Condition category
Not Applicable
Date applied
12/09/2018
Date assigned
23/10/2018
Last edited
23/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Studies have shown that children growing up in poor, rural Chinese regions during the first years of life are at high risk of developmental delays. Given that approximately half of all Chinese infants in China are currently growing up in rural regions, a large share of all Chinese children are currently at risk of missing out on their full developmental potential.
These early delays have been linked to poor parenting practices. First, studies found that the average engagement of caregivers in interactive caregiver-child activities in rural China was low. For example, only 11 percent of parents reported that they told a story to the child on the day before. Second, common problematic feeding practices, such as feeding the child a diet with a low nutrient density, have also been linked to poor child development. Third, early development may be hampered by lacking health promoting behaviours of caregivers, for instance, late initiation of toothbrushing.
Earlier intervention studies in rural China have convincingly shown that parenting training programs focusing on caregiver-child interaction can effectively reduce the emergence of early cognitive delays. This study aims to assess whether a parenting program combining training on child psychosocial stimulation with information on child nutrition and health promotion can adjust problematic parenting skills and practices and improve early child development, health, nutrition, and physical growth outcomes.

Who can participate?
All 6-18 month olds that are living in the selected villages in rural Hebei Province and Yunnan Province, China at the start of the study, with their main caregivers

What does the study involve?
Participating villages are randomly assigned to intervention and control. All 6-18 month olds and their main caregivers living in villages assigned to intervention are selected to participate in a parenting program. Those in the control group will receive no intervention. Caregivers and children in the intervention group were invited to participate in biweekly parenting training sessions delivered at home by a community health worker. Caregivers are taught how to interact with their children in ways that can improve their cognition, language, motor, and social-emotional development. Caregivers also receive information on feeding practices (e.g. breastfeeding) and health promoting parenting practices (e.g. tooth brushing). Data collected for the study include measures of child development, health, nutrition, and growth, as well as measures of caregivers' knowledge on and behaviour towards best parenting and feeding practices. The study takes place over 31 months.

What are the possible benefits and risks of participating?
This study is expected to benefit children whose main caregivers participate in the intervention study. Child early development, health, nutrition, and physical growth status may improve in response to more stimulating home learning environments, better feeding practices and health promotion. It is also hoped that caregivers may apply taught parenting skills and practices to improve developmental outcomes of other children living in the household and neighbourhood. Moreover, this curriculum may be scalable if proven successful.
There are no known risks to participants taking part in this study.

Where is the study run from?
Centre for Chinese Agricultural Policy (CCAP), Chinese Academy of Sciences (CAS) (China)

When is the study starting and how long is it expected to run for?
June 2015 to December 2017

Who is funding the study?
Save the Children Hong Kong (China)

Who is the main contact?
Prof. Dr. Renfu Luo
luorf.ccap@igsnrr.ac.cn

Trial website

Contact information

Type

Public

Primary contact

Prof Renfu Luo

ORCID ID

Contact details

No. Jia 11 Datun Road
Anwai
Beijing
100101
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PerfectingParenting-YH01

Study information

Scientific title

Using community health workers to deliver an integrated parenting program in rural China: A cluster-randomized controlled trial

Acronym

Study hypothesis

We hypothesize that participation in our parenting intervention will lead to significant improvements in parenting knowledge, skills, and practices as well as child development, health, and nutrition outcomes.

Ethics approval

Stanford University Institutional Review Board Protocol, 26/10/2012, reference number 25734

Study design

Interventional single-centre non-masked cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Home

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Parenting attitudes, knowledge, and practice
Early child development, child health, child nutrition and physical growth

Intervention

All of the communities (villages) in the sample were randomly assigned to intervention and control using a computerized random number generator.
Families assigned to the control group receive no intervention.
Families in the intervention group are invited to participate in biweekly parenting training sessions delivered at home over a period of two years. During each home visit, community health workers introduce 2 age-appropriate, interactive caregiver-child activities targeting development in four developmental domains: cognition, language, motor, and social-emotional development. Each activity is fully-scripted in an ECD curriculum that is loosely based on the "Jamaica curriculum" developed by Sally Grantham-McGregor and further developed by local child development psychologists and ECD experts. The curriculum previously underwent field testing and evaluation in rural China by our government partners at the National Health and Family Planning Commission (NHFPC) and our evaluation team. In addition to parenting training on interactive activities, caregivers receive stage-based information on child health and nutrition during each home visit. Community health workers provide information on child nutrition and health promotion based on fully-scripted, structured conversations developed by experts of the Capital Institute of Pediatrics (CIP) of the Chinese Academy of Medical Sciences (CAMS).
No further follow-up treatment is planned.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

The following will be assessed at the baseline and during three rounds of follow-up at the end of each intervention year:
1. Children's cognitive, language, motor, and social-emotional development, assessed using:
1.1. Cognition, language, motor and social-emotional scales of the third edition of the Bayley Scales of Infant and Toddler Development (Bayley-III)
1.2. Scales for communication, gross motor, fine motor, personal-social, problem solving, and overall development of the third edition of the Ages & Stages Questionnaire (ASQ-3)
1.3. The Ages & Stages Questionnaire: Social-Emotional (ASQ:SE)
2. Child health status, assessed using carer-reported health measures included in the household questionnaire
3. Child micronutrient status, assessed using haemoglobin values measured with fingerprick blood testing
4. Child weight, measured in kg using a scale
5. Child height, measured in cm using a recumbent baby length scale for 0-2 year olds and a child height scale for children over 2 years of age

Secondary outcome measures

The following are assessed prior to treatment assignment (baseline) and during two rounds of follow-up at the end of each intervention year:
1. Caregivers' attitudes, knowledge, and behaviour with regard to early child psychosocial stimulation, health promotion, hygiene, and feeding practices, assessed using a comprehensive household questionnaire administered to the primary caregiver of the child,
2. Quality of the home learning environment, assessed using the Family Care Indicators (FCI) survey
3. Caregivers' perceived social support and parental mental wellbeing, assessed using:
3.1. Parenting and Family Adjustment Scale (PAFAS)
3.2. Depression Anxiety and Stress Scale (DASS)
3.3. Office of National Statistics (ONS) subjective wellbeing survey

Overall trial start date

01/06/2015

Overall trial end date

31/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All babies aged 6-18 months at the start of the study (and their main caregivers) who live in the sample villages

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

We aimed to include at least 40 villages with an estimated 10 participating households per village. After allowing for attrition, we expected to enroll at least 400 households in the study, amounting to around 800 individuals (400 caregivers + 400 children).

Participant exclusion criteria

1. Rich urban areas
2. Children with severe anaemia after initial blood tests (these children were then referred to a doctor for treatment)

Recruitment start date

01/09/2015

Recruitment end date

01/11/2015

Locations

Countries of recruitment

China

Trial participating centre

Nortwest Socio-economic Development Research Center, School of Management, Northwest University
No. 229 North Taibai Avenue Northwest University
Xi'an
710068
China

Trial participating centre

Centre for Chinese Agricultural Policy (CCAP), Chinese Academy of Sciences
No. 11A, Datun Road, Anwai
Beijing
100101
China

Sponsor information

Organisation

Rural Education Action Program (REAP), Freeman Spogli Institute (FSI), Stanford University

Sponsor details

616 Serra Street
Encina Hall E501
Stanford
94305
United States of America

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

Save the Children Hong Kong

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal one year after the end of the trial.

IPD sharing statement:
The dataset generated during and analysed during the current study will be available upon request from Professor Luo Renfo, luorf.ccap@igsnrr.ac.cn. 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 was 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.

Intention to publish date

31/12/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes