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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03856931
Other study ID # 1000056960
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 20, 2019
Est. completion date September 30, 2022

Study information

Verified date October 2021
Source TARGetKids!
Contact Dalah Mason, MPH
Phone 416-813-2129
Email dalah.mason@sickkids.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date September 30, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 4 Years
Eligibility 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.

Study Design


Locations

Country Name City State
Canada The Hospital for Sick Children Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
TARGetKids! The Hospital for Sick Children, Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total difficulties score As measured by the preschool strengths and difficulties questionnaire (P-SDQ) 3 months
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