A study of the effectiveness, scalability, and sustainability of early childhood development services in rural China

Last registered on June 21, 2024

Pre-Trial

Trial Information

General Information

Title
A study of the effectiveness, scalability, and sustainability of early childhood development services in rural China
RCT ID
AEARCTR-0010078
Initial registration date
September 17, 2022

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
September 19, 2022, 4:29 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
June 21, 2024, 3:36 AM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

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Primary Investigator

Affiliation
Southwestern University of Finance and Economics

Other Primary Investigator(s)

PI Affiliation
Stanford University
PI Affiliation
Stanford University

Additional Trial Information

Status
In development
Start date
2022-10-10
End date
2025-02-01
Secondary IDs
ISRCTN84864201
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
A major cause of poor early childhood development (ECD) in developing countries is under-investment in psychosocial stimulation by caregivers, which is compounded by high rates of mental health issues among caregivers, such as depression and anxiety. The purpose of this study is to evaluate the effectiveness of an integrated intervention of parenting training and caregiver mental health promotion on child development outcomes and caregiver well-being among rural households in China. We will study whether a local-led program can effectively improve ECD and caregiver mental health outcomes among vulnerable communities; and whether an integrated ECD and caregiver mental health intervention can improve the impacts on child and caregiver outcomes.
External Link(s)

Registration Citation

Citation
Pappas, Lucy, Yiwei Qian and Scott Rozelle. 2024. "A study of the effectiveness, scalability, and sustainability of early childhood development services in rural China." AEA RCT Registry. June 21. https://doi.org/10.1257/rct.10078-1.1
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
The Project is a curriculum-based caregiver education intervention that aims to improve early childhood psychosocial development and maternal well-being through caregiver training classes by trainers. There are two curricula implemented in this intervention.

The parenting training curriculum was loosely based on the Reach Up and Learn curriculum and adapted by the research team in collaboration with early childhood development experts in China. Weekly stage-based, age-appropriate sessions were developed targeting children 6-36 months of age. Each weekly session contains modules focusing on two of four developmental modules: cognition, language, motor, and social-emotional skill development. At the end of each session, caregivers are encouraged to take toys and books home and to practice the activities at home daily. To maximize adherence, parenting trainers will conduct home visits to households that cannot visit the Center Centers. Parenting trainers will invite caregivers to attend one-on-one parenting training sessions at the child centers in the villages. To maximize adherence, parenting trainers will conduct home visits to households that cannot visit the Child Centers.

The mental health curriculum is adapted from the World Health Organization Thinking Healthy Programme, an evidence-based psychosocial intervention providing psychoeducation and coaching based on principles of cognitive behavioral therapy. Structured forms of talk therapy are used to disrupt and alter the cycle of unhealthy thinking (cognitions), leading to unhelpful emotions which can result in undesirable actions (behaviors). In a safe environment, caregivers are encouraged to voice their problems, share their experiences of childrearing, and receive social support, therefore improving their relationship with their children and with the people around them. Although the WHO-designed curriculum only covers the first ten months after childbirth, the outcome of other research has extended and implemented the curriculum for caregivers of children up to 3 years of age. In this study, we will adapt the curriculum to be culturally appropriate to rural households in rural China. For example, we will adjust the language in the sessions to make it more accessible to older and less-educated grandmother caregivers, who are typically responsible for taking care of left-behind children in rural areas. The caregiver mental health curriculum will be delivered in group-based workshops every two weeks at private and undisturbed locations in the villages.
Intervention Start Date
2022-11-21
Intervention End Date
2024-02-01

Primary Outcomes

Primary Outcomes (end points)
1. Early childhood development outcomes; 2. Mental health of caregivers (both primary and secondary)
Primary Outcomes (explanation)
Early childhood development outcomes are measured by the following scales: 1) Bayley Scales of Infant and Toddler Development, third edition (Bayley-III); 2) Caregiver Reported Early Development Instrument – short form (CREDI-SF); 3) Brief Infant-Toddler social and Emotional Assessment (BITSEA); 4) New Wolke social-Emotional Behavior Ratings.

