The “Digital Plus” approach to upscaling early childhood development services: evaluating the effectiveness of a mixed online-offline caregiver education program in rural China
| ISRCTN | ISRCTN15854033 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15854033 |
| Secondary identifying numbers | CFRD2024 |
- Submission date
- 28/06/2024
- Registration date
- 13/02/2025
- Last edited
- 13/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Rates of developmental delay remain high among young children in many low- and middle-income countries. One effective way to promote early childhood development in these settings is through programs during which trainers visit caregivers in the home and teach them activities and skills to stimulate their child’s development. However, such programs have typically been costly and difficult to expand across wide areas or large populations. This study, conducted in rural China, seeks to determine if delivering the training partially through a specially designed digital app can increase the scalability of a parenting training program without compromising its effectiveness.
Who can participate?
Caregivers and children (6-24 months) living in the sample villages at the time of the survey.
What does the study involve?
The study will be undertaken in 80 villages in three rural counties in a province in central China. Caregivers in 40 villages will receive training for one year, with the first two months of training occurring in person, and the next ten months occurring over the app (with in-person visits every two months to check in). Caregivers in the other 40 villages will not receive any training and will serve as the control group. The primary outcome will be early childhood development. Secondary outcomes will include caregiver mental health, caregivers’ usage and attitudes toward digital programs, caregivers’ attitudes and feelings about parenting, and the amount of time and resources that caregivers put into stimulating their child’s development.
What are the possible benefits and risks of participating?
This research will generate rigorous evidence on the impact of government-administered ECD programs on child psychosocial stimulation. The potential benefits of this study are improved cognitive and non-cognitive skills of children. If successful, the intervention will also offer broader insights that can inform future programs and policies to promote early childhood development at scale in rural China. There are no possible risks of participation.
Where is the study run from?
1. Stanford University (United States of America)
2. Southwestern University of Finance and Economics (China)
3. Zhongnan University of Economics and Law (China)
When is the study starting and how long is it expected to run for?
July 2023 to October 2025
Who is funding the study?
1. Xinhe Foundation (China)
2. Private donations
3. Give2Asia
Who is the main contact?
Kelly Reiling, kreiling@stanford.edu
Contact information
Scientific, Principal Investigator
Research Institute of Economics and Management
Southwestern University of Finance and Economics
Chengdu
610074
China
| Phone | +86 18123223929 |
|---|---|
| qianyw@swufe.edu.cn |
Scientific, Principal Investigator
Zhongnan University of Economics and Law
Wuhan
430000
China
| Phone | +8615209295373 |
|---|---|
| lishanceee@163.com |
Public
Stanford University
616 Jane Stanford Way
Stanford
94305
United States of America
| Phone | +1-650-723-4581 |
|---|---|
| kreiling@stanford.edu |
Study information
| Study design | Cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Internet/virtual |
| Study type | Quality of life |
| Scientific title | Evaluating the effectiveness and sustainability of mixed online-offline deployment in providing early childhood development services at scale in rural China |
| Study acronym | Digital Plus for ECD |
| Study objectives | Past research has established that home visit-based parent education programs promote cognitively stimulating parenting practices and early child development in households with children under the age of 2 years. The study objective is to determine whether mixed offline and online delivery of parenting training can maintain intervention effectiveness while reducing costs and increasing scalability. While parenting training will be conducted via in-person home visits during the first two months of the intervention, most training beyond this point will occur via prerecorded video through a specially designed app, reducing the number of trainers needed to deliver the training throughout the study period. On the village level, the intervention will be implemented by two types of municipal government-affiliated authorities overseeing women’s and family issues in rural areas of China, peer mothers (tongban mama) and children’s committee directors (ertong zhuren). Moreover, local doctors will be asked to send reminder texts to caregivers in the treatment group to remind them to engage with online training materials. By reducing the number of staff needed overall to conduct training and entrusting most village-level implementation to local authorities in the municipal and medical systems, the project design has the potential to be significantly upscaled or expanded to remote areas with relatively low additional cost. Various steps will be taken to offset the potential negative impacts of offline delivery on the training’s effectiveness in promoting ECD, including conducting additional in-home visits every two months during the primarily online delivery period. Therefore, it is hypothesized that this mixed online-offline study design will produce significantly positive effects on ECD outcomes comparable to those found in past, fully offline parenting training interventions. |
| Ethics approval(s) |
Approved 27/03/2024, China Center for Behavioral Economics and Finance Research Ethics Committee (555, Liutai Avenue, Wenjiang District, Chengdu, 611130, China; +86 (028) 87098046; ccbef@swufe.edu.cn), ref: n/a |
