Impact of the Korea Early Childhood Home-visiting Intervention

Condition(s) studied

Investigational drug(s) / intervention(s)

Targeted nurse-led home visiting: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Home environment — when the child is 6 months old.
  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.
• Home environment — when the child is 12 months old.
  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.
• Home environment — when the child is 24 months old.
  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.
• Emergency department visits due to injuries — when the child is 6 weeks old.
  Number of emergency department visits due to injuries when the child is 6 weeks old.
• Emergency department visits due to injuries — when the child is 6 months old.
  Number of emergency department visits due to injuries when the child is 6 months old.
• Emergency department visits due to injuries — when the child is 12 months old.
  Number of emergency department visits due to injuries when the child is 12 months old.
• Emergency department visits due to injuries — when the child is 24 months old.
  Number of emergency department visits due to injuries when the child is 24 months old.
• Child development (K-Bayley-III) — when the child is 24 months old.
  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
• Breastfeeding duration — when the child is 6 weeks old.
  Breastfeeding duration when the child is 6 weeks old.
• Breastfeeding duration — when the child is 6 months old.
  Breastfeeding duration when the child is 6 months old.
• Breastfeeding duration — when the child is 12 months old.
  Maternal self-rated health when the child is 12 months old.
• Breastfeeding duration — when the child is 24 months old.
  Breastfeeding duration when the child is 24 months old.
• Maternal self-rated health — when the child is 6 weeks old.
  Maternal self-rated health when the child is 6 weeks old.
• Maternal self-rated health — when the child is 6 months old.
  Maternal self-rated health when the child is 6 months old.
• Maternal self-rated health — when the child is 12 months old.
  Maternal self-rated health when the child is 12 months old.
• Maternal self-rated health — when the child is 18 months old.
  Maternal self-rated health when the child is 18 months old.
• Maternal self-rated health — when the child is 24 months old.
  Maternal self-rated health when the child is 24 months old.
• Community service linkage — when the child is 12 months old.
  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.
• Community service linkage — when the child is 24 months old.
  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.
• School readiness (EDI) — when the child is 66 months old
  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.
• Child Intelligence (WPPSI) — when the child is 66 months old
  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.
• Child abuse — when the child is 66 months old
  Number of child abuse reports obtained through secondary data linkage with the Social Security Information Service's child abuse reporting database.
• Emergency department visits due to injuries (administrative data) — when the child is 66 months old
  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.
• Maternal depression (PHQ-9) — when the child is 42 months old
  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.
• Maternal depression (PHQ-9) — when the child is 54 months old
  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.
• Maternal depression (PHQ-9) — when the child is 66 months old
  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.
• Maternal parenting behavior — when the child is 42 months old
  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.
• Maternal parenting behavior — when the child is 54 months old
  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.
• Maternal parenting behavior (32-PSDQ) — when the child is 66 months old
  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.
• Cognitive-stimulating home environment (Parent-child interaction) — when the child is 42 months old
  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.
• Cognitive-stimulating home environment (Parent-child interaction) — when the child is 54 months old
  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.
• Cognitive-stimulating home environment (Parent-child interaction) — when the child is 66 months old
  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.

Trial sites (2)

More Seoul National University Hospital trials in South Korea