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A cluster-randomized controlled trial to measure the impact of a parenting intervention on child and parent outcomes in rural China
Last registered on September 25, 2018

Pre-Trial

Trial Information
General Information
Title
A cluster-randomized controlled trial to measure the impact of a parenting intervention on child and parent outcomes in rural China
RCT ID
AEARCTR-0003351
Initial registration date
September 25, 2018
Last updated
September 25, 2018 9:45 PM EDT
Location(s)
Primary Investigator
Affiliation
School of Advanced Agricultural Sciences, Peking University
Other Primary Investigator(s)
PI Affiliation
Center for Experimental Economics in Education, Shaanxi Normal University
PI Affiliation
Freeman Spogli Institute for International Studies, Stanford University
PI Affiliation
Center for Chinese Agricultural Policy, Chinese Academy of Sciences
Additional Trial Information
Status
Completed
Start date
2015-11-01
End date
2018-08-01
Secondary IDs
Abstract
Research has shown that young babies and children living in rural China are not reaching their full developmental potential. A 2013 survey of 2,000 rural (country-based) infants aged 6-12 months in Shaanxi Province, for example, showed that around 40% were significantly delayed in either their cognitive (thinking) or psychomotor (physical) development. Furthermore, rather than improving over time, the number of children suffering from developmental delays actually increased to 53% as the children became toddlers, indicating that rural children are falling further and further behind their healthy urban (town-based) counterparts. The Chinese Ministry of Health is aware of these numbers and is extremely concerned, as these infants represent nearly one-half of all those in China.
Why are rural Chinese children performing so poorly, and what can be done to solve this problem? A growing number of economic and psychology studies point to the importance of early childhood interventions (or programmes) for reaching childhood development milestones. The critical period before age two or three is considered to be a crucial “window”, during which interventions designed to improve cognitive development can have significant and lasting effects, even into adulthood. There is evidence to suggest that this critical developmental window is being ignored in rural China. Previous research suggests that only 13 percent of parents read or tell stories to their children. There is evidence that many rural Chinese babies live a life of silence, with minimal interaction with their adult caregivers. Indeed, many caregivers fully admit to not engaging with their young children as much as they might. “Why would I talk to her? She can’t understand me yet.” is a common response to questions about why they are not interacting with their children. Officials at China’s National Health & Family Planning Commission (NHFPC) have taken note of this issue, and are eager to take action. They have embraced the idea of village-based parenting centers as a way of bringing parental training into the areas most in need of assistance. The NHFPC has already committed both local cadres (i.e. government) and financial resources towards the parenting center project. Now, they have approached a research team to help them identify the best way in which to design and implement the village-based centers. The aim of this study is to identify the best way to develop these village-based parenting centers and measure the impact that these centers have on parental knowledge and behavior and, most importantly, on child development outcomes.
External Link(s)
Registration Citation
Citation
Luo, Renfu et al. 2018. "A cluster-randomized controlled trial to measure the impact of a parenting intervention on child and parent outcomes in rural China." AEA RCT Registry. September 25. https://doi.org/10.1257/rct.3351-1.0.
Former Citation
Luo, Renfu et al. 2018. "A cluster-randomized controlled trial to measure the impact of a parenting intervention on child and parent outcomes in rural China." AEA RCT Registry. September 25. https://www.socialscienceregistry.org/trials/3351/history/34838.
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
The project will be run as a randomized controlled trial with one intervention group and a control group with no intervention. Parenting centers will be based in a central location in each village, and all caregivers living in the village with children aged 6-24 months will be welcome to drop by at any time during regular operating hours. The parenting centers will be based in re-purposed office spaces that will be renovated to be child friendly (e.g. colorful walls, non-lead-based paint, soft floors). All parenting centers will include a central playroom, will be the same size, and have the same types of toys. 

The parenting curriculum that will be used in the parenting centers has been carefully developed according both to child development needs, and to the local environment in rural China. It consists of weekly interactive lessons targeting caregivers of babies aged 6 to 36 months (124 lessons total). Each month consists of activities (involving both caregivers and children) designed to teach caregivers how to interact with their children in ways that stimulate development in four dimensions considered essential by child development experts:
1. Cognitive
2. Motor
3. Language
4. Social-emotional development
This parenting curriculum has already undergone preliminary field testing and evaluation in rural China by our government partners at the National Health & Family Planning Commission (NHFPC) and our own evaluation team. It is loosely based on the “Jamaica curriculum” developed by Sally Grantham-McGregor and adapted to many different underdeveloped settings around the world, but it is fully designed and developed for a rural Chinese population, and is owned and copyrighted by the NHFPC.
Work on the full-scale RCT should begin in November, 2015. It is anticipated the parenting intervention will continue for 21 months, through August, 2017. 

