NCT03856931

Brief Summary

In this TARGet Kids! Study, we want to find out whether a short questionnaire can be used to help find out about mental health problems in preschool age children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 20, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

3.1 years

First QC Date

February 26, 2019

Last Update Submit

January 6, 2025

Conditions

Keywords

mental healthpreschoolSDQparental depression

Outcome Measures

Primary Outcomes (1)

  • Total difficulties score

    As measured by the preschool strengths and difficulties questionnaire (P-SDQ)

    3 months

Eligibility Criteria

Age2 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

TARGet Kids! (The Applied Research Group for Kids) is a research project enrolling healthy children aged 0-5 years during their primary-care health supervision visits with their primary care physician who is a Community Physician Collaborator with the TARGetKids! primary-care practice-based research network. The BeEPS study will recruit participants from within the TARGet Kids! cohort.

You may qualify if:

  • Child is between age 2 to 4 years.
  • Parent is the primary caretaker for the child and is able to speak, read and understand English well enough to complete the forms and the PAPA interview.
  • Either one or both parents (primary caretakers) are available to participate in the study.

You may not qualify if:

  • Children with associated health conditions affecting growth (e.g. failure to thrive, cystic fibrosis);
  • Children with any acute or chronic conditions except for asthma and high functioning autism;
  • Children with severe developmental delay;
  • Children with a gestational age of less than 32 weeks;
  • Families who are not fluent in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Mental DisordersDepression, PostpartumPsychological Well-Being

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersPersonal SatisfactionBehavior

Study Officials

  • Alice Charach, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Psychiatrist

Study Record Dates

First Submitted

February 26, 2019

First Posted

February 27, 2019

Study Start

February 20, 2019

Primary Completion

March 31, 2022

Study Completion

September 30, 2022

Last Updated

January 8, 2025

Record last verified: 2025-01

Locations