BeEPS: Behaviours and Emotions in Preschoolers

Sponsor
TARGetKids! (Other)
Overall Status
Recruiting
CT.gov ID
NCT03856931
Collaborator
The Hospital for Sick Children (Other), Unity Health Toronto (Other)
300
1
43.3
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Research indicates that more than 1 in 10 preschoolers have significant social, emotional and behavioural problems also known as mental health problems. Unfortunately, parents and doctors rarely identify mental health problems in young children in order to begin treatment. We are testing a short five-minute questionnaire completed by parents to see if this may help a doctor notice if a child has social, emotional and behavioural problems.

    In addition, we also hope to find out if the presence of feelings of stress and depression in on or both parents may be associated with mental health problems in their preschool child.

    This study is being conducted by researchers at SickKids and St. Michael's Hospital.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Behaviours and Emotions in Preschoolers - Detecting Mental Health Problems in Preschool Children in a Primary Care Population
    Actual Study Start Date :
    Feb 20, 2019
    Anticipated Primary Completion Date :
    Mar 31, 2022
    Anticipated Study Completion Date :
    Sep 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Total difficulties score [3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 4 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Child is between age 2 to 4 years.

    2. 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.

    3. Either one or both parents (primary caretakers) are available to participate in the study.

    Exclusion Criteria:
    1. Children with associated health conditions affecting growth (e.g. failure to thrive, cystic fibrosis);

    2. Children with any acute or chronic conditions except for asthma and high functioning autism;

    3. Children with severe developmental delay;

    4. Children with a gestational age of less than 32 weeks;

    5. Families who are not fluent in English.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8

    Sponsors and Collaborators

    • TARGetKids!
    • The Hospital for Sick Children
    • Unity Health Toronto

    Investigators

    • Principal Investigator: Alice Charach, MD, The Hospital for Sick Children

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alice Charach, Staff Psychiatrist, The Hospital for Sick Children
    ClinicalTrials.gov Identifier:
    NCT03856931
    Other Study ID Numbers:
    • 1000056960
    First Posted:
    Feb 27, 2019
    Last Update Posted:
    Oct 14, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alice Charach, Staff Psychiatrist, The Hospital for Sick Children
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 14, 2021