Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment432 (estimated)
SponsorNorthwestern University
Academic / other
Locations1 site (Wilmington, Delaware)
StatusRecruiting
StartedJune 1, 2026
Main results expectedJuly 31, 2029
Study endsJanuary 31, 2030
Registry record updatedJuly 8, 2026
Trial IDNCT07091240 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.