A sample of all households in the village with children aged 6-24 months will be selected for participation in the evaluation surveys. All data on primary outcomes will be collected from these households.
Intervention Start Date
2015-12-07
Intervention End Date
2018-06-08
Primary Outcomes
Primary Outcomes (end points)
1. Children’s cognitive, language and motor development (as measured by the Bayley Scales of Infant Development—BSID) 
2. Children’s social-emotional development (as measured by the Ages & Stages Questionnaire)

Measured prior to treatment assignment (baseline), and at the conclusion of all interventions (endline).
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The impacts of village-based parenting centers on child development will be tested through a cluster-randomized controlled trial. In this trial, 100 villages will be randomly selected and allocated between an intervention group (50 villages) and a control group (50 villages) with no intervention.

Parenting centers will be based in a central location in each village, and all caregivers living in the village with children aged 6-36 months will be invited to visit centers at any time during operating hours. The parenting centers will be based in repurposed office spaces that will be renovated to be child friendly (eg: colorful walls, non-lead-based paint, soft floors).

All parenting centers will include a central playroom, and will be the same size, and have the same types of toys. All parenting center toys will be split into two types: (1) large, “free play” toys such as a small climbing structure, hula hoops, big plastic bouncy balls, a toy drum set, etc.; and (2) smaller toys associated with a week-by-week parenting curriculum (henceforth, “curriculum toys”).

The parenting curriculum that will be used in the parenting centers has been carefully developed according both to child development needs, and to the local environment in rural China. It consists of weekly interactive training courses targeting caregivers of babies aged 6 to 36 months (124 training courses total). Each month consists of activities (involving both caregivers and children) designed to teach caregivers how to interact with their children in ways that stimulate development in four dimensions considered essential by child development experts: a.) cognitive, b.) psychomotor, c.) language, and d.) social-emotional development. This parenting curriculum is fully designed and developed for a rural Chinese population and has already undergone preliminary field testing and evaluation in rural China by NHFPC and the research team.

Each center will have two staff members: a full-time center monitor, and a parenting instructor. The full-time center monitor will be a local villager who manages the center and takes care of day to day maintenance, such as regular disinfecting of the toys, tidying up, ensuring caregiver and child adherence to center rules, etc. The monitor will also run daily reading programs and assist the parenting instructor as needed. The parenting instructor will be a government worker from the township-level Health & Family Planning Commission (Local HFPC). He or she will undergo comprehensive training in child development and in the implementation of the NHFPC parenting curriculum by the Training & Communication Center of the NHFPC. Once a week, the parenting instructor will teach local caregivers the stage-based (age-appropriate) curriculum-based activity of the week. The parenting instructors’ goal is to teach caregivers how to interact with their child in such a way as to foster the child’s motor skills, cognition, language ability, and social-emotional development.
Experimental Design Details
Randomization Method
Randomization done in office by a computer
Randomization Unit
Village level randomization
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
We included 100 village clusters with 12 participating households on average per village.
Sample size: planned number of observations
100 villages will be randomly selected and allocated between an intervention group (50 villages) and a control group (50 villages) with no intervention. In total, allowing for attrition, we expect to enroll 1000 households in the study, amounting to around 2000 individuals (1000 caregivers + 1000 children).
Sample size (or number of clusters) by treatment arms
100 villages will be randomly selected and allocated between an intervention group (50 villages) and a control group (50 villages) with no intervention.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
To determine the sample size required, we performed power calculations using Optimal Design software. We calibrated the model as appropriate for a Cluster Randomized Trials with a continuous outcome (scores on both the Bayley Scales of Infant Development) and clustering at the village level. The power needed to detect a difference in outcome variables between the treatment and control groups in a Cluster Randomized Trial with a continuous outcome depends on 5 factors: a.) the number of babies per township (n); b.) the number of townships (J); c.) the intra-township correlation in outcome variable (ρ); d.) the minimum effect size that we would expect to be able to detect (δ); and e.) the proportion of variation in the true township-level post-intervention outcome variable explained by township-level pre-intervention outcome variable (R2). Based on our previous study of a household-based parenting intervention (also conducted in poor, rural areas of Shaanxi Province) we assume there will be on average 12 babies aged 6-24 months in each village at endline taking into account attrition from the sample over the study period, R2=0.5, and an intra-cluster correlation of 0.1. Based on these parameters, we estimate that we require 50 villages per arm to detect a 0.2 standard deviation effect on cognitive scores with 80% power at a significance level (α) of 0.05.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Stanford University Institutional Review Board Protocol
IRB Approval Date
2015-11-15
IRB Approval Number
6208
Analysis Plan

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Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
Yes
Intervention Completion Date
June 08, 2018, 12:00 AM +00:00
Is data collection complete?
Yes
Data Collection Completion Date
Final Sample Size: Number of Clusters (Unit of Randomization)
Was attrition correlated with treatment status?
Yes
Final Sample Size: Total Number of Observations
Final Sample Size (or Number of Clusters) by Treatment Arms
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers