Pediatricians Building Resilience Through Early Identification for Toddler Well-Being

NANot yet recruitingINTERVENTIONAL
Enrollment

432

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

July 31, 2029

Study Completion Date

January 31, 2030

Conditions
Mental Health
Interventions
BEHAVIORAL

Behavioral Parent Training

Family Check-Up® Online 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.

Trial Locations (1)

19803

Nemours Children's Health, Wilmington

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Northwestern University

OTHER

NCT07091240 - Pediatricians Building Resilience Through Early Identification for Toddler Well-Being | Biotech Hunter | Biotech Hunter