Maternal and early childhood home visits have been proposed as an effective strategy to improve the health and development of disadvantaged children. In South Korea (hereafter, Korea), a maternal and early childhood home visit program has been implemented since 2013 in Seoul, and then was adopted in 2019 by the central government as a national policy for child health and development.
The Korea Early Childhood Home-visiting Intervention (KECHI) encompasses 25-29 home visits, group activities, and community service linkage by social workers from the prenatal period until the child reaches the age of 2 years; as such, it is a complex intervention involving various domains to address a wide range of outcomes. Each home visit is implemented based on the family's needs, and individualized interventions are provided to improve parenting and the home environment in order to promote children's health and development and maternal health.
This study is a randomized controlled community trial conducted in Korea to examine the impact of targeted home visits led by nurses in the prenatal and early childhood period on children's health and development and maternal health.
This study is a superiority trial with two parallel groups from pregnancy until the child reaches 2 years of age. Pregnant women with two or more risk factors will be recruited to participate in the study after they provide informed consent. Participants will then be randomly assigned to the intervention or control group with a 1:1 allocation through an independent web-based random allocation system. We expect a total of 800 families (400 families in each group) to be recruited. The intervention group will receive the KECHI program and the control group will receive existing maternal and child health services (usual care), but not multiple home visits by nurses. Both groups will receive gift cards of 30,000 Korean won (about 27 USD) for each round of surveys.
The intervention and control groups will be surveyed on the outcome variables of home environment, child development, breastfeeding, maternal health, child hospital visits due to injuries, and community service linkage at four home visits by trained research nurses at baseline and at 6 months, 12 months, and 24 months after birth. Telephone contact will also be made at 6 weeks and 18 months after birth for both groups. Outcome measurements will be performed by research nurses and data management will be conducted by statistical analysts. The analysis will be conducted for the intention-to-treat (ITT) and per-protocol (PP) groups, with an interim analysis of outcomes up to the 6-month follow-up. For the primary outcomes and certain secondary outcomes, subgroup analyses will be performed based on factors such as region, fertility status, number of risk factors, presence of depression, education level, etc.

Prevention

The KECHI encompasses 25-29 home visits, group activities, and community service linkage by social workers from the prenatal period until the child reach the age of 2 years; as such, it is a complex intervention involving various domains to address a wide range of outcomes. Pregnant women with two or more risk factors who are deemed to have difficulties in raising children are eligible for the targeted multiple nurse home visits. Each home visit is implemented based on families’ needs, and individualized interventions are provided to improve parenting and the home environment in order to promote the child’s health and development and maternal health. The program includes educational materials for parents, such as a booklet covering issues on prenatal care, child development, postnatal child care, parent-child attachment, play, communication, safety, and goal-setting. 
The content of each home visit is individually tailored to the mother's needs, skills, strength, and capacity. The services involve a partnership between the nurse and the family to maintain continuity of care, improve parenting competencies, and focus on the goals that families prioritize. For needy families, social workers may conduct home visits for community service linkage and brief interventions on maternal mental health. In addition, a five-session group activity for some families may be provided. The nurses and social workers are based at primary healthcare services in the local community (public health centers) and are trained on home visitation practices, as well as maternal and child health. They also receive additional training based on the family partnership model.

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The intervention group will receive 25-29 home visits during pregnancy and the first 2 years of life conducted by child health nurses. The frequency of home visits will be determined by nurses based on the needs of the families. The content of each home visit is individually tailored to the mother's needs, skills, strength, and capacity using parenting education materials. The services involve a partnership between the nurse and family to maintain continuity of care, improve parenting competencies, and focus on the goals that families prioritize. For needy families, social workers may provide home visits for community service linkage and brief interventions on maternal mental health. In addition, a five-session group activity for some families in the intervention group may be provided. The nurses and social workers are based at primary healthcare services in the local community (public health centers) and are trained on universal, regular home visitation practices, as well as maternal and child health. They also receive additional training based on the family partnership model.

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The control group will receive existing maternal and child health services (usual care) except for the nurse-led intensive home visits.

Gender

Age

Description

① Pregnant women with two or more risk factors at the time of screening 
② Pregnant women at less than 37 weeks of gestation
③ Pregnant women who can read and answer questionnaires in Korean
④ Pregnant women living in districts where the KECHI service is available

① Pregnant women who have experienced any critical event such as termination of pregnancy, stillbirth, or child death
② Pregnant women who plan to move abroad or to other regions where KECHI is not available within the next 6 months.

Infant/Toddler Home Observation for Measurement of the Environment

6 month, 12 month, and 24 month follow-up after birth

K-Bayley-III (Korean Bayley Scales of Infant and Toddler Development-III)

24 month follow-up after birth

Emergency department visits due to injuries

6 week, 6 month, 12 month, and 24 month follow-up after birth

Breastfeeding duration

6 week, 6 month, 12 month, and 24 month follow-up after birth

Maternal self-rated health

6 week, 6 month, 12 month, 18 month, and 24 month follow-up after birth

Community service linkage

12 month, and 24 month follow-up after birth

Safety knowledge

6 month, 12 month, and 24 month follow-up after birth

Denver developmental screening test

6 month, 12 month, and 24 month follow-up after birth

Premature birth

6 week after birth

Delayed growth

6 month, 12 month, and 24 month follow-up after birth

Knowledge of sudden infant death syndrome prevention 

6 month follow-up after birth

Vaccination

6 month, 12 month, and 24 month follow-up after birth

National health check-ups

6 month, 12 month, and 24 month follow-up after birth

Spousal participation in parenting

6 month, 12 month, and 24 month follow-up after birth

Parenting related household expenses

6 month, 12 month, and 24 month follow-up after birth

Maternal depression (Edinburgh Depression Scale and Patient Health Questionnaire-9 items)

6 month, 12 month, and 24 month follow-up after birth

Maternal anxiety (General Anxiety Scale-2 items)

6 month, 12 month, and 24 month follow-up after birth

Maternal tobacco use

6 month, 12 month, and 24 month follow-up after birth

Maternal alcohol use

6 month, 12 month, and 24 month follow-up after birth

Delivery type

6 week follow-up after birth

Maternal parenting stress (Being a Mother Scale-13 items)

6 month, 12 month, and 24 month follow-up after birth

Intimate partner violence (Hurt, Insult, Threaten, and Scream-4 items)

6 month, 12 month, and 24 month follow-up after birth

Maternal body weight

6 week, 6 month, 12 month, and 24 month follow-up after birth

Social support questionnaires (12 items)

6 month, 12 month, and 24 month follow-up after birth

Food insecurity

12 month, and 24 month follow-up after birth

Spouse intimacy (Revised-Kansas Marital Satisfaction Scale-4 items)

6 month, 12 month, and 24 month follow-up after birth

Spousal tobacco use

6 month, 12 month, and 24 month follow-up after birth

Spousal alcohol consumption

6 month, 12 month, and 24 month follow-up after birth

Parent-child interaction (NCAST (Nursing Child Assessment Satellite training)-PCI (Parent-Child Interaction) teaching scale (73 items))

12 month and 24 month follow-up after birth

Emergency department visits

6 week, 6 month, 12 month and 24 month follow-up after birth

Hospital admission

6 week, 6 month, 12 month and 24 month follow-up after birth

Maternal depression (Patient Health Questionnaire-9)

6 month, 12 month, and 24 month follow-up after birth

Maternal depression (Whooley & Arroll questions-3 items)

6 week and 18 month follow-up after birth

Intention to have another child

24 month follow-up after birth

Experience of delivery in the past 2 years

24 month follow-up after birth