Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-24 @ 7:15 PM
NCT ID:
NCT02800603
Eligibility Criteria:
Inclusion Criteria: Screening eligibility criteria include:
1. Custodial caregivers of a child aged 2 years, 0 months to 4 years, 11 months.
2. Definition of "at-risk" for child EBP as measured by (a) OR (b):
* Elevated child EBP as indexed by above-population mean total scores on Strengths and Difficulties Questionnaire (SDQ), plus one of the following family or contextual risk factors
* Caregiver challenges: teen parent status, caregiver mental health problems (as indexed by K6 psychological distress scale), lone caregiver
* Sociodemographic risk factors (as indexed by the 2014 Ontario Child Health Study (OCHS) demographics questionnaire): family income below low-income cut-off (LICO), caregiver with less than grade 12 education, caregiver on social assistance.
* Families who score within norms on caregiver or sociodemographic risk AND child SDQ scores fall within the "high" range, indicating significant burden of EBP (and thus increased risk of persistent, severe problems over time).
3. Caregivers with sufficient knowledge of English needed for assessment measures
4. Caregivers capable of giving informed, written consent
Exclusion Criteria:
1. Children with suspected severe to profound developmental delay
2. Current enrolment in another clinical intervention trial
3. Caregiver or child with a serious medical condition that, based on Investigator judgment, might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
4 Years
Study:
NCT02800603
Study Brief:
Protocol Section:
NCT02800603