Impact of the Korea Early Childhood Home-visiting Intervention

Study Overview
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Brief Summary
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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. In 2020, a new national home visit program where nurses (with social workers) make multiple home visits to vulnerable families starting prenatally and continuing until the child reaches the age of 2 years, was newly developed and launched throughout the country. 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. 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. 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 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 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 by research nurses and data management by statistical analysts will be performed with blinding regarding the random allocation.

Official Title
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Impact of the Korea Early Childhood Home-visiting Intervention on Childhood Health and Development and Maternal Health: A Randomized Controlled Community Trial

Conditions
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Child Development, Infant Development, Parenting, Pregnancy Related, Maternal Distress

Intervention / Treatment
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* Behavioral: Targeted nurse-led home visiting


Participation Criteria
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Eligibility Criteria
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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 Pregnant women living in districts where the KECHI service is available 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 2 years
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted nurse-led home visiting<br>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<br>* 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.<br>* Other names: KECHI (Korea Early Childhood Home-visiting Intervention);|
| No Intervention: Control group<br>The control group will receive existing maternal and child health services (usual care) except for the targeted nurse-led home visits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home environment for optimal child development and safety | Home environment for optimal child development and safety 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 for optimal child development and safety | Home environment for optimal child development and safety 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. | 
| Hospital visits due to injury | Number of hospital visits due to injury when the child is 24 months old. | when the child is 24 months old. | 
| Bayley scale | Bayley scale as assessed using the K-BSID-3 (Korean Bayley Scales of Infant Development-3) score when the child is 24 months old | when the child is 24 months old. | 
| Breastfeeding duration | Breastfeeding duration when the child is 6 months old. | when the child is 6 months old. | 
| Breastfeeding duration | Breastfeeding duration 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 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 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety knowledge | Safety knowledge as measured by the number of questions the mother answered correctly about child accident prevention when the child is 6 months old. The questionnaire testing mothers' safety knowledge is composed of five items from the Korean National Health Insurance Service's Infant Health Examination Questionnaire. | when the child is 6 months old. | 
| Safety knowledge | Safety knowledge as measured by the number of questions the mother answered correctly about child accident prevention when the child is 12 months old. The questionnaire testing mothers' safety knowledge is composed of five items from the Korean National Health Insurance Service's Infant Health Examination Questionnaire. | when the child is 12 months old. | 
| Safety knowledge | Safety knowledge as measured by the number of questions the mother answered correctly about child accident prevention when the child is 24 months old. The questionnaire testing mothers' safety knowledge is composed of five items from the Korean National Health Insurance Service's Infant Health Examination Questionnaire. | when the child is 24 months old. | 
| Child development | Child development as assessed using Denver (Denver Developmental Screening Test) II when the child is 6 months old. | when the child is 6 months old. | 
| Child development | Child development as assessed using Denver (Denver Developmental Screening Test) II when the child is 12 months old. | when the child is 12 months old. | 
| Child development | Child development as assessed using Denver (Denver Developmental Screening Test) II when the child is 24 months old. | when the child is 24 months old. | 
| Premature birth | Premature birth as assessed by asking the mother whether the child was delivered before 37 weeks. | when the child is 6 weeks old. | 
| Delayed growth | Delayed growth measured by a physical examination of the child when the child is 6 months old. A physical examination of the child is conducted to measure the child's height, weight, and head circumference. | when the child is 6 months old. | 
| Delayed growth | Delayed growth measured by a physical examination of the child when the child is 12 months old. A physical examination of the child is conducted to measure the child's height, weight, and head circumference. | when the child is 12 months old. | 
| Delayed growth | Delayed growth measured by a physical examination of the child when the child is 24 months old. A physical examination of the child is conducted to measure the child's height, weight, and head circumference. | when the child is 24 months old. | 
