Pediatricians Building Resilience Through Early Identification for Toddler Well-Being

Part of paid clinical trials in Wilmington, Delaware.

Sponsor
Northwestern University
Study ID
NCT07091240
Status
Recruiting
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Conditions

  • Mental Health

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Behavioral Parent Training — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Jul 29, 2025
Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
432 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Family Check-up Online (FCU-O)
    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.

Primary Outcome Measure

Psychiatric Symptoms and Diagnosis [ Time Frame: 12 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nemours Children's HealthWilmingtonDelaware19803
Center Scientific Director Peds-BRITE
[email protected]
843-290-7288

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By research site
Nemours Children's Health· Wilmington, DE

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