Clinical trial NCT04749888: Impact of the Korea Early Childhood Home-visiting Intervention
Official title: Impact of the Korea Early Childhood Home-visiting Intervention on Childhood Health and Development and Maternal Health: A Randomized Controlled Community Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child Development
Parenting
Infant Development
Pregnancy Related
Maternal Distress
Keywords: Home visiting
Child health and development
Maternal health
Randomized controlled trial
Community intervention trial
Nurse home visiting
Republic of Korea
Prenatal and early childhood periods
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Evidence-Based Healthcare Collaborating Agency
name: Seoul National University
name: Hanyang University
name: Soon Chun Hyang University
name: Kangwon National University
name: University of Ulsan
First posted: 2021-02-11
Enrollment: 800
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Pregnant women with two or more risk factors at the time of screening
* Pregnant women at less than 37 weeks of gestation
* Pregnant women who can read and answer questionnaires in Korean

Exclusion Criteria:

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

Primary outcomes:
measure: Home environment
timeFrame: when the child is 6 months old.
measure: Home environment
timeFrame: when the child is 12 months old.
measure: Home environment
timeFrame: when the child is 24 months old.
measure: Emergency department visits due to injuries
timeFrame: when the child is 6 weeks old.
measure: Emergency department visits due to injuries
timeFrame: when the child is 6 months old.
measure: Emergency department visits due to injuries
timeFrame: when the child is 12 months old.
measure: Emergency department visits due to injuries
timeFrame: when the child is 24 months old.
measure: Child development (K-Bayley-III)
timeFrame: when the child is 24 months old.
measure: Breastfeeding duration
timeFrame: when the child is 6 weeks old.
measure: Breastfeeding duration
timeFrame: when the child is 6 months old.
measure: Breastfeeding duration
timeFrame: when the child is 12 months old.
measure: Breastfeeding duration
timeFrame: when the child is 24 months old.
measure: Maternal self-rated health
timeFrame: when the child is 6 weeks old.
measure: Maternal self-rated health
timeFrame: when the child is 6 months old.
measure: Maternal self-rated health
timeFrame: when the child is 12 months old.
measure: Maternal self-rated health
timeFrame: when the child is 18 months old.
measure: Maternal self-rated health
timeFrame: when the child is 24 months old.
measure: Community service linkage
timeFrame: when the child is 12 months old.
measure: Community service linkage
timeFrame: when the child is 24 months old.
Secondary outcomes:
measure: Safety knowledge
timeFrame: when the child is 6 months old.
measure: Safety knowledge
timeFrame: when the child is 12 months old.
measure: Safety knowledge
timeFrame: when the child is 24 months old.
measure: Emergency department visits
timeFrame: when the child is 6 weeks old.
measure: Emergency department visits
timeFrame: when the child is 6 months old.
measure: Emergency department visits
timeFrame: when the child is 12 months old.
measure: Emergency department visits
timeFrame: when the child is 24 months old.
measure: Hospital admission
timeFrame: when the child is 6 weeks old.
measure: Hospital admission
timeFrame: when the child is 6 months old.
measure: Hospital admission
timeFrame: when the child is 12 months old.
measure: Hospital admission
timeFrame: when the child is 24 months old.
measure: Child development (Denver II)
timeFrame: when the child is 6 months old.
measure: Child development (Denver II)
timeFrame: when the child is 12 months old.
measure: Child development (Denver II)
timeFrame: when the child is 24 months old.
measure: Premature birth
timeFrame: when the child is 6 weeks old.
measure: Delayed growth - height
timeFrame: when the child is 6 months old.
measure: Delayed growth - height
timeFrame: when the child is 12 months old.
measure: Delayed growth - height
timeFrame: when the child is 24 months old.
measure: Delayed growth - weight
timeFrame: when the child is 6 months old.
measure: Delayed growth - weight
timeFrame: when the child is 12 months old.
measure: Delayed growth - weight
timeFrame: when the child is 24 months old.
measure: Delayed growth - head circumference
timeFrame: when the child is 6 months old.
measure: Delayed growth - head circumference
timeFrame: when the child is 12 months old.
measure: Delayed growth - head circumference
timeFrame: when the child is 24 months old.
measure: Knowledge of SIDS (sudden infant death syndrome) prevention
timeFrame: when the child is 6 months old.
measure: Vaccination
timeFrame: when the child is 6 months old.
measure: Vaccination
timeFrame: when the child is 12 months old.
measure: Vaccination
timeFrame: when the child is 24 months old.
measure: National health check-ups
timeFrame: when the child is 6 months old.
measure: National health check-ups
timeFrame: when the child is 12 months old.
measure: National health check-ups
timeFrame: when the child is 24 months old.
measure: Spousal participation in parenting