| Knowledge on SIDS (sudden infant death syndrome) prevention | Knowledge of SIDS (sudden infant death syndrome) prevention as measured by the number of questions the mother answered correctly about SIDS prevention when the child is 6 months old. The questionnaire testing the mother's knowledge of SIDS is composed of five items from the Korean National Health Insurance Service's Infant Health Examination Questionnaire. | when the child is 6 months old. | 
| Vaccination | Vaccination as assessed by the completion of recommended vaccinations (tuberculosis, hepatitis B, Haemophilus influenzae type b (Hib), DTaP, polio, Streptococcus pneumoniae) when the child is 6 months old. | when the child is 6 months old. | 
| Vaccination | Vaccination as assessed by the completion of recommended vaccinations (tuberculosis, hepatitis B, Haemophilus influenzae type b (Hib), DTaP, polio, Streptococcus pneumoniae) when the child is 12 months old. | when the child is 12 months old. | 
| Vaccination | Vaccination as assessed by the completion of recommended vaccinations (tuberculosis, hepatitis B, Haemophilus influenzae type b (Hib), DTaP, polio, Streptococcus pneumoniae) when the child is 24 months old. | when the child is 24 months old. | 
| National health checkup | National health checkup assessed by asking whether the mother has visited a health center or pediatrician for an infant health checkup when the child is 6 months old. | when the child is 6 months old. | 
| National health checkup | National health checkup assessed by asking whether the mother has visited a health center or pediatrician for an infant health checkup when the child is 12 months old. | when the child is 12 months old. | 
| National health checkup | National health checkup assessed by asking whether the mother has visited a health center or pediatrician for an infant health checkup when the child is 24 months old. | when the child is 24 months old. | 
| Spouse's participation in parenting | Spouse's participation in parenting as measured by a questionnaire composed of 4 items when the child is 6 months old. The questionnaire was developed by Hong (1995) and used in the Panel Study on Korean Children (PSKC). The minimum score is 4 and the maximum score is 20, and a higher score means a better outcome. | when the child is 6 months old. | 
| Spouse's participation in parenting | Spouse's participation in parenting as measured by a questionnaire composed of 4 items when the child is 12 months old. The questionnaire was developed by Hong (1995) and used in the Panel Study on Korean Children (PSKC). The minimum score is 4 and the maximum score is 20, and a higher score means a better outcome. | when the child is 12 months old. | 
| Spouse's participation in parenting | Spouse's participation in parenting as measured by a questionnaire composed of 4 items when the child is 24 months old. The questionnaire was developed by Hong (1995) and used in the Panel Study on Korean Children (PSKC). The minimum score is 4 and the maximum score is 20, and a higher score means a better outcome. | when the child is 24 months old. | 
| Parenting related household expenses | Parenting-related household expenses, which measure a household's expenditures for pregnancy, childbirth, and supplies needed to care for the child when the child is 6 months old. | when the child is 6 months old. | 
| Parenting related household expenses | Parenting-related household expenses, which measure a household's expenditures for pregnancy, childbirth, and supplies needed to care for the child when the child is 12 months old. | when the child is 12 months old. | 
| Parenting related household expenses | Parenting-related household expenses, which measure a household's expenditures for pregnancy, childbirth, and supplies needed to care for the child when the child is 24 months old. | when the child is 24 months old. | 
| Depression (EPDS) | Depression as assessed using the EPDS (Edinburgh Postnatal Depression Scale) when the child is 6 months old. The EPDS (Edinburgh Postnatal Depression Scale) was developed by Cox et al. (1987) as a tool measuring postnatal depression. It is composed of 10 items. The minimum score is 0 and the maximum score is 30, and a higher score means a worse outcome. | when the child is 6 months old. | 
| Depression (EPDS) | Depression as assessed using the EPDS (Edinburgh Postnatal Depression Scale) when the child is 12 months old. The EPDS (Edinburgh Postnatal Depression Scale) was developed by Cox et al. (1987) as a tool measuring postnatal depression. It is composed of 10 items. The minimum score is 0 and the maximum score is 30, and a higher score means a worse outcome. | when the child is 12 months old. | 
| Depression (EPDS) | Depression as assessed using the EPDS (Edinburgh Postnatal Depression Scale) when the child is 24 months old. The EPDS (Edinburgh Postnatal Depression Scale) was developed by Cox et al. (1987) as a tool measuring postnatal depression. It is composed of 10 items. The minimum score is 0 and the maximum score is 30, and a higher score means a worse outcome. | when the child is 24 months old. | 
| Depression (PHQ-9) | Depression as assessed using the PHQ-9 (Patient Health Questionnaire-9) when the child is 6 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 6 months old. | 
| Depression (PHQ-9) | Depression as assessed using the PHQ-9 (Patient Health Questionnaire-9) when the child is 12 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 12 months old. | 
| Depression (PHQ-9) | Depression as assessed using the PHQ-9 (Patient Health Questionnaire-9) when the child is 24 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 24 months old. | 
| Anxiety | Anxiety level as assessed using the GAD-2 (Generalized Anxiety Disorder 2-item) when the child is 6 months old. The GAD-2 (Generalized Anxiety Disorder 2-item) is a 2-item questionnaire that measures core anxiety symptoms. The minimum score is 0 and the maximum score is 6, and higher score means a worse outcome. | when the child is 6 months old. | 
