Evaluation of the Impact of the CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Receptive vocabulary assessment at 12 months
研究概览
简要总结
Disparities in health begin in early childhood. Early life experiences influence brain development and have significant implications on future health and developmental outcomes. Low-income children are at greater risk of developmental delays in large part due to a lack of an enriched environment. Disparities in early childhood development increase risk for stunted academic achievement throughout the life course. Primary care is a universal exposure in early childhood and therefore is also a significant entry point for promoting optimal child development.
There is a need to provide effective, low-cost, and scalable interventions in primary care to support early childhood development.The CenteringParenting intervention is designed to reduce negative health and developmental outcomes within a model of group routine child health care. To date, there is no evidence of the benefits of the CenteringParenting intervention on school readiness, or improvements in parental behaviors that support optimal developmental milestones and achievement. The intent of this study is to determine the effectiveness of the CenteringParenting intervention on school readiness in early childhood, as measured by language development at 24 months, (in addition to health care utilization, child routine care maintenance, parenting stress, caregiver behaviors and attitudes).
详细描述
Children raised in environments with limited stimulation and lack of exposure to positive interactions are likely to have developmental delays in expressive and receptive language, vocabulary, social skills, behavior-all factors critical for school readiness. Children who enter kindergarten underprepared are more likely to struggle academically and experience lower school achievement, and ultimately impaired opportunities for economic and social mobility as adults.
The CenteringParenting intervention is designed to reduce negative health and developmental outcomes within a model of group routine child health care. This bundled intervention supports healthy parent-child interactions and early learning through education and experiential learning within a group well-child visit model. The intervention reduces social isolation and creates a community of support for caregivers, as well as utilizes a positive parenting approach to empowering parents with knowledge and skills to support optimal child development. The CenteringParenting intervention includes written materials provided at an annual clinical visit, as well as specific training for the facilitators/providers. To date, there is no research evidence of the benefits of the CenteringParenting intervention on school readiness, or improvements in parental behaviors that support optimal developmental milestones and achievement.
Study Design: A multi-site, cluster randomized controlled trial evaluating the impact of the CenteringParenting clinical intervention on kindergarten readiness, as measured by expressive and receptive language and vocabulary at 24 months of age.
Objective Hypothesis: Compared to those receiving standard routine health care, the CenteringParenting intervention will result in improved language development at age 2 years and increased parental behaviors to encourage reading, talking and playing.
Specific Aim 1: In a cluster randomized controlled trial, assess the effectiveness and implementation of the CenteringParenting intervention. Specific Aim 2: Evaluate the fidelity of the implementation of the CenteringParenting intervention. Specific Aim 3: Evaluate caregivers' experience and engagement with the CenteringParenting intervention model and explore the relation between degree of engagement and development stimulating behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For participating practice sites
- •Practice provides care to patients who are covered by public insurance and/or uninsured (no minimum threshold: all insurance types eligible)
- •Practices have at least 3,000 primary care visits per year
- •For parent-child dyad
- •Index child age must be 0-3 months
- •Parent must be female
- •Parent must be 18 years of age and older
- •Parent and child must attend one of the 10 study clinical sites
- •Parental consent
- •Parent must be fluent in English or Spanish
排除标准
- •For participating practice sites
- •Does not accept public insurance
- •For parent-child dyad
- •Child born prior to 34 weeks gestation
- •Child with chronic conditions known to affect neurodevelopment
- •Child with a positive screen on the Children with Special Healthcare Needs screener
结局指标
主要结局
Receptive vocabulary assessment at 12 months
时间窗: 12 months
Assess Receptive vocabulary based on the Preschool Language Scale-5 (PLS-5) 5th Edition Parent Questionnaire. The scale accesses: Total language, auditory comprehension, expressive communication standard scores, growth scores, percentile ranks, language age equivalents. PLS-5 scores range anywhere from 40-160 with the mean being 100 and an SD of 15. Higher percentile ranks are correlated with higher the levels of receptive vocabulary. Administered by research assistant to female guardian.
Receptive vocabulary assessment at 24 months
时间窗: 24 months
Assess Receptive vocabulary based on the Preschool Language Scale-5 (PLS-5) 5th Edition Parent Questionnaire. The scale accesses: Total language, auditory comprehension, expressive communication standard scores, growth scores, percentile ranks, language age equivalents. PLS-5 scores range anywhere from 40-160 with the mean being 100 and an SD of 15. Higher percentile ranks are correlated with higher the levels of receptive vocabulary. Administered by research assistant to female guardian.
Early language assessment at 24 months
时间窗: 24 months
Assess early language (vocabulary, comprehension, production, gestures and grammar) based on the MacArthur Communicative Development Inventories (CDI). Two equivalent Words \& Sentences versions (Level IIA and Level IIB) contain a 100-word productive vocabulary checklist and a question about combining words, appropriate for children 16-30 months. The score is assessed in the amount of correct answers and measured in percentiles, from \<1th to 100th, depending on the child's age. Administered by research assistant to female guardian.
Early language assessment at 12 months
时间窗: 12 months
Assess early language (vocabulary, comprehension, production, gestures and grammar) based on the MacArthur Communicative Development Inventories (CDI). The Words and Gestures short form (Level I) is comprised of a 89-word vocabulary checklist with separate columns for comprehension and production, appropriate for children 8-18 months. The score is assessed in the amount of correct answers and measured in percentiles, from \<1th to 100th, depending on the child's age. Administered by research assistant to female guardian.
Receptive vocabulary assessment at 3 months
时间窗: 3 months
Assess Receptive vocabulary based on the Preschool Language Scale-5 (PLS-5) 5th Edition Parent Questionnaire. The scale accesses: Total language, auditory comprehension, expressive communication standard scores, growth scores, percentile ranks, language age equivalents. PLS-5 scores range anywhere from 40-160 with the mean being 100 and an SD of 15. Higher percentile ranks are correlated with higher the levels of receptive vocabulary. Administered by research assistant to female guardian.
次要结局
- Parental behavior at 24 months(24 months)
- Parental behavior at 12 months(12 months)