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

Mental Health Issue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04873518
• Other study ID #: MP-21-2017-1461
• Secondary ID: PJT-148551PJT-16
• Status: Active, not recruiting
• Start date: May 1, 2017
• Est. completion date: December 21, 2022

Study information

• Verified date: May 2022
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 939
• Est. completion date: December 21, 2022
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Canada	CHU Ste-Justine Research Center	Montréal	Quebec
Canada	CHU de Quebec-Universite Laval	Québec	Quebec
Canada	Université de Sherbrooke	Sherbrooke	Quebec

Sponsors (6)

Lead Sponsor	Collaborator
St. Justine's Hospital	Canadian Institutes of Health Research (CIHR), CHU de Quebec-Universite Laval, Laval University, Université de Montréal, Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Leblond M, Parent S, Castellanos-Ryan N, Lupien SJ, Fraser WD, Séguin JR. Transition from preschool to school: Children's pattern of change in morning cortisol concentrations. Psychoneuroendocrinology. 2022 Mar 14;140:105724. doi: 10.1016/j.psyneuen.2022. — View Citation

Parent S, Lupien S, Herba CM, Dupéré V, Gunnar MR, Séguin 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. Review. — View Citation

Rioux C, Parent S, Castellanos-Ryan N, Archambault I, Boivin M, Herba CM, Lupien SJ, Marc I, Muckle G, Fraser WD, Séguin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Neurodevelopment - Change in executive function	Change in one latent factor score of executive function based on the following tasks: Dimensional Change Card Sort (DCCS) measuring degree of cognitive flexibility; Random Object Span Task (ROST), a child version of the Self-Ordered Pointing (SOP) test measuring degree of working memory.; Wechsler's Digit Span subtest measuring degree of working memory.	Yearly, across 3 years: in Pre-Kindergarten, Kindergarten and Grade 1
Primary	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
Primary	Neurodevelopment - Change in visuo-motor integration	Change on the Beery Visuo-Motor integration subtest.	Yearly, across 2 years: in Pre-Kindergarten and in Kindergarten
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Academic skills scores - Change in academic performance.	Change in teacher reports on child academic achievement.	Yearly, across 2 years: in Grades 1 and 2
Primary	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)