跳至主要内容
临床试验/NCT05444205
NCT05444205进行中(未招募)不适用

The Pittsburgh Study Early Childhood Collaborative

University of Pittsburgh10 个研究点 分布在 1 个国家目标入组 24,000 人开始时间: 2020年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
24,000
试验地点
10
主要终点
Child inhibitory control

研究概览

简要总结

The Early Childhood Collaborative of The Pittsburgh Study is a community-partnered, county-wide implementation of programs for children and families from birth through formal school entry to address real-world challenges that exist in providing effective preventive interventions for families with young children, particularly low-income families.

详细描述

The Early Childhood Collaborative of The Pittsburgh Study is a community-partnered, county-wide implementation of programs for children and families from birth through formal school entry to address real-world challenges that exist in providing effective preventive interventions for families with young children, particularly low-income families. Specifically, The Early Childhood Collaborative seeks to increase engagement (uptake and retention) in evidence-based interventions by (1) initially assessing families' resources and challenges, (2) offering families a menu of intervention options tailored to their resources/needs, and (3) providing these services at multiple locations to optimize accessibility. The Early Childhood Collaborative involves population-level utilization of multiple platforms that families, particularly families at greater risk for health disparities, typically use, including health care (birthing hospitals, pediatric care, federally qualified health centers), Women, Infants, and Children nutritional clinics, and family centers. The Early Childhood Collaborative will locate services in these platforms and at family's homes. The Early Childhood Collaborative focuses on child thriving and flourishing as key outcomes of interest, and community strengths as key drivers of change. To promote sustainability, investigators include representatives from the Departments of Human Services and Health who are responsible for funding and implementing home visiting programs in the greater Pittsburgh community, with the goal of generating infrastructures and capacity in existing community agencies for providing evidence-based behavioral health care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

盲法说明

The Early Childhood Collaborative is an implementation study and therefore, all participants are offered intervention and there in so masking.

入排标准

年龄范围
— 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Allegheny County Residency, legal custodian of child

排除标准

  • Non-English speaking

结局指标

主要结局

Child inhibitory control

时间窗: 4 years

Change in inhibitory control as measured using the 13-item Inhibitory Control scale of the Children's Behavior Questionnaire. Mean scores will be calculated with a possible range of 0-7 (higher scores indicate greater inhibitory control). Citation: Rothbart, M. K., Ahadi, S. A., Hershey, K. L. \& Fisher, P. (2001). Investigations of temperament at 3-7 years: The Children's Behavior Questionnaire. Child Development, 72(5), 1394-1408.

Parent Reading Behaviors - Infancy

时间窗: 4 years

Change in parent reading behaviors as measured using the StimQ self-report. We will use the 15-item reading factor. Scores used for outcome will be determined by our collaborator (and scale developer) Dr. Alan Mendelsohn and his research team at NYU. Citations: StimQ2-Infant©2016. NYU School of Medicine Alan L. Mendelsohn MD, Carolyn B. Cates PhD, Matthew Johnson, PhD, Adriana Weisleder PhD, Benard Dreyer MD

Socioemotional adjustment - ITSEA

时间窗: 4 years

Change in infant and toddler problem behaviors and socioemotional adjustment: Measured by the The infant-toddler social and emotional assessment (ITSEA). We will use the 14-item negative emotionality factor. Items are measured on a 3-point likert-type scale. A sum score will be calculated, with a possible range of 0-28 (higher scores indicate greater problems). Citations: Carter, A. S., Briggs-Gowan, M. J., Jones, S. M., \& Little, T. D. (2003). The infant-toddler social and emotional assessment (ITSEA): Factor structure, reliability, and validity. Journal of abnormal child psychology, 31(5), 495-514.

Socioemotional adjustment - BITSEA

时间窗: 4 years

Change in infant and toddler problem behaviors: Measured by a subset of 28 items derived from the Brief infant-toddler social and emotional assessment (BITSEA) Total Problems scale. Items are measured on a 3-point likert-type scale. A sum score will be calculated, with a possible range of 0-56 (higher scores indicate greater problems). Citation: Briggs-Gowan, M. J. \& Carter, A.S. (2006). BITSEA : Brief infant-toddler social and emotional assessment. San Antonio, TX: Pearson 2006.

Socioemotional adjustment - CBCL

时间窗: 4 years

Change in child problem behaviors and socioemotional adjustment: Measured by the Child Behavior Checklist (CBCL). We will use 60 items that comprise the Externalizing and Internalizing broadband factors. Items are measured on a 3-point Likert-type scale. A raw sum score will be calculated for each factor, with a possible range of 0-48 for Externalizing problems and 0-72 for Internalizing problems (higher scores indicate greater problems). We will also calculate t-scores for both scales. Citation: Achenbach, T. M. (2009). The Achenbach System of Empirically Based Assessment (ASEBA): Development, Findings, Theory, and Applications. Burlington, VT: University of Vermont Research Center for Children, Youth, \& Families.

次要结局

  • Positive parenting skills - PYT(4 years)
  • Harsh parenting(4 years)
  • Parent anxiety symptoms(4 years)
  • Positive parenting skills - PARYC(4 years)
  • Parent social support(4 years)
  • Parent depressive symptoms(4 years)
  • Well-child care(4 years)
  • Positive parenting skills - PYB(4 years)

研究者

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

Daniel Shaw

Professor

University of Pittsburgh

研究点 (10)

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