timeFrame: when the child is 6 months old.
measure: Spousal participation in parenting
timeFrame: when the child is 12 months old.
measure: Spousal participation in parenting
timeFrame: when the child is 24 months old.
measure: Parenting related household expenses
timeFrame: when the child is 6 months old.
measure: Parenting related household expenses
timeFrame: when the child is 12 months old.
measure: Parenting related household expenses
timeFrame: when the child is 24 months old.
measure: Intention to have another child
timeFrame: when the child is 24 months old.
measure: Experience of delivery in the past 2 years
timeFrame: when the child is 24 months old.
measure: Depression (EPDS)
timeFrame: when the child is 6 months old.
measure: Depression (EPDS)
timeFrame: when the child is 12 months old.
measure: Depression (EPDS)
timeFrame: when the child is 24 months old.
measure: Suicidal ideation
timeFrame: when the child is 6 months old.
measure: Suicidal ideation
timeFrame: when the child is 12 months old.
measure: Suicidal ideation
timeFrame: when the child is 24 months old.
measure: Depression (PHQ-9)
timeFrame: when the child is 6 months old.
measure: Depression (PHQ-9)
timeFrame: when the child is 12 months old.
measure: Depression (PHQ-9)
timeFrame: when the child is 24 months old.
measure: Depression (Whooley & Arroll questions)
timeFrame: when the child is 6 weeks old.
measure: Depression (Whooley & Arroll questions)
timeFrame: when the child is 18 months old.
measure: Anxiety
timeFrame: when the child is 6 months old.
measure: Anxiety
timeFrame: when the child is 12 months old.
measure: Anxiety
timeFrame: when the child is 24 months old.
measure: Maternal tobacco use
timeFrame: when the child is 6 months old.
measure: Maternal tobacco use
timeFrame: when the child is 12 months old.
measure: Maternal tobacco use
timeFrame: when the child is 24 months old.
measure: Maternal alcohol consumption
timeFrame: when the child is 6 months old.
measure: Maternal alcohol consumption
timeFrame: when the child is 12 months old.
measure: Maternal alcohol consumption
timeFrame: when the child is 24 months old.
measure: Delivery type
timeFrame: when the child is 6 weeks old.
measure: Maternal parenting stress
timeFrame: when the child is 6 months old.
measure: Maternal parenting stress
timeFrame: when the child is 12 months old.
measure: Maternal parenting stress
timeFrame: when the child is 24 months old.
measure: Intimate partner violence
timeFrame: when the child is 6 months old.
measure: Intimate partner violence
timeFrame: when the child is 12 months old.
measure: Intimate partner violence
timeFrame: when the child is 24 months old.
measure: Maternal body weight
timeFrame: when the child is 6 weeks old.
measure: Maternal body weight
timeFrame: when the child is 6 months old.
measure: Maternal body weight
timeFrame: when the child is 12 months old.
measure: Maternal body weight
timeFrame: when the child is 24 months old.
measure: Social support
timeFrame: when the child is 6 months old.
measure: Social support
timeFrame: when the child is 12 months old.
measure: Social support
timeFrame: when the child is 24 months old.
measure: Food insecurity
timeFrame: when the child is 12 months old.
measure: Food insecurity
timeFrame: when the child is 24 months old.
measure: Spousal intimacy
timeFrame: when the child is 6 months old.
measure: Spousal intimacy
timeFrame: when the child is 12 months old.
measure: Spousal intimacy
timeFrame: when the child is 24 months old.
measure: Spousal tobacco use
timeFrame: when the child is 6 months old.
measure: Spousal tobacco use
timeFrame: when the child is 12 months old.
measure: Spousal tobacco use
timeFrame: when the child is 24 months old.
measure: Spousal alcohol consumption
timeFrame: when the child is 6 months old.
measure: Spousal alcohol consumption
timeFrame: when the child is 12 months old.
measure: Spousal alcohol consumption
timeFrame: when the child is 24 months old.
measure: Parent-child interaction
timeFrame: when the child is 12 months old.
measure: Parent-child interaction
timeFrame: when the child is 24 months old.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Institute of Health Policy and Management, Medical Research Center, Seoul National University
city: Seoul
country: Korea, Republic of
facility: Medical Research Collaborating Center, Seoul National University Biomedical Research Institute
Study officials:
affiliation: Seoul National University College of Medicine
name: Young-Ho Khang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: June KJ, Lee JY, Cho SH. Infant Mother's Experiences with the Sustained Nurse Home-Visiting Program. J Korean Soc Matern Child Health. 2021;25(1):31-41.
citation: Khang YH, Cho SH, June KJ, Lee JY, Kim YM, Cho HJ. The Seoul healthy first step project: Introduction and expansion, program content and performance, and future challenges. Journal of the Korean Society of Maternal and Child Health. 2018;22(2):63-76.
citation: Lee JY, June KJ, Cho S-H. Competencies of nurses in a maternal early childhood sustained home-visiting program. Journal of Korean Academy of Community Health Nursing. 2017;28(4):397-409.