Pediatricians Building Resilience Through Early Identification for Toddler Well-Being

NCT07091240 | Not Yet Recruiting DMC

• 2 other identifiers: P50MH122402-PBP50MH132502
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Psychiatric Symptoms and Diagnosis

  Parent interview to assess psychiatric disorders in preschool age children also known as the PAPA.

  12 month

Secondary Outcomes (8)

• Early Regulation and Context Assessment (ERICA)

  Baseline, 6- and 12 month

• Multidimensional Assessments Profile Scale (Temper Loss) (MAPS-TL)

  12-month

• Strengths and Difficulties Questionnaire (SDQ)

  Baseline, 6- and 12-month

• Early Childhood Irritability Related Impairment (E-CRI)

  12-month

• Early Childhood-Patient-Reported Outcomes Measurement Information System- Effortful Control (EC-PROMIS-EF)

  6- and 12-month

Study Arms (1)

Family Check-up Online (FCU-O)

EXPERIMENTAL

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 coa

Behavioral: Behavioral Parent Training

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.

Family Check-up Online (FCU-O)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to complete measures and consent process in English or Spanish

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Nemours Children's Health

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Scientific Project Director Peds-BRITE

CONTACT

843-290-7288; mhecenter@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 29, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): January 31, 2030
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)