Condition
Child development
Intervention
We will implement the intervention in each of our 50 treatment villages. During the weekly home visits, the parenting instructors will demonstrate and guide the parents (caregivers) how to play and interact with the babies to help the development of cognition, language, motor and social emotion by using the week-by-week parenting curriculum and toys (or picture books). After that, the parenting instructors will tell the parents (caregivers) nutrition and health knowledge for the child at that age. And finally the parenting instructors will give the curriculum and toys of the week to the family and collect the curriculum and toys used last week.
The initial phase of the trial has two data collection rounds: a baseline survey (completed) and one at endline. These data include detailed family characteristics and parental characteristics that will allow us to understand the heterogeneity of outcomes for different groups, plus a ten-minute video for each of our treatment household recording the interaction between the child and caregiver. We will videotape during both baseline and endline survey to observe subtle changes in terms of the quality of interaction as well as the child's performance.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Test scores of Caregiver Reported Early Childhood Development Instruments (CREDI) and Bayley Scales of Infant Development (BSID) at baseline and follow-up (50-weeks).
2. Number of children delayed in cognitive, language, motor and social-emotion development at follow-up (measured using the above tools)
Secondary outcome measures
1. Changes in parenting practices and parental adjustment, assessed from reports of mothers using Parenting and Family Adjustment Scales (PAFAS) from baseline to follow-up.
2. Parental knowledge of normative infant development, assessed using Knowledge of Infant Development Inventory (KIDI) from baseline to follow-up.
3. Aspects of the quality and quantity of psychological stimulation and cognitive support available in the home environment, assessed using the Home Observation for Measurement of the Environment Inventory (HOME) from baseline to follow-up.
4. Parenting Pressure measured by Parenting Depression Index (PD) from baseline to follow-up.
Overall trial start date
01/08/2018
Overall trial end date
31/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children aged between 6 and 24 months
2. Able and willing to cooperate with the examination
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
Total sample size is 690 families with children who were in our desired age range (6-24 mo)
Participant exclusion criteria
1. Parents do not consent
Recruitment start date
08/01/2018
Recruitment end date
08/10/2018
Locations
Countries of recruitment
China
Trial participating centre
China Center for Agricultural Policy - Peking University
Wangkezhen Building
Peking University
No.5 Yiheyuan Road
Haidian District
Beijing
100871
China
Trial participating centre
School of Economics and Management - Jiangxi Agricultural University
1101 Zhimin Avenue
Qingshanhu Economic and Technological Development Zone
Nanchang
Jiangxi
330045
China
Sponsor information
Organisation
UBS Optimus Foundation
Sponsor details
Room 1119
Yinglan International Financial Center
Financial Street 7th
Xicheng District
Beijing
100034
China
+86 21 3866 8051
joco.hu@ubs.com
Sponsor type
Charity
Website
https://www.ubs.com/microsites/optimus-foundation/en.html
Organisation
National Natural Science Foundation of China
Sponsor details
83 Shuangqing Road
Haidian District
Beijing
100085
China
86-10-62327001
bic@nsfc.gov.cn
Sponsor type
Research council
Website
Organisation
Union Bank of Switzerland
Sponsor details
Sponsor type
Not defined
Website
Funders
Funder type
University/education
Funder name
China Center for Agricultural Policy, Peking University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
31/12/2020
Participant level data
Other
Basic results (scientific)
Publication list