NCT07091240 Pediatricians Building Resilience Through Early Identification for Toddler Well-Being
| NCT ID | NCT07091240 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Mental Health |
| Study Type | INTERVENTIONAL |
| Enrollment | 432 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2029-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 432 participants in total. It began in 2026-06-01 with a primary completion date of 2029-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this study, caregivers of toddlers with a high likelihood of developing mental health challenges will participate in a parenting program, Family Check-Up® Online (FCU-O), and complete assessments related to their child's behavior and their caregiving practices. FCU-O is a parenting support program that offers tools and guidance to support children's emotional and behavioral development. The program is delivered through a secure website that can be accessed via computer or phone at participating caregivers' convenience. Caregivers will complete the Developmental Early Childhood Instrument for Deciding Effectively about Mental Health (DECIDE) tool, a risk calculator that screens for early signs of future mental health challenges, at their child's 24- or 30-month well-check visit with their pediatrician. Clinicians will use the DECIDE tool risk calculator score to refer caregivers of at-risk children to FCU-O. Caregivers may use FCU-O independently, or they may work with a trained coach who will facilitate their use of the program. Participation is open to caregivers who are referred to FCU-O based on their DECIDE risk calculator score by their child's pediatrician, and is available in English or Spanish. Participants will also complete assessments via survey and direct observation before beginning FCU-O, and 6- and 12-months after their referral to FCU-O.
Eligibility Criteria
Inclusion Criteria: * Parents of toddler ages 22 month to 39 months who screen elevate on the Developmental Early Childhood Instrument for Deciding Effectively about Mental Health (DECIDE) tool risk calculator in a participating health center's pediatric practice Exclusion Criteria: * Unable to complete measures and consent process in English or Spanish
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07091240 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mental Health. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07091240 currently recruiting?
Yes, NCT07091240 is actively recruiting participants. Contact the research team at mhecenter@northwestern.edu for enrollment information.
Where is the NCT07091240 trial being conducted?
This trial is being conducted at Wilmington, United States.
Who is sponsoring the NCT07091240 clinical trial?
NCT07091240 is sponsored by Northwestern University. The trial plans to enroll 432 participants.