Testing the effectiveness of comprehensive early childhood development (CECD) services in rural areas of China

ISRCTN	ISRCTN43795285
DOI	https://doi.org/10.1186/ISRCTN43795285
Secondary identifying numbers	AEARCTR-0003316

Submission date: 06/05/2019
Registration date: 17/05/2019
Last edited: 03/06/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Renfu Luo
Scientific

Room 409
Wangkezhen Building
Peking University
No.5 Yiheyuan Road
Haidian District
Beijing
100871
China

Phone	0086-010-62760156
Email	luorf.ccap@pku.edu.cn

Study information

Study design	Cluster randomized controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Community
Study type	Quality of life
Participant information sheet	No participant information sheet available
Scientific title	Cluster Randomised Trial of the effectiveness of comprehensive early childhood development (CECD) services in rural areas, China
Study objectives	Early childhood stimulation and improved parental practices will have positive effects on a child's cognitive, language, motor and socioemotional development.
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	01/08/2018
Completion date	31/12/2019

Eligibility

Participant type(s)	Healthy volunteer
Age group	Child
Lower age limit	6 Months
Upper age limit	24 Months
Sex	Both
Target number of participants	Total sample size is 690 families with children who were in our desired age range (6-24 mo)
Total final enrolment	635
Key inclusion criteria	1. Children aged between 6 and 24 months 2. Able and willing to cooperate with the examination
Key exclusion criteria	1. Parents do not consent
Date of first enrolment	08/01/2018
Date of final enrolment	08/10/2018

Locations

Countries of recruitment

China

Study participating centres

China Center for Agricultural Policy - Peking University

Wangkezhen Building
Peking University
No.5 Yiheyuan Road
Haidian District
Beijing
100871
China

School of Economics and Management - Jiangxi Agricultural University

1101 Zhimin Avenue
Qingshanhu Economic and Technological Development Zone
Nanchang
Jiangxi
330045
China

Sponsor information

UBS Optimus Foundation
Charity

Room 1119
Yinglan International Financial Center
Financial Street 7th
Xicheng District
Beijing
100034
China

Phone	+86 21 3866 8051
Email	joco.hu@ubs.com
Website	https://www.ubs.com/microsites/optimus-foundation/en.html

National Natural Science Foundation of China
Research council

83 Shuangqing Road
Haidian District
Beijing
100085
China

Phone	86-10-62327001
Email	bic@nsfc.gov.cn
Website	http://www.nsfc.gov.cn/

Funders

Funder type

University/education

China Center for Agricultural Policy, Peking University

No information available

Results and Publications

Intention to publish date	31/12/2020
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/10/2020	03/06/2021	Yes	No

Editorial Notes

03/06/2021: Publication reference and total final enrolment added.
16/05/2019: Trial’s existence confirmed by Peking University Institutional Review Board.