| Anxiety | Anxiety level as assessed using the GAD-2 (Generalized Anxiety Disorder 2-item) when the child is 12 months old. The GAD-2 (Generalized Anxiety Disorder 2-item) is a 2-item questionnaire that measures core anxiety symptoms. The minimum score is 0 and the maximum score is 6, and higher score means a worse outcome. | when the child is 12 months old. | 
| Anxiety | Anxiety level as assessed using the GAD-2 (Generalized Anxiety Disorder 2-item) when the child is 24 months old. The GAD-2 (Generalized Anxiety Disorder 2-item) is a 2-item questionnaire that measures core anxiety symptoms. The minimum score is 0 and the maximum score is 6, and higher score means a worse outcome. | when the child is 24 months old. | 
| Maternal tobacco use | Maternal tobacco use assessed by current tobacco use status when the child is 6 months old. Maternal tobacco use is assessed by questioning the participants about their current tobacco use behavior during the month before the study. | when the child is 6 months old. | 
| Maternal tobacco use | Maternal tobacco use assessed by current tobacco use status when the child is 12 months old. Maternal tobacco use is assessed by questioning the participants about their current tobacco use behavior during the month before the study. | when the child is 12 months old. | 
| Maternal tobacco use | Maternal tobacco use assessed by current tobacco use status when the child is 24 months old. Maternal tobacco use is assessed by questioning the participants about their current tobacco use behavior during the month before the study. | when the child is 24 months old. | 
| Maternal alcohol consumption | Maternal alcohol consumption when the child is 6 months old. Maternal alcohol consumption is assessed by questioning the participants about their drinking behavior during the month before the study. | when the child is 6 months old. | 
| Maternal alcohol consumption | Maternal alcohol consumption when the child is 12 months old. Maternal alcohol consumption is assessed by questioning the participants about their drinking behavior during the month before the study. | when the child is 12 months old. | 
| Maternal alcohol consumption | Maternal alcohol consumption when the child is 24 months old. Maternal alcohol consumption is assessed by questioning the participants about their drinking behavior during the month before the study. | when the child is 24 months old. | 
| Delivery type | Delivery type as assessed by asking a mother to choose her delivery type between normal delivery, planned C-section, and unplanned emergency C-section when the child is 6 weeks old. | when the child is 6 weeks old. | 
| Maternal parenting stress | Maternal parenting stress as assessed using the Being a Mother Scale (BaM-13) when the child is 6 months old. The Being a Mother Scale (BaM-13) was developed by Matthey (2011) for assessing mothers' level of distress. It is composed of 13 items. The minimum score is 0 and the maximum score is 39, and a higher score means a high level of distress. | when the child is 6 months old. | 
| Maternal parenting stress | Maternal parenting stress as assessed using the Being a Mother Scale (BaM-13) when the child is 12 months old. The Being a Mother Scale (BaM-13) was developed by Matthey (2011) for assessing mothers' level of distress. It is composed of 13 items. The minimum score is 0 and the maximum score is 39, and a higher score means a high level of distress. | when the child is 12 months old. | 
| Maternal parenting stress | Maternal parenting stress as assessed using the Being a Mother Scale (BaM-13) when the child is 24 months old. The Being a Mother Scale (BaM-13) was developed by Matthey (2011) for assessing mothers' level of distress. It is composed of 13 items. The minimum score is 0 and the maximum score is 39, and a higher score means a high level of distress. | when the child is 24 months old. | 
| Intimate partner violence | Intimate partner violence as assessed using the HITS (Hurt, Insult, Threaten, and Scream) tool when the child is 6 months old. The HITS (Hurt, Insult, Threaten, and Scream) tool was developed by Sherin et al. (1998) for assessing the level of domestic violence. It is composed of 4 items. The minimum score is 4 and the maximum score is 20, and higher score means a high level of domestic violence. | when the child is 6 months old. | 
| Intimate partner violence | Intimate partner violence as assessed using the HITS (Hurt, Insult, Threaten, and Scream) tool when the child is 12 months old. The HITS (Hurt, Insult, Threaten, and Scream) tool was developed by Sherin et al. (1998) for assessing the level of domestic violence. It is composed of 4 items. The minimum score is 4 and the maximum score is 20, and higher score means a high level of domestic violence. | when the child is 12 months old. | 
| Intimate partner violence | Intimate partner violence as assessed using the HITS (Hurt, Insult, Threaten, and Scream) tool when the child is 24 months old. The HITS (Hurt, Insult, Threaten, and Scream) tool was developed by Sherin et al. (1998) for assessing the level of domestic violence. It is composed of 4 items. The minimum score is 4 and the maximum score is 20, and higher score means a high level of domestic violence. | when the child is 24 months old. | 
| Maternal body weight | Maternal body weight when the child is 6 months old. | when the child is 6 months old. | 
| Maternal body weight | Maternal body weight when the child is 12 months old. | when the child is 12 months old. | 
| Maternal body weight | Maternal body weight when the child is 24 months old. | when the child is 24 months old. | 
