UnknownNot Applicable

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

Canada939 participantsStarted 2017-05-01

Plain-language 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.

Who can participate

Age range

4 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Neurodevelopment - Change in executive function

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

Neurodevelopment - Change in visuo-spatial ability

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

Neurodevelopment - Change in visuo-motor integration

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

Neurodevelopment - Change in social cognition

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

Trial details

NCT IDNCT04873518

SponsorSt. Justine's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-21

View on ClinicalTrials.gov More Mental Health Issue trials

Plain-language summary

Who can participate

Age range

4 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

Neurodevelopment - Change in executive function

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

Neurodevelopment - Change in visuo-spatial ability

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

Neurodevelopment - Change in visuo-motor integration

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

Neurodevelopment - Change in social cognition

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