| Health condition(s) or problem(s) studied | Improvement in early childhood psychosocial development among rural children in China |
| Intervention | The Digital Plus project seeks to develop, deliver, and evaluate a multi-stage, mixed-format caregiver education program to target early childhood psychosocial development in rural China. The intervention contains two arms, one that receives the early childhood development education services (treatment) and one that does not (control), and will occur in two phases. The first phase is fully offline and will last two months. During this phase, caregivers in the treatment group will receive weekly in-home, in-person lessons from parenting trainers recruited for this project. The content of the lessons mostly consists of an activity-based parenting training curriculum that is based on the preexisting Reach Up and Learn curriculum and was adapted by the research team with assistance from early childhood development experts in China. In the adapted curriculum, parenting trainers will conduct one session per week that guides caregivers through interactive activities that are designed to stimulate the early development of children between 6 and 36 months old across four dimensions: cognitive, language, motor, and social-emotional skill development. Trainers will also lend caregivers toys and books and instruct them to use these materials to practice that week’s activities before the next session. In addition to the activity-based curriculum, trainers will also deliver feedback about the caregiver’s interactions with the target child using a handbook developed by the research team in partnership with experts from China. The second phase contains mixed online and offline deployment and will last ten months. During this phase, caregivers will continue to receive activity-based lessons following the parenting curriculum, but the lessons will take the form of prerecorded videos delivered through an app developed for this project. Community health workers will continue to lend caregivers toys and books related to each week’s lesson and will be on hand to assist caregivers if they have questions. Once every two months, the parenting trainers will conduct another home visit to answer questions and offer feedback on the caregiver’s interaction skills using the handbook. |
| Intervention type | Behavioural |
| Primary outcome measure | Early childhood psychosocial development will be measured using the following scales at baseline and endline (i.e., after 1 year at the end of the trial): 1. Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) 2. Ages and Stages Questionnaires: Social-emotional (ASQ:SE) 3. New Wolke Social-Emotional Behavior Ratings |
| Secondary outcome measures | The following secondary outcome measures will be assessed at baseline and endline (i.e., after 1 year at the end of the trial): 1. Parenting and attachment style, measured with: 1.1. The World Value Survey 1.2 The Mother’s Object Relations Scale – Short Form (MORS-SF) 2. Parenting stress, measured with the Parenting Stress Index 3. Parental investments in stimulating parenting practices and materials, measured with: 3.1. The Family Care Indicators (FCI) 3.2. Home Observation Measurement of the Environment – Short Form (HOME-SF) 4. Parenting self-efficacy, measured with the TOol to measure Parenting Self-Efficacy (TOPSE) 5. Caregiver mental health, measured using: 5.1. The Patient Health Questionnaire (PHQ) 5.2. The Depression, Anxiety, and Stress Scales, 21 items (DASS-21) 6. Positive perception of daily chores, measured with the Parenting Daily Hassles Scale (PDH) 7. Structural and functional social support (community/family), measured with the Multidimensional Scale of Perceived Social Support (MSPSS) 8. Caregiver digital literacy, measured using a self-designed questionnaire 9. Caregiver and child screen exposure measured using data collected by devices |
| Overall study start date | 19/07/2023 |
| Completion date | 01/10/2025 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 1280 |
| Key inclusion criteria | 1. Caregivers of a child 6-24 months of age living in the village at the time of surveying 2. Children aged 6-24 months at the time of surveying 3. Willing to participate in the parenting center programs (parenting training and mental health) 4. Willing to participate in the impact evaluation, including the child surveys, caregiver surveys, and household surveys 5. Able and willing to give informed consent |
| Key exclusion criteria | 1. Children with a severe disability 2. Caregivers who are unwilling or unable to give informed consent 3. Caregivers who are unwilling to participate |
| Date of first enrolment | 01/08/2024 |
| Date of final enrolment | 01/09/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Wuhan
430000
China
Sponsor information
University/education
Encina Hall
616 Jane Stanford Way
Stanford University
Stanford
94305
United States of America
| Phone | 650-723-4581 |
|---|---|
| kreiling@stanford.edu | |
| Website | https://sccei.fsi.stanford.edu/ |
Funders
Funder type
Charity
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal one year after the end of the trial |
| IPD sharing plan | The dataset generated and analyzed during the current study will be available upon request from Professor Qian Yiwei (qyw.ray@gmail.com). De-identified data may be made available to researchers upon request and after careful reviewing of the research aim of the applying researcher. Oral consent will be obtained from the interviewees and trial participants before survey administration and treatment enrollment. All datasets will be de-identified by removal of names, household IDs and village IDs. |
Editorial Notes
28/06/2024: Study's existence confirmed by the China Center for Behavioral Economics and Finance Research Ethics Committee.
