Mental HealthPeds-BRITENCT07091240
Pediatricians Building Resilience Through Early Identification for Toddler Well-Being
A study testing Behavioral Parent Training in people with Mental Health, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- Behavioral Parent Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to complete measures and consent process in English or Spanish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nemours Children's Health
Wilmington, Delaware, 19803
Center Scientific Director Peds-BRITE, 843-290-7288, mhecenter@northwestern.edu
About this study
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
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
- Being tested
- Behavioral Parent Training
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Parent TrainingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Family Check-up Online (FCU-O) | Experimental | 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. Receives: Behavioral: Behavioral Parent Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric Symptoms and Diagnosis
Parent interview to assess psychiatric disorders in preschool age children also known as the PAPA.
Measured: 12 month
Secondary outcomes (8)
Early Regulation and Context Assessment (ERICA)
ERICA stands for early regulation and context assessment which is a direct assessment of child regulation skills.
Measured: Baseline, 6- and 12 month
Multidimensional Assessments Profile Scale (Temper Loss) (MAPS-TL)
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.
Measured: 12-month
Strengths and Difficulties Questionnaire (SDQ)
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.
Measured: Baseline, 6- and 12-month
Early Childhood-Patient-Reported Outcomes Measurement Information System- Effortful Control (EC-PROMIS-EF)
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).
Measured: 6- and 12-month
Parenting Young Children (PARYC)
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.
Measured: Baseline, 6-, 12 month
Minnesota Executive Function Scale (MEFS)
Direct assessment of executive functioning that is completed by children on an internet browser i.e., children complete a card sorting task.
Measured: Baseline, 6- and 12-months
Multidimensional assessment profiles- Early Assessment Screening for Irritability (MAPS-EASI) Impairment Plus
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.
Measured: Baseline 6- and 12 months
Child and Parent Relationship Scale (CPRS)
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.
Measured: Baseline, 6-, and 12-month assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Jun 2026
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Justin D. Smith, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091240
- Sponsor's protocol ID
- P50MH122402-PB
- Other IDs
- P50MH132502
- Acronym
- Peds-BRITE
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07091240
- Acronym / sponsor ID
- Peds-BRITE / P50MH122402-PB
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family Check-up Online (FCU-O) | Experimental | Behavioral: Behavioral Parent TrainingCaregivers 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to complete measures and consent process in English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Parent TrainingFamily 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. | Behavioural | Family Check-up Online (FCU-O) |
Primary outcome
Psychiatric Symptoms and Diagnosis
Time frame: 12 month
Parent interview to assess psychiatric disorders in preschool age children also known as the PAPA.
8 secondary outcomes
Early Regulation and Context Assessment (ERICA)
Time frame: Baseline, 6- and 12 month
Multidimensional Assessments Profile Scale (Temper Loss) (MAPS-TL)
Time frame: 12-month
Strengths and Difficulties Questionnaire (SDQ)
Time frame: Baseline, 6- and 12-month
Early Childhood-Patient-Reported Outcomes Measurement Information System- Effortful Control (EC-PROMIS-EF)
Time frame: 6- and 12-month
Parenting Young Children (PARYC)
Time frame: Baseline, 6-, 12 month
Minnesota Executive Function Scale (MEFS)
Time frame: Baseline, 6- and 12-months
Multidimensional assessment profiles- Early Assessment Screening for Irritability (MAPS-EASI) Impairment Plus
Time frame: Baseline 6- and 12 months
Child and Parent Relationship Scale (CPRS)
Time frame: Baseline, 6-, and 12-month assessments
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Parent Training in people with Mental Health, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scientific Project Director Peds-BRITE (843-290-7288, mhecenter@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychiatric Symptoms and Diagnosis (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.