| Social support | Social support as measured by a questionnaire developed by the Korea Institute of Child Care and Education when the child is 6 months old. The questionnaire measuring social support developed and used by Korea Institute of Child Care and Education is composed of 12 items. The minimum score is 12 and the maximum score is 60, and a higher score means a better outcome. | when the child is 6 months old. | 
| Social support | Social support as measured by a questionnaire developed by the Korea Institute of Child Care and Education when the child is 12 months old. The questionnaire measuring social support developed and used by Korea Institute of Child Care and Education is composed of 12 items. The minimum score is 12 and the maximum score is 60, and a higher score means a better outcome. | when the child is 12 months old. | 
| Social support | Social support as measured by a questionnaire developed by the Korea Institute of Child Care and Education when the child is 24 months old. The questionnaire measuring social support developed and used by Korea Institute of Child Care and Education is composed of 12 items. The minimum score is 12 and the maximum score is 60, and a higher score means a better outcome. | when the child is 24 months old. | 
| Food insecurity | Food insecurity assessed by asking about the family's level of limited access to adequate food over the past year when the child is 12 months. | when the child is 12 months old. | 
| Food insecurity | Food insecurity assessed by asking about the family's level of limited access to adequate food over the past year when the child is 24 months. | when the child is 24 months old. | 
| Spouse intimacy | Spouse intimacy as measured using the Revised-Kansas Marital Satisfaction Scale modified by the Korea Institute of Child Care and Education when the child is 6 months old. The Revised-Kansas Marital Satisfaction Scale modified by the Korea Institute of Child Care and Education is composed of 4 items. The minimum score is 4 and the maximum score is 20, and higher score means a better outcome. | when the child is 6 months old. | 
| Spouse intimacy | Spouse intimacy as measured using the Revised-Kansas Marital Satisfaction Scale modified by the Korea Institute of Child Care and Education when the child is 12 months old. The Revised-Kansas Marital Satisfaction Scale modified by the Korea Institute of Child Care and Education is composed of 4 items. The minimum score is 4 and the maximum score is 20, and higher score means a better outcome. | when the child is 12 months old. | 
| Spouse intimacy | Spouse intimacy as measured using the Revised-Kansas Marital Satisfaction Scale modified by the Korea Institute of Child Care and Education when the child is 24 months old. The Revised-Kansas Marital Satisfaction Scale modified by the Korea Institute of Child Care and Education is composed of 4 items. The minimum score is 4 and the maximum score is 20, and higher score means a better outcome. | when the child is 24 months old. | 
| Spouse tobacco use | Spouse tobacco use assessed by current tobacco use status when the child is 6 months old. Spouse tobacco use is assessed by questioning participants about their spouse's current tobacco use behavior during the month before the study. | when the child is 6 months old. | 
| Spouse tobacco use | Spouse tobacco use assessed by current tobacco use status when the child is 12 months old. Spouse tobacco use is assessed by questioning participants about their spouse's current tobacco use behavior during the month before the study. | when the child is 12 months old. | 
| Spouse tobacco use | Spouse tobacco use assessed by current tobacco use status when the child is 24 months old. Spouse tobacco use is assessed by questioning participants about their spouse's current tobacco use behavior during the month before the study. | when the child is 24 months old. | 
| Spouse alcohol consumption | Spouse alcohol consumption when the child is 6 months old. Spouse alcohol consumption is assessed by questioning participants about their spouse's drinking behavior during the month before the study. | when the child is 6 months old. | 
| Spouse alcohol consumption | Spouse alcohol consumption when the child is 12 months old. Spouse alcohol consumption is assessed by questioning participants about their spouse's drinking behavior during the month before the study. | when the child is 12 months old. | 
| Spouse alcohol consumption | Spouse alcohol consumption when the child is 24 months old. Spouse alcohol consumption is assessed by questioning participants about their spouse's drinking behavior during the month before the study. | when the child is 24 months old. | 
| Parent-child interaction | Parent-child interaction as assessed by using the NCAST (Nursing Child Assessment Teaching Scale) when the child is 12 months old. The NCAST (Nursing Child Assessment Teaching Scale) was developed by Barnard (1989) for assessing parent-child interaction. It is composed of 73 items that measure sensitivity to cues, response to child's distress, cognitive growth fostering, clarity of cues, and responsiveness to caregiver. The minimum score is 0 and the maximum score is 105, and a higher score means a better outcome. | when the child is 12 months old. | 
| Parent-child interaction | Parent-child interaction as assessed by using the NCAST (Nursing Child Assessment Teaching Scale) when the child is 24 months old. The NCAST (Nursing Child Assessment Teaching Scale) was developed by Barnard (1989) for assessing parent-child interaction. It is composed of 73 items that measure sensitivity to cues, response to child's distress, cognitive growth fostering, clarity of cues, and responsiveness to caregiver. The minimum score is 0 and the maximum score is 105, and a higher score means a better outcome. | when the child is 24 months old. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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