Clinical trial NCT04873518: 3D-Transition: Challenges and Resources of Children and Their Families During the Transition From Preschool to School
Official title: 3D-Transition Study: Challenges and Resources of Children and Their Families During the Transition From Preschool to School, in a Pregnancy Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Health Issue
Externalizing Behavior Problems
Internalizing Behavior Problems
Cognitive Development
Neurodevelopmental Disorders
Academic Achievement
Keywords: longitudinal
cohort-sequential
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Université de Sherbrooke
name: CHU de Quebec-Universite Laval
name: Université de Montréal
name: Laval University
First posted: 2021-05-05
Enrollment: 939
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population sample from the main university hospitals affiliated with the province of Québec, Canada's 4 faculties of medicine between November 2010 and March 2013, included.

Brief summary: 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.

Detailed description: 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:

1. 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;
2. the experience of perinatal adversity and home chaos during child first years;
3. supportive environments (high quality families or schools) during the school transition, and child sex; and
4. 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.

Additional data: The Research Ethics Committee authorized two Corona Virus (COVID-19) supplemental data collections without additional consent for the spring of 2020 and the spring of 2021. However, cohorts 1 and 2, which had completed participation in 2019 and 2020, were re-consented, and this extended the maximum age range to 10 and 9 years, respectively. As of 2022-05-03 investigators are in the process of requesting approval for an additional COVID-19 follow-up.

Expected outcomes: Public health interventions are being put in place to help children manage the transition to school on the basis of little evidence. This longitudinal research will provide a greater understanding of individual and environmental factors linked to children's adaptation during the perinatal period and transitions to school. As such, mental health prevention research will be better informed on the developmental timing of individual and environmental targets that need to be considered in a developmental framework.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Mental health: Change in child mental health represented by one latent symptom score of the overarching category: externalizing symptoms.
timeFrame: Six times across 4 years, in the spring during Pre-Kindergarten, then in the fall and spring of Kindergarten and Grade 1, then in the spring of Grade 2
measure: Mental health: Change in child mental health represented by one latent symptom score of the overarching category: internalizing symptoms.
timeFrame: Six times across 4 years, in the spring during Pre-Kindergarten, then in the fall and spring of Kindergarten and Grade 1, then in the spring of Grade 2
measure: Neurodevelopment - Change in executive function
timeFrame: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
measure: Neurodevelopment - Change in visuo-spatial ability
timeFrame: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
measure: Neurodevelopment - Change in visuo-motor integration
timeFrame: Yearly, across 2 years: in Pre-Kindergarten and in Kindergarten
measure: Neurodevelopment - Change in social cognition
timeFrame: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
measure: Neurodevelopment - Change in emotional development
timeFrame: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
measure: Academic skills scores - Change in school readiness
timeFrame: Yearly, across 2 years: in Pre-Kindergarten and Kindergarten
measure: Academic skills scores- Change in Number Knowledge abilities
timeFrame: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
measure: Academic skills scores - Change in receptive vocabulary
timeFrame: Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
measure: Academic skills scores - Change in Reading ability
timeFrame: Grade 1 only
measure: Academic skills scores - Change in academic performance.
timeFrame: Yearly, across 2 years: in Grades 1 and 2
measure: Change in Morning and evening salivary cortisol levels
timeFrame: Pre-Kindergarten to Grade 1 (Across a 16 months period from June in Year 1 to September in Year 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHU Ste-Justine Research Center
state: Quebec
city: Québec
country: Canada
facility: CHU de Quebec-Universite Laval
state: Quebec
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
Study officials:
affiliation: CHU Ste-Justine Research Center and Université de Montréal
name: Jean R. Séguin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Ste-Justine Research Center and Université de Montréal
name: Sophie Parent, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Ste-Justine Research Center and Université de Montréal
name: Natalie Castellanos-Ryan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parent S, Lupien S, Herba CM, Dupere V, Gunnar MR, Seguin JR. Children's cortisol response to the transition from preschool to formal schooling: A review. Psychoneuroendocrinology. 2019 Jan;99:196-205. doi: 10.1016/j.psyneuen.2018.09.013. Epub 2018 Sep 14.
citation: Rioux C, Parent S, Castellanos-Ryan N, Archambault I, Boivin M, Herba CM, Lupien SJ, Marc I, Muckle G, Fraser WD, Seguin JR. The 3D-Transition Study: Objectives, Methods, and Implementation of an Innovative Planned Missing-Data Design. Am J Epidemiol. 2021 Nov 2;190(11):2262-2274. doi: 10.1093/aje/kwab141.
citation: Leblond M, Parent S, Castellanos-Ryan N, Lupien SJ, Fraser WD, Seguin JR. Transition from preschool to school: Children's pattern of change in morning cortisol concentrations. Psychoneuroendocrinology. 2022 Jun;140:105724. doi: 10.1016/j.psyneuen.2022.105724. Epub 2022 Mar 14.