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临床试验/NCT05445518
NCT05445518已完成不适用

Jump Start Plus: Coronavirus Disease (COVID-19) Support to Improve Resiliency and Mitigate Risks in Childcare Centers Serving Children From Low-income Ethnic Minority Backgrounds.

University of Miami1 个研究点 分布在 1 个国家目标入组 1,505 人开始时间: 2022年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,505
试验地点
1
主要终点
Change in Strengths and Difficulties Questionnaire Scores

研究概览

简要总结

The purpose of the study is to further develop and examine the Jump Start Plus COVID Support (JS+CS) program, which encourages improved psychosocial functioning by promoting resiliency in childcare centers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Center Inclusion Criteria:
  • •Have greater than 30 children ages 2- to 5-years old
  • •Serve low-income families
  • •Reflect the ethnic diversity of Miami-Dade County (60%Hispanic, 20% Non-Hispanic Black, 20% Non-Hispanic White
  • •Child Inclusion Criteria:
  • •Child ages 2-5 years old
  • •Child enrolled in a childcare center

排除标准

  • •Children with feeding tubes or those that bring their own meals.

研究组 & 干预措施

Jump Start Plus COVID Support (JS+CS) Group

Experimental

Participants in this group will receive the Jump Start Plus COVID Support intervention for 24 months.

干预措施: Jump Start Plus COVID Support (Behavioral)

Healthy Caregivers-Healthy Children (HC2) Control Group

Active Comparator

Participants in this group will receive the Healthy Caregivers-Healthy Children intervention for 24 months.

干预措施: Healthy Caregivers-Healthy Children (HC2) (Behavioral)

结局指标

主要结局

Change in Strengths and Difficulties Questionnaire Scores

时间窗: Baseline, Up to 3 years

The Strengths and Difficulties Questionnaire is a total difficulties score that ranges from 0 to 40 with higher scores indicating less child behavior concerns.

Change in Health Environment Rating Scale Scores

时间窗: Baseline, Up to 3 years

The Health Environment Rating Scale has a total score ranging from 0 to 70 with higher scores indicating healthier practices

Change in Devereux Early Childhood Assessments Scores

时间窗: Baseline, Up to 3 years

The Devereux Early Childhood Assessments is a measure with a range of score from 0 to 100 with higher score on Behavior Concerns indicating more problem behaviors and a lower score on Initiative, Self-Control, Attachment indicated better protective factors.

次要结局

  • Change in Brief Resilient Coping Scale Scores(Baseline, Up to 3 years)
  • Change in Every Day Stressors Index Scores(Baseline, Up to 3 years)
  • Change in Teacher Opinion Survey(Baseline, up to 3 years)
  • Change in Childcare Worker Job Stress Index Scores(Baseline, Up to 3 years)
  • Change in Healthy Caregivers-Healthy Children Survey(Baseline, Up to 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruby Natale

Associate Professor of Clinical Pediatrics

University of Miami

研究点 (1)

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