Family Check-Up Online for Child Mental Health

Overseen By Anne M Mauricio, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Oregon

Disqualifiers: Non-English/Spanish reader, Other study

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

Compensation: Varies

Number of Visits: 20

1270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program called Family Check-Up Online, designed to improve child mental health by involving families. Families will use either a digital tool alone or with added telehealth coaching to determine which method better supports children's mental health and behavior. Parents of middle schoolers needing extra support at school may be suitable for this trial if they have a smartphone and email access. The goal is to integrate this program into regular school services, fostering collaboration between families and schools for improved mental health outcomes. As an unphased trial, participants contribute to innovative research that may enhance school-based mental health support.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Family Check-Up Online is safe for child mental health?

Research has shown that the Family Check-Up Online (FCU-O) has been tested in several studies. These studies found that it improves parenting and reduces caregiver stress, although it did not significantly change children's outcomes. The FCU-O is an online tool designed to help families enhance children's mental health and behavior, and it has been used successfully in various settings.

The version with telehealth coaching provides parents with additional support. This coaching can help tailor strategies to each family's needs. Studies also show that this version reduces caregiver stress and enhances parenting skills.

Overall, the Family Check-Up Online, with or without coaching, is considered safe and well-tolerated. No reports of serious side effects have emerged. This suggests that both versions are safe options for families aiming to improve family relationships and support children's mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Check-Up Online treatment for child mental health because it offers a unique digital approach to supporting families. Unlike traditional therapy or in-person counseling, this treatment provides an online platform where parents can receive guidance and support at their convenience. One arm of the treatment even includes telehealth coaching from a parenting expert, combining digital accessibility with personalized advice. This approach could make mental health support more accessible and flexible for families, potentially leading to better outcomes for children struggling with mental health issues.

What evidence suggests that the Family Check-Up Online is effective for improving child mental health?

Research shows that the Family Check-Up Online program improves parenting skills and child behavior. Studies have found that the program reduces caregiver stress and encourages proactive parenting. For children, evidence indicates better emotional well-being and fewer behavior problems. In this trial, participants may receive the version with telehealth coaching, which effectively boosts parents' confidence and addresses children's emotional issues. Overall, over 20 years of research back the program, proving its success in enhancing family relationships and children's mental health. ^{2 4 6 7 8}

Who Is on the Research Team?

Lisa A Reiter, PhD

Principal Investigator

Northwest Prevention Science

Anne M Mauricio, PhD

Principal Investigator

University of Oregon

Elizabeth A Stormshak, PhD

Principal Investigator

Northwest Prevention Science

Are You a Good Fit for This Trial?

This trial is for caregivers with a child aged 11-14 who needs extra support at school. Caregivers must be able to read English or Spanish, have a smartphone with texting and email access, and not be in another University of Oregon study.

Inclusion Criteria

The caregiver must be the parent or legal guardian of the youth

The caregiver must have a smartphone with text messaging capability and access to email

The youth must be identified by school providers as needing or being eligible for Tier 2 or Tier 3 supports or services

Exclusion Criteria

The caregiver is unable to read in either English or Spanish

The family is already participating in another study of the University of Oregon's Prevention Science Institute.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility and Acceptability Assessment

Examine the feasibility and acceptability of embedding the FCU Online model into multi-tiered systems of support (MTSS) and identify implementation strategies.

6 months

Interviews with 20 school providers and 20 parents

Effectiveness Trial

Conduct a comparative effectiveness trial to examine outcomes associated with the FCU Online model in school delivery systems.

6 months

Ongoing monitoring and data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Family Check-Up Online

Trial Overview The trial tests the Family Check-Up Online program, both uncoached and with telehealth coaching, to improve family relationships, parenting skills, and children's mental health. Providers will use it in schools to see how well it works in real-world settings.

How Is the Trial Designed?

Group I: FCU Online with telehealth coaching Experimental Treatment 1 Intervention

FCU Online Digital intervention with telehealth coaching. This arm includes usage of the digital intervention plus telehealth support from a parenting coach.

Group II: FCU Online Experimental Treatment 1 Intervention

FCU Online digital intervention. This arm includes use of the digital intervention only (i.e., no telehealth coaching).

Group III: Providers participating in feasibility/ acceptability interviews Active Control 1 Intervention

School-based providers will be interviewed to help the research team identify feasible and acceptable implementation strategies for delivery of the basic and supported FCU Online models as routine school services.

Group IV: Parents participating in feasibility/ acceptability interviews Active Control 1 Intervention

Parents of middle school-aged students will be interviewed to help the research team identify feasible and acceptable implementation strategies for delivery of the basic and supported FCU Online models as routine school services.

Who Is Running the Clinical Trial?

University of Oregon

Lead Sponsor

Trials

91

Recruited

46,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

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

Online Program The online program's flexibility allows for personalized intervention plans, addressing specific issues related to improving family communication and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10077819/

Evaluating the Efficacy of the Family Check-Up Online Results from other RCTs that examined the efficacy of the TPOL-Brief have demonstrated significant improvements in parenting and child behavior outcomes, ...

3. welcome.thefamilycheckup.com welcome.thefamilycheckup.com/sites/default/files/2025-09/FCU-Online-Overview.pdf

FCU® Online Overview 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 ...

4. 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 ...

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/resources

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

7. 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 ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/99/NCT05117099/ICF_001.pdf

Long-term effects of the Family Check-Up on Depression ... The purpose of this research is to test the effectiveness of a web-based parenting curriculum (the Family Check-Up Online) to strengthen family functioning and ...