NCT04749888

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. Furthermore, this study will utilize administrative data available for all study participants to evaluate both short and long-term impacts of the KECHI intervention on maternal and child outcomes.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
239mo left

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Oct 2021Dec 2045

First Submitted

Initial submission to the registry

November 5, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

October 27, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
20.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2045

Expected
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

3.4 years

First QC Date

November 5, 2020

Last Update Submit

July 11, 2025

Conditions

Child DevelopmentParentingInfant DevelopmentPregnancy RelatedMaternal Distress

Keywords

Home visitingChild health and developmentMaternal healthRandomized controlled trialCommunity intervention trialNurse home visitingRepublic of KoreaPrenatal and early childhood periods

Outcome Measures

Primary Outcomes (32)

  • Home environment

    Home environment as assessed using IT-HOME (Infant-Toddler Home Observation for Measurement of Environment) when the child is 6 months old. IT-HOME (Infant-Toddler Home Observation for Measurement of Environment), composed of 45 items, was developed by Caldwell \& Bradley (1984). The minimum score is 0 and the maximum score is 45, and a higher score means a better outcome.

    when the child is 6 months old.

  • Home environment

    Home environment as assessed using IT-HOME (Infant-Toddler Home Observation for Measurement of Environment) when the child is 12 months old. IT-HOME (Infant-Toddler Home Observation for Measurement of Environment), composed of 45 items, was developed by Caldwell \& Bradley (1984). The minimum score is 0 and the maximum score is 45, and a higher score means a better outcome.

    when the child is 12 months old.

  • Home environment

    Home environment as assessed using IT-HOME (Infant-Toddler Home Observation for Measurement of Environment) when the child is 24 months old. IT-HOME (Infant-Toddler Home Observation for Measurement of Environment), composed of 45 items, was developed by Caldwell \& Bradley (1984). The minimum score is 0 and the maximum score is 45, and a higher score means a better outcome.

    when the child is 24 months old.

  • Emergency department visits due to injuries

    Number of emergency department visits due to injuries when the child is 6 weeks old.

    when the child is 6 weeks old.

  • Emergency department visits due to injuries

    Number of emergency department visits due to injuries when the child is 6 months old.

    when the child is 6 months old.

  • Emergency department visits due to injuries

    Number of emergency department visits due to injuries when the child is 12 months old.

    when the child is 12 months old.

  • Emergency department visits due to injuries

    Number of emergency department visits due to injuries when the child is 24 months old.

    when the child is 24 months old.

  • Child development (K-Bayley-III)

    Child development as assessed using the K-Bayley-III (Korean Bayley Scales of Infant and Toddler Development-III) score when the child is 24 months old

    when the child is 24 months old.

  • Breastfeeding duration

    Breastfeeding duration when the child is 6 weeks old.

    when the child is 6 weeks old.

  • Breastfeeding duration

    Breastfeeding duration when the child is 6 months old.

    when the child is 6 months old.

  • Breastfeeding duration

    Maternal self-rated health when the child is 12 months old.

    when the child is 12 months old.

  • Breastfeeding duration

    Breastfeeding duration when the child is 24 months old.

    when the child is 24 months old.

  • Maternal self-rated health

    Maternal self-rated health when the child is 6 weeks old.

    when the child is 6 weeks old.

  • Maternal self-rated health

    Maternal self-rated health when the child is 6 months old.

    when the child is 6 months old.

  • Maternal self-rated health

    Maternal self-rated health when the child is 12 months old.

    when the child is 12 months old.

  • Maternal self-rated health

    Maternal self-rated health when the child is 18 months old.

    when the child is 18 months old.

  • Maternal self-rated health

    Maternal self-rated health when the child is 24 months old.

    when the child is 24 months old.

  • Community service linkage

    Community service linkage as measured by the number of community services a mother has received during the last year when the child is 12 months old.

    when the child is 12 months old.

