Behavioral Parent Training for Toddler Mental Health

(Peds-BRITE Trial)

Overseen By Scientific Project Director Peds-BRITE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Non-English/Spanish speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to support caregivers of toddlers likely to develop mental health challenges by offering a parenting program called Family Check-Up® Online (FCU-O). The program provides guidance to improve children's emotional and behavioral development. Caregivers can conveniently access this resource online and may choose to work with a coach or use it independently. The trial targets caregivers referred by their child's pediatrician based on a screening tool that identifies early signs of potential mental health issues. Participants will complete surveys and observational assessments before starting the program and again at six and twelve months. As an unphased trial, this study offers caregivers valuable resources that can positively impact their child's future well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Family Check-Up® Online (FCU-O) program is safe for toddler mental health?

Research has shown that the Family Check-Up Online (FCU-O) is safe for participants. This digital program aids in parenting and child development. Studies have found that FCU-O enhances parenting skills and boosts parents' confidence without any safety issues.

The program is user-friendly and accessible through a secure website at any convenient time. It is designed to meet the needs of different families. FCU-O has been implemented in various locations without causing any problems. As a support program rather than a medication, it avoids the risks associated with drugs.

Overall, studies confirm that using FCU-O is safe for supporting toddler mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Check-Up® Online (FCU-O) because it offers a fresh approach to supporting toddler mental health by empowering parents directly. Unlike traditional in-person parenting classes or therapy sessions, FCU-O is delivered online, allowing caregivers to access resources and guidance at their convenience. This digital platform provides personalized tools to help manage and improve children's emotional and behavioral development, making it more accessible and adaptable for busy families. Additionally, the use of the DECIDE tool for early screening helps identify at-risk children early on, potentially leading to timely interventions that can make a significant difference in a child's mental health trajectory.

What evidence suggests that the Family Check-Up® Online (FCU-O) program is effective for toddler mental health?

Research has shown that the Family Check-Up Online (FCU-O) program, used by participants in this trial, helps parents enhance their skills and boost their confidence. One study found that parents using FCU-O, particularly with coaching support, felt more capable and observed improvements in their child's emotional issues. Another study found that FCU-O reduced caregiver stress and encouraged parents to be more proactive and set limits. However, it did not directly impact the children's outcomes. Overall, the program appears promising for aiding parents in supporting their children's emotional and behavioral development. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for caregivers of toddlers who might be at risk for mental health issues. Caregivers will be referred to the program by their pediatrician based on a special screening tool used during well-check visits when the child is 24 or 30 months old.

Inclusion Criteria

My toddler is between 22 to 39 months old and has a high risk score for mental health issues.

Exclusion Criteria

Unable to complete measures and consent process in English or Spanish

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Caregivers participate in the Family Check-Up® Online (FCU-O) program, completing assessments related to their child's behavior and caregiving practices.

12 months

Online access at convenience

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6- and 12-month intervals.

12 months

Assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Family Check-Up® Online (FCU-O)

Trial Overview The study tests Family Check-Up® Online (FCU-O), a parenting support program delivered online, aimed at improving children's emotional and behavioral development. It includes tools and guidance, with optional coaching support.

How Is the Trial Designed?

Group I: Family Check-up Online (FCU-O) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0885200624001364

Family Check-Up Online effects on parenting and ... The current study demonstrates the effectiveness of the FCU-O intervention for improving parent-reported parenting skills, parenting self-efficacy, and ...

2. thefamilycheckup.com thefamilycheckup.com/sites/default/files/FCU%20and%20FCUO%20Overview.pdf

FCU and FCUO Overview.pdf The FCU Online with coaching support improved parents' self-efficacy and child emotional problems at three months post-test, with outcomes moderated by risk in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10018613/

Evaluating the Efficacy of the Family Check-Up Online to ... This study evaluated the effects of an enhanced version of the Family Check-Up Online (FCU-O), adapted to address parent and family functioning in response to ...

4. welcome.thefamilycheckup.com welcome.thefamilycheckup.com/resources

Resources This resource provides detailed information, reviews, data, links, and statistics about the Family Check-Up Model. Early Intervention Foundation Click above for ...

5. link.springer.com link.springer.com/article/10.1007/s11121-024-01725-3

Family Check-Up Online: Effects of a Virtual Randomized ... The FCU-O reduced caregiver stress and improved proactive parenting and limit setting but had no effects on youth outcomes.

6. welcome.thefamilycheckup.com welcome.thefamilycheckup.com/fcu-online

Online Program The Family Check-Up Online is a digital health program that was developed to be easily accessible, flexible and adaptable to the needs of families from ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07091240

Pediatricians Building Resilience Through Early ... FCU-O is a parenting support program that offers tools and guidance to support children's emotional and behavioral development. The program is ...

8. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2021.695967/full

The Family Check-Up Online: A Telehealth Model for ... In this article, we describe the FCU Online and review new content in the model that targets a population of young adult parents with substance abuse histories ...