Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07091240

Pediatricians Building Resilience Through Early Identification for Toddler Well-Being

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Children's Health

Wilmington, Delaware, 19803, United States

Location status: Recruiting

Location contact

Center Scientific Director Peds-BRITE

CONTACT

[email protected]

843-290-7288

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Psychiatric Symptoms and Diagnosis

    Time frame: 12 month

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

Secondary outcomes

  1. Early Regulation and Context Assessment (ERICA)

    Time frame: Baseline, 6- and 12 month

    ERICA stands for early regulation and context assessment which is a direct assessment of child regulation skills.

  2. Multidimensional Assessments Profile Scale (Temper Loss) (MAPS-TL)

    Time frame: 12-month

    This is a survey of child temper loss and irritability. Parents report on children's behavior on a scale of children's irritable behaviors on a scale from zero (never) to five (many times each day). They also report on the impact of child irritability on a scale from zero (no problems) to three (severe problems). Scores are summed and higher scores indicate more irritability behaviors.

  3. Strengths and Difficulties Questionnaire (SDQ)

    Time frame: Baseline, 6- and 12-month

    The SDQ is a brief child behavior screening questionnaire. Parents report on children's strengths and difficulties on a three point scale (not true, somewhat true and certainly true). They also report on the impact of these strengths and difficulties on a four point scale which varies (e.g., no/yes with minor difficulties, definite difficulties/severe difficulties; not at all, only a little, a medium amount, a great deal). The total difficulties score is on a scale of 0 to 40 with higher scores indicating more difficulties. Then the internalizing and externalizing scores range from zero to twenty with higher scores indicating more emotional and peer difficulties. The impact score ranges from zero to 10 with higher scores indicating greater impact on daily life.

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

    Time frame: 6- and 12-month

    Parent reported measure of children's effortful control. There are six parent report items on child's frustration tolerance and flexibility each item is on a five point scale from never (meaning no frustration tolerance and flexibility) to always (e.g., always flexible).

  5. Parenting Young Children (PARYC)

    Time frame: Baseline, 6-, 12 month

    Parenting Young Children (PARYC): Proactive Parenting: The PARYC (Proactive Parenting Subscale) includes 7 questions related to parenting behaviors that are supportive of children's early mental health and development. The survey takes less than 5 minutes to complete.

  6. Minnesota Executive Function Scale (MEFS)

    Time frame: Baseline, 6- and 12-months

    Direct assessment of executive functioning that is completed by children on an internet browser i.e., children complete a card sorting task.

  7. Multidimensional assessment profiles- Early Assessment Screening for Irritability (MAPS-EASI) Impairment Plus

    Time frame: Baseline 6- and 12 months

    The MAPS-EASI is a shortened version MAPS-TL designed for clinical screening. Parents report on children's irritable behaviors on a scale of zero (never) to five (many times each day). They also report on the impact of irritability on a scale from zero (no problems) to three (severe problems). Scores are summed and higher scores indicate more irritability behaviors. There is a maximum score of 15 for irritable behaviors and there is a maximum score of 6 on impact. The impairment items ask about how irritability affects families' lives and the plus items ask about how they affect children in varying contexts.

  8. Child and Parent Relationship Scale (CPRS)

    Time frame: Baseline, 6-, and 12-month assessments

    Child and Parent Relationship Scale (CPRS): The CPRS includes 7 questions about the closeness of the parent-child relationship. It takes less than 5 minutes to complete.

Study contacts

Contact information is provided by the study sponsor or research team.

Scientific Project Director Peds-BRITE

CONTACT

[email protected]

843-290-7288

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: Peds-BRITE

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 29, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.