NCT04873518

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
939

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2022

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

5.6 years

First QC Date

April 13, 2021

Last Update Submit

May 6, 2022

Conditions

Keywords

longitudinalcohort-sequential

Outcome Measures

Primary Outcomes (13)

  • Mental health: Change in child mental health represented by one latent symptom score of the overarching category: externalizing symptoms.

    The latent factor will be based on three informants which provide these mental health symptom ratings: mother-, father-, and teacher-reports as measured with age-appropriate non-overlapping items from the externalizing symptoms scales of: i) the Strengths and Difficulties Questionnaire (SDQ) ii) the Child Behavior Checklist (CBCL) iii) the Behavior scale of the Quebec Longitudinal Study of Child Development (QLSCD).

    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

  • Mental health: Change in child mental health represented by one latent symptom score of the overarching category: internalizing symptoms.

    The latent factor will be based on three informants which provide these mental health symptom ratings: mother-, father-, and teacher-reports as measured with age-appropriate non-overlapping items from the externalizing symptoms scales of: i) the Strengths and Difficulties Questionnaire (SDQ) ii) the Child Behavior Checklist (CBCL) iii) the Behavior scale of the Quebec Longitudinal Study of Child Development (QLSCD).

    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

  • Neurodevelopment - Change in executive function

    Change in one latent factor score of executive function based on the following tasks: 1. Dimensional Change Card Sort (DCCS) measuring degree of cognitive flexibility 2. Random Object Span Task (ROST), a child version of the Self-Ordered Pointing (SOP) test measuring degree of working memory. 3. Wechsler's Digit Span subtest measuring degree of working memory.

    Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1

  • Neurodevelopment - Change in visuo-spatial ability

    Change in visuo-spatial ability based on the Wechsler's Block Design subtest.

    Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1

  • Neurodevelopment - Change in visuo-motor integration

    Change on the Beery Visuo-Motor integration subtest.

    Yearly, across 2 years: in Pre-Kindergarten and in Kindergarten

  • Neurodevelopment - Change in social cognition

    Change in social cognition based on a latent factor of 1st and 2nd order Theory Of Mind (TOM) tests.

    Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1

  • Neurodevelopment - Change in emotional development

    Change on the Pons and Harris (2000) Test of Emotion Comprehension (TEC) score.

    Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1

  • Academic skills scores - Change in school readiness

    Change in the total score of The Lollipop Test comprising 4 dimensions: 1) Identification of Colors and Shapes, and Copying Shapes, 2) Picture Description, Position, and Spatial Recognition, 3) Identification of Numbers, and Counting, and 4) Identification of Letters, and Writing.

    Yearly, across 2 years: in Pre-Kindergarten and Kindergarten

  • Academic skills scores- Change in Number Knowledge abilities

    Change in a score combining The Number Knowledge Test (NKT) and the Mathematics subtest of the Canadian Achievement Test (CAT).

    Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1

  • Academic skills scores - Change in receptive vocabulary

    Change in the total score of the Peabody Picture Vocabulary Test (PPVT) in French or English versions.

    Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1

  • Academic skills scores - Change in Reading ability

    The Kaufman Assessment Battery for Children (K-ABC) reading ability test score in French or English versions.

    Grade 1 only

  • Academic skills scores - Change in academic performance.

    Change in teacher reports on child academic achievement.

    Yearly, across 2 years: in Grades 1 and 2

  • Change in Morning and evening salivary cortisol levels

    A subsample of 382 (out of 400 targeted) from cohorts 2 and 3 participated in a measurement burst design of 11 measurement days (2 samples/day), in June and August preceding entry into kindergarten (baseline), then twice one week apart at kindergarten entry in early September, then first Wednesday in each of November, February, and April. The following June, August, and early September measures were then repeated as the children moved towards entry to 1st grade.

    Pre-Kindergarten to Grade 1 (Across a 16 months period from June in Year 1 to September in Year 2)

Study Arms (3)

Cohort 1

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

Cohort 2

These children entered kindergarten in September 2017.

Cohort 3

These are the youngest children who entered kindergarten in September 2018

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Ste-Justine Research Center

Montreal, Quebec, H3T 1C5, Canada

Location

CHU de Quebec-Universite Laval

Québec, Quebec, G1V 4G2, Canada

Location

Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (3)

  • 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.

    PMID: 30253327BACKGROUND
  • 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.

    PMID: 33987638BACKGROUND
  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Salivary hormones in a subsample of 382 children

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Jean R. Séguin, Ph.D.

    CHU Ste-Justine Research Center and Université de Montréal

    PRINCIPAL INVESTIGATOR
  • Sophie Parent, Ph.D.

    CHU Ste-Justine Research Center and Université de Montréal

    PRINCIPAL INVESTIGATOR
  • Natalie Castellanos-Ryan, Ph.D.

    CHU Ste-Justine Research Center and Université de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

April 13, 2021

First Posted

May 5, 2021

Study Start

May 1, 2017

Primary Completion

December 21, 2022

Study Completion

December 21, 2022

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

The procedures by which de-identified data will be accessible are being clarified as rules and regulations are currently under study in this jurisdiction. In the meantime the investigators can be contacted for updates - see "More information"

Time Frame
Partial data from earlier waves may be available upon request. The bulk of the data should be available by March 2023.
Access Criteria
Data are under the jurisdiction of the Centre Hospitalier Universitaire (CHU) Ste-Justine Research Ethics Committee and subject to current provincial and national privacy laws guiding their ethical use in Québec, Canada. To submit a request, please visit the 3D-Cohort Study website or contact the principal investigator.
More information

Locations