Pediatricians Building Resilience by Early Identification for Toddler Well-Being
Official title: Innovative Risk Calculator and Telehealth Delivered Parenting Program for Mental Health Promotion in Pediatric Primary Care: A Hybrid Type 3 Effectiveness-Implementation Study
Run by Northwestern University · NCT07091240 · Data updated 2026-11-12
This program tests a parenting support online tool (FCU-O) for caregivers of toddlers at risk of mental health challenges to see if it helps improve child behavior and caregiving practices.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 432 (estimated) |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Wilmington, Delaware) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | July 31, 2029 |
| Study ends | January 31, 2030 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT07091240 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are parents of 22- to 39-month-old children who screen elevated risk on the DECIDE tool in participating pediatric practices and are able to complete measures in English or Spanish.
✕Probably not a fit
Caregivers whose children do not screen elevated risk or who cannot engage with the online program may see no direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
caregivers of 22 to 39 month olds who screen elevated on a risk tool will access Family Check-Up Online (FCU-O) through a secure site and complete behavior and caregiving assessments. Clinicians use the DECIDE risk score at well-check visits to refer families to FCU-O, which can be used with or without a trained coach. The intervention focuses on behavioral parent training delivered online and tailored to families in participating pediatric practices. The trial uses routine pediatric visits and online resources to support early mental health prevention. The study is led by Northwestern University with NIMH collaboration and is conducted at Nemours Children's Health in Wilmington, DE.
Why it matters
Potential benefit: If successful, caregivers may gain practical skills and resources to support their toddlers' emotional and behavioral development, potentially reducing later mental health challenges.
How similar studies have gone: Prior behavioral parent training programs delivered online have shown improvements in parenting practices and child behavior in similar populations, though this exact DECIDE/FCU-O integration is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Nemours Children's Health
Wilmington, Delaware, United States Recruiting
Study contacts
- Study coordinator: Scientific Project Director Peds-BRITE
- Email: mhecenter@northwestern.edu
- Phone: 843-290-7288
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.