3D-Transition: Challenges and Resources of Children and Their Families During the Transition From Preschool to School

NCT ID: NCT04873518

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 939 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2022-12-21

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.

Conditions

Mental Health Issue; Externalizing Behavior Problems; Internalizing Behavior Problems; Cognitive Development; Neurodevelopmental Disorders; Academic Achievement

Study Design

• Observational Model Type: FAMILY_BASED
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1

These are the eldest children who entered kindergarten in September 2016.

No interventions assigned to this group

Cohort 2

These children entered kindergarten in September 2017.

No interventions assigned to this group

Cohort 3

These are the youngest children who entered kindergarten in September 2018

No interventions assigned to this group

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: collaborator

Université de Montréal

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: collaborator

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jean Séguin

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean R. Séguin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CHU Ste-Justine Research Center and Université de Montréal

Sophie Parent, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CHU Ste-Justine Research Center and Université de Montréal

Natalie Castellanos-Ryan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CHU Ste-Justine Research Center and Université de Montréal

Locations

CHU Ste-Justine Research Center

Montreal, Quebec, Canada

CHU de Quebec-Universite Laval

Québec, Quebec, Canada

Université de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 30253327 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33987638 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35325645 (View on PubMed)

Other Identifiers

PJT-148551

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PJT-165824

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CRI-88413

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MP-21-2017-1461

Identifier Type: -

Identifier Source: org_study_id