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Cluster Randomised Controlled Trial of the effectiveness of comprehensive early childhood development (CECD) services in rural areas, China
Last registered on September 25, 2018

Pre-Trial

Trial Information
General Information
Title
Cluster Randomised Controlled Trial of the effectiveness of comprehensive early childhood development (CECD) services in rural areas, China
RCT ID
AEARCTR-0003316
Initial registration date
September 20, 2018
Last updated
September 25, 2018 3:56 PM EDT
Location(s)

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Primary Investigator
Affiliation
School of Advanced Agricultural Sciences, Peking University
Other Primary Investigator(s)
Additional Trial Information
Status
On going
Start date
2018-08-01
End date
2019-12-31
Secondary IDs
Abstract
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.

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).
External Link(s)
Registration Citation
Citation
Luo, Renfu. 2018. "Cluster Randomised Controlled Trial of the effectiveness of comprehensive early childhood development (CECD) services in rural areas, China." AEA RCT Registry. September 25. https://doi.org/10.1257/rct.3316-1.0.
Former Citation
Luo, Renfu. 2018. "Cluster Randomised Controlled Trial of the effectiveness of comprehensive early childhood development (CECD) services in rural areas, China." AEA RCT Registry. September 25. https://www.socialscienceregistry.org/trials/3316/history/34804.
Experimental Details
Interventions
Intervention(s)
We will implement the intervention in each of our 50 treatment natural villages. During the weekly home visiting, 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 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.
Intervention Start Date
2018-09-18
Intervention End Date
2019-09-18
Primary Outcomes
Primary Outcomes (end points)
1. Test scores of Caregiver Reported Early Childhood Development Instruments (CREDI) and Bayley Scales of Infant Development (BSID) increased;
2. Number of children delayed in cognitive, language, motor and social-emotion development decreased.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
Cluster randomized controlled trial with one control group and one treatment group. A sample of 100 villages containing 690 babies aged 6-24 months.
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 child's performance.
Experimental Design Details
Not available
Randomization Method
Randomization is done at the office using STATA on a computer.
Randomization Unit
Natural village level randomization
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
100 natural villages (clusters), 50 in treatment and 50 in control.
Sample size: planned number of observations
The total sample sizes will be 690 families with children who were a part of the initial phase of the trial, 336 of them from 50 villages will be distributed as treatment.
Sample size (or number of clusters) by treatment arms
50 villages in treatment group and 50 villages in control group. In sum, 100 villages.
25 caregiver service providers will be trained and arranged in treatment group and no service providers in control group. 336 children in intervention group and 354 in control group will be directly measured.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Peking University Institutional Review Board (PUIRB)
IRB Approval Date
2017-07-04
IRB Approval Number
IRB00001052-17056