  • Community service linkage

    Community service linkage as measured by the number of community services a mother has received during the last year when the child is 24 months old.

    when the child is 24 months old.

  • School readiness (EDI)

    School readiness as assessed using the Korean Early Development Instrument (EDI) administered by the child's teacher. The EDI evaluates children's overall developmental readiness for school across five domains: (1) Physical Health and Well-being, (2) Social Competence, (3) Emotional Maturity, (4) Language and Cognitive Development, and (5) Communication Skills and General Knowledge. The assessment consists of approximately 100 items based on teacher observations and takes 15-20 minutes per child to complete.

    when the child is 66 months old

  • Child Intelligence (WPPSI)

    Child intelligence assessed using the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV) administered by trained occupational therapist. The assessment measures overall intellectual ability and cognitive development.

    when the child is 66 months old

  • Child abuse

    Number of child abuse reports obtained through secondary data linkage with the Social Security Information Service's child abuse reporting database.

    when the child is 66 months old

  • Emergency department visits due to injuries (administrative data)

    Number of emergency department visits due to injuries (indirect indicator of child abuse) obtained via linkage with Korea National Health Insurance Service (NHIS) claims data.

    when the child is 66 months old

  • Maternal depression (PHQ-9)

    Maternal depression as assessed using the PHQ-9 (Patient Health Questionnaire-9) when the child is 42 months old. The PHQ-9 (Patient Health Questionnaire-9) was developed by Kroenke, K. et al. (2001) as a tool measuring the depression level of adults and composed of 9 items. The minimum score is 0 and the maximum score is 27, and higher score means a worse outcome.

    when the child is 42 months old

  • Maternal depression (PHQ-9)

    Maternal depression as assessed using the PHQ-9 (Patient Health Questionnaire-9) when the child is 54 months old. The PHQ-9 (Patient Health Questionnaire-9) was developed by Kroenke, K. et al. (2001) as a tool measuring the depression level of adults and composed of 9 items. The minimum score is 0 and the maximum score is 27, and higher score means a worse outcome.

    when the child is 54 months old

  • Maternal depression (PHQ-9)

    Maternal depression as assessed using the PHQ-9 (Patient Health Questionnaire-9) when the child is 66 months old. The PHQ-9 (Patient Health Questionnaire-9) was developed by Kroenke, K. et al. (2001) as a tool measuring the depression level of adults and composed of 9 items. The minimum score is 0 and the maximum score is 27, and higher score means a worse outcome.

    when the child is 66 months old

  • Maternal parenting behavior

    Maternal parenting behavior as assessed using a 17-item questionnaire measuring two dimensions: warm/responsive parenting and controlling parenting when the child is 42 months old. The warm/responsive dimension includes 9 items adapted by the Korea Institute of Child Care and Education from the Parental Style Questionnaire (Bornstein et al., 1996). The controlling dimension includes 8 items adapted by the Korea Institute of Child Care and Education based on Cho et al. (1999). Responses are rated on a 5-point Likert scale, with higher scores indicating greater endorsement of each parenting style.

    when the child is 42 months old

  • Maternal parenting behavior

    Maternal parenting behavior as assessed using a 17-item questionnaire measuring two dimensions: warm/responsive parenting and controlling parenting when the child is 54 months old. The warm/responsive dimension includes 9 items adapted by the Korea Institute of Child Care and Education from the Parental Style Questionnaire (Bornstein et al., 1996). The controlling dimension includes 8 items adapted by the Korea Institute of Child Care and Education based on Cho et al. (1999). Responses are rated on a 5-point Likert scale, with higher scores indicating greater endorsement of each parenting style.

    when the child is 54 months old

  • Maternal parenting behavior (32-PSDQ)

    Maternal parenting behavior as assessed using the 32-item Parenting Style and Dimensions Questionnaire (32-PSDQ), measuring authoritative, authoritarian, and permissive parenting styles, adapted from Robinson et al. (2001) and used in the Korean Early Childhood Education and Care Panel Study.

