Mental Health WellnessBeEPSNCT03856931
Behaviours and Emotions in Preschoolers
An observational study of Mental Health Wellness and Emotional Problem, run by TARGetKids! at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 2 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness, Emotional Problem, Behavioural Problem
- How many people
- 183 participants
- Where
- 1 siteCanada
- Study dates
- 20 Feb 2019to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behaviours and Emotions in Preschoolers - Detecting Mental Health Problems in Preschool Children in a Primary Care Population
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.
Read the 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.
- Keywords
- mental health, preschool, SDQ, parental depression
- Medical subject headings
- Mental Disorders, Depression, Postpartum, Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
Total difficulties score
As measured by the preschool strengths and difficulties questionnaire (P-SDQ)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start20 Feb 2019
- Primary completion31 Mar 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health WellnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- TARGetKids!
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, Unity Health Toronto
- Responsible party
- Principal investigator, Alice Charach, The Hospital for Sick Children
- Investigators
- Alice Charach, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856931
- Sponsor's protocol ID
- 1000056960
- Acronym
- BeEPS
- Status last verified
- Jan 2025
- First submitted
- 26 Feb 2019
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behaviours and Emotions in Preschoolers - Detecting Mental Health Problems in Preschool Children in a Primary Care Population
- ClinicalTrials.gov ID
- NCT03856931
- Acronym / sponsor ID
- BeEPS / 1000056960
- Keywords
- mental health, preschool, SDQ, parental depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- TARGetKids!University, hospital or other
- Collaborators
- The Hospital for Sick Children, Unity Health Toronto
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total difficulties score
Time frame: 3 months
As measured by the preschool strengths and difficulties questionnaire (P-SDQ)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Charach, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Wellness and Emotional Problem, run by TARGetKids! at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total difficulties score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.