- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03856931
Behaviours and Emotions in Preschoolers (BeEPS)
Behaviours and Emotions in Preschoolers - Detecting Mental Health Problems in Preschool Children in a Primary Care Population
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total difficulties score
Time Frame: 3 months
|
As measured by the preschool strengths and difficulties questionnaire (P-SDQ)
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alice Charach, MD, The Hospital for Sick Children
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000056960
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post Partum Depression
-
Duke UniversityNot yet recruitingPost Partum | Maternal Depression | Maternal Depression and Parent Practices, PostpartumUnited States
-
Washington University School of MedicineNurses for Newborns FoundationCompletedPost-partum DepressionUnited States
-
NYU Langone HealthWithdrawn
-
Curio Digital Therapeutics, Inc.RecruitingPost-partum DepressionUnited States
-
The University of Hong KongHospital Authority, Hong Kong; Kwong Wah HospitalCompleted
-
University of RochesterNational Institute of Mental Health (NIMH)Completed
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Not yet recruitingPost-partum DepressionItaly
-
Federal University of PelotasCompletedPrematurity | Gestational Hypertension | Maternal Post-partum Depression | Maternal Post-partum Weight Retention | Child's DevelopmentBrazil
-
Children's Hospital of PhiladelphiaNational Institute of Mental Health (NIMH)Recruiting