NCT07091240

Pediatricians Building Resilience Through Early Identification for Toddler Well-Being

Innovative Risk Calculator and Telehealth Delivered Parenting Program for Mental Health Promotion in Pediatric Primary Care: A Hybrid Type 3 Effectiveness-Implementation Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 432 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mental Health

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2029-07-31
• Completion: 2030-01-31
• First posted: 2025-07-29
• Last updated: 2025-07-29

Locations

1 site across 1 country: United States