Mental health of caregivers will be measured by the following scales: 1) Depression Anxiety Stress Scale, 21 items (DASS-21); 2) Patient Health Questionnaire (PHQ-9); 3) Center for Epidemiologic Studies Depression Scale (CES-D)

Secondary Outcomes

Secondary Outcomes (end points)
1. Parental investment in stimulative parenting practices and materials
2. Parenting style
3. Social connectedness between caregiver and trainers, and between caregivers and other caregivers
4. Structural and functional social support (community/family)
5. Positive perception of daily chores and Parental stress
6. Beliefs about mental health stigma
7. Cognitive bandwidth of the caregivers
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
We designed the intervention as a cluster-randomized controlled trial in 125 village-level communities. In each village, we will enroll all caregiver-child dyads in which children are 6-24 months of age at the time of the survey. We will use a cluster-randomized design to reduce the risk of contamination by ensuring that all households in each cluster (i.e., in each community) are assigned to one of the three main intervention arms or the control arm:

- Treatment arm 1: Parenting Training (25 villages)
Parenting trainers (PTs) will deliver a parenting training curriculum to caregivers of children through weekly center or home visits. Weekly stage-based, age-appropriate sessions were developed targeting children from 6 up to 36 months of age. Each weekly session contains modules focusing on two out of four developmental modules: cognition, language, motor, and social-emotional skill development. Two PTs will be required to teach the parenting training curriculum.

- Treatment arm 2: Caregiver Mental Health Intervention (25 villages)
PTs will deliver the mental health curriculum to caregivers at the parenting centers on a bimonthly basis through group-based teaching and discussion sections. One PT will be required per center to teach the mental health curriculum.

- Treatment arm 3: Integrated Interventions (25 villages)
PTs will deliver both the parenting training curriculum on a weekly basis and the caregiver mental health intervention on a bimonthly basis to caregivers of the children. Three PTs in total (two for the parenting training programming and one for the mental health programming) will be required for the integrated parenting training and mental health curricula.

- Control arm: No intervention (50 villages)
These curricula will not be delivered to families in these villages. This arm serves as the no-intervention “control” arm in the study.

The intervention is designed to last for a period of one year.
Experimental Design Details
Not available
Randomization Method
Randomization done in office by a computer
Randomization Unit
Village
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
125 villages
Sample size: planned number of observations
1250 caregiver-child dyads from 125 villages (approximately 10 dyads per village)
Sample size (or number of clusters) by treatment arms
50 villages control, 25 villages parenting training intervention, 25 villages mental health support intervention, and 25 villages both interventions
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Power was estimated based on the treatment effects of parenting interventions documented in the literature (Andrew et al. 2020; Hamadani et al. 2019; Emmers et al. 2021) between study arms for the three primary outcome indicators: 1) overall child development, 2) active parenting practices, and 3) depressive symptom scores. Our sample size estimates account for randomization at the cluster level at .05 significance level. Overall child development. The power of the design was calculated given a 0.26 standard deviation effect (Emmers et al. 2021), assuming an intra-cluster correlation of .01 and a cluster size of 10 babies per village. Active Parenting Practices. The power of the design was calculated given a 0.39 standard deviation effect (Emmers et al. 2021), assuming an intra-cluster correlation of 0.01, and a cluster size of 10 babies per village. Depressive Symptom Score. The power of the design was calculated given a 0.27 standard deviation effect (Andrew et al. 2020; Hamadani et al. 2019), assuming an intra-cluster correlation of .01 and a cluster size of 10 babies per village. Based on these reference effect sizes, our study design holds powers of 0.88, 0.99, 0.90 when overall child development, active practices, and depressive symptom score serve as the outcome variable, respectively. To detect the difference in treatment effect between treatment arms, he minimal detectable effect needs to be 0.267 standard deviation (power = 0.8). 
IRB

Institutional Review Boards (IRBs)

IRB Name
Stanford University Institutional Review Board
IRB Approval Date
2022-08-10
IRB Approval Number
63680
Analysis Plan

Analysis Plan Documents

Pre-analysis Plan 06202024

MD5:

SHA1:

Uploaded At: June 21, 2024