3D-Transition Study: Challenges and Resources of Children and Their Families During the Transition From Preschool to School, in a Pregnancy Cohort

St. Justine's Hospital3 个研究点分布在 1 个国家目标入组 939 人开始时间: 2017年5月1日最近更新: 2022年5月12日

适应症

试验速览

阶段: 不适用
发起方
入组人数: 939
试验地点: 3
主要终点: Academic skills scores - Change in academic performance.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The 3D-Transition study is a follow-up of the 3D Cohort pregnancy study (NCT03113331, which covered from the 1st trimester of pregnancy to age 2 years) as the children transition into kindergarten and first grade. It aims at clarifying prenatal and preschool predictors of challenging and successful transitions to school as measured by mental health and academic outcomes.

详细描述

Broad goal: This study seeks to understand how early vulnerabilities (externalizing or internalizing symptoms, or low neurodevelopmental/academic skills) turn into a rate of 10-15% of externalizing and internalizing mental health problems in school-aged children.

Rationale: Several lines of research guide this study. Functional impairments emerge for some children challenged by the transition to kindergarten and grade school. This risk is also thought to be programmed very early in life through cumulative early perinatal and psychosocial adversity. Further, interactions between the child, family and school environment during the transition may mitigate future impairments and this may be different for boys and girls. Finally, stress regulation mechanisms during the transition seem linked to early child vulnerabilities. This design allows us to contrast any combination of these mechanisms.

Aims: This study will clarify the role of:

a mismatch between some child preschool vulnerability (externalizing, or internalizing symptoms, or low neurodevelopmental/academic skills) and the challenges of the transition from preschool to formal schooling;
the experience of perinatal adversity and home chaos during child first years;
supportive environments (high quality families or schools) during the school transition, and child sex; and
the child stress response to the school transition, as assessed through salivary cortisol.

Method: Building on an existing pregnancy cohort (NCT03113331, which was structured around a triadic (mother-partner-child) framework, and which covered from the 1st trimester of pregnancy to age 2 years), the investigators have followed at least once 939 of 1551 families that agreed to a further follow-up past the initial study. Children in this cohort, who were seen in 3 waves based on age on September 30th, entered kindergarten in the fall of 2016, 2017, and 2018, respectively. A cohort-sequential longitudinal research design spanning pre-kindergarten to 2nd grade (ages 4 to 8 years), was implemented to follow each wave 6 times over 4 years. Cascade models will be used to address aims 1-3. The stress hormone cortisol will be examined on 11 days spread over a 16 months period for a subsample of 384 children to address aim 4, using growth curves models. This design is well suited and sufficiently powered to examine change processes over time, controlling for potential differences in waves and time of measurement effects.

研究设计

研究类型: Observational
观察模型: Family Based
时间视角: Prospective

入排标准

年龄范围: 4 Years 至 10 Years（Child）
性别: All
接受健康志愿者: 是

入选标准

•All participating families from Clinical Trials NCT03113331 who had accepted a follow-up past the original pregnancy to age 2-years time span of that protocol.

排除标准

•None for this follow up. See Clinical Trials NCT03113331 for original exclusion criteria.

结局指标

主要结局

Academic skills scores - Change in academic performance.

时间窗: Yearly, across 2 years: in Grades 1 and 2

Change in teacher reports on child academic achievement.

Neurodevelopment - Change in executive function