    when the child is 66 months old

  • Cognitive-stimulating home environment (Parent-child interaction)

    Cognitive-stimulating home environment as assessed using the Home Environment Activities and Cognitive Stimulation (HEQ) questionnaire adapted from the Early Childhood Longitudinal Study Kindergarten Cohort (ECLS-K) when the child is 42 months old. The Korean version was translated by the Korea Institute of Child Care and Education. The instrument consists of 10 items measuring frequency of cognitive stimulation activities between parents and children over the past week, rated on a 4-point scale.

    when the child is 42 months old

  • Cognitive-stimulating home environment (Parent-child interaction)

    Cognitive-stimulating home environment as assessed using the Home Environment Activities and Cognitive Stimulation (HEQ) questionnaire adapted from the Early Childhood Longitudinal Study Kindergarten Cohort (ECLS-K) when the child is 54 months old. The Korean version was translated by the Korea Institute of Child Care and Education. The instrument consists of 10 items measuring frequency of cognitive stimulation activities between parents and children over the past week, rated on a 4-point scale.

    when the child is 54 months old

  • Cognitive-stimulating home environment (Parent-child interaction)

    Cognitive-stimulating home environment as assessed using the Home Environment Activities and Cognitive Stimulation (HEQ) questionnaire adapted from the Early Childhood Longitudinal Study Kindergarten Cohort (ECLS-K) when the child is 66 months old. The Korean version was translated by the Korea Institute of Child Care and Education. The instrument consists of 10 items measuring frequency of cognitive stimulation activities between parents and children over the past week, rated on a 4-point scale.

    when the child is 66 months old

Secondary Outcomes (140)

  • Safety knowledge

    when the child is 6 months old.

  • Safety knowledge

    when the child is 12 months old.

  • Safety knowledge

    when the child is 24 months old.

  • Emergency department visits

    when the child is 6 weeks old.

  • Emergency department visits

    when the child is 6 months old.

  • +135 more secondary outcomes

Study Arms (2)

Targeted nurse-led home visiting

EXPERIMENTAL

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, strengths, and capacity using parenting education materials.

Behavioral: Targeted nurse-led home visiting

Control group

NO INTERVENTION

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

Interventions

Targeted nurse-led home visitingBEHAVIORAL

The 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. 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.

Also known as: KECHI (Korea Early Childhood Home-visiting Intervention)
Targeted nurse-led home visiting

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Health Policy and Management, Medical Research Center, Seoul National University

Seoul, 03080, South Korea

Location

Medical Research Collaborating Center, Seoul National University Biomedical Research Institute

Seoul, 03080, South Korea

Location

Related Publications (4)

  • Khang YH, Kim YM, Kim JH, Yu J, Oh R, June KJ, Cho SH, Lee JY, Cho HJ. Impact of the Korea Early Childhood Home-visiting Intervention (KECHI) on child health and development and maternal health: a randomised controlled trial protocol. BMJ Open. 2024 Aug 8;14(8):e082434. doi: 10.1136/bmjopen-2023-082434.

    PMID: 39122404BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

Study Officials

  • Young-Ho Khang, MD, PhD

    Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The research management staff, home visit nurses (intervention teams), and study participants will be aware of the allocation results. However, the research nurses making outcome assessments will be blinded to the randomization, and families will be asked not to disclose their group status during the surveys. The research nurses (outcome assessors) will only be notified of the survey schedules (6 weeks, 6 months, 12 months, and 24 months) of both groups so that the outcome indicators can be measured with blinding maintained. Statistical analysts will not be able to access the randomization variable until all 2 years of data are collected.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 5, 2020

First Posted

February 11, 2021

Study Start

October 27, 2021

Primary Completion

March 15, 2025

Study Completion (Estimated)

December 31, 2045

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)