Family Check-Up for Disruptive Behaviors

(FMSS Trial)

Overseen By Allison Caruthers, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Oregon

Disqualifiers: Non-English/Spanish reader, Survey assistance, Other study

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

Compensation: Varies

Number of Visits: Unknown

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 (FCU) to prevent emotional and behavioral issues in middle-school students. The program targets students at risk of problems such as poor grades, frequent absences, or behavioral issues, especially those returning to school after the COVID-19 pandemic. Parents will gain access to an FCU app and receive support from a mental health coach to enhance parenting skills and better support their children. This trial may suit middle-schoolers facing challenges like frequent discipline referrals or low grades. As an unphased trial, it offers a unique opportunity to access innovative support tools for children's well-being.

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 middle-school students?

Research shows that the Family Check-Up Online (FCU Online) is safe and easy to use. Past studies have demonstrated that this program improves family relationships and children's mental health without causing major problems. As a web-based tool, it is easily accessible from home and offers resources and coaching to help parents with skills like communication and setting rules.

Parents who used the app reported better family interactions and fewer behavior issues in their children. The additional telehealth coaching supports healthy habits and positive parenting. Since FCU Online focuses on family support and parenting, it does not involve medications or physical procedures, reducing risks compared to drug trials. Overall, the app and coaching serve as a helpful resource, making it a safe choice for families aiming to enhance their home environment and children's well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Check-Up (FCU) treatment for disruptive behaviors because it leverages technology to provide personalized support to parents. Unlike traditional methods that might involve in-person therapy sessions, FCU offers an online app paired with telehealth coaching, making it more accessible and convenient for families. The app includes a quick assessment and delivers tailored feedback, along with interactive tools like videos and parenting tips to help parents improve their skills. This approach not only makes support more readily available but also empowers parents with resources to address challenges in real-time, potentially leading to more effective outcomes.

What evidence suggests that the Family Check-Up is effective for preventing disruptive behaviors?

Research shows that the Family Check-Up (FCU) Online program helps reduce disruptive behavior in children. In this trial, some participants will receive the FCU Online program with telehealth coaching. Studies also find that it improves parenting skills, leading to better behavior in children. These improvements include more positive interactions between parents and children and greater parental involvement in their child's life. Additionally, online parenting programs like FCU have effectively reduced child behavior problems. Overall, the FCU Online approach has shown promise in supporting families, especially during challenging times like returning to school after the COVID-19 pandemic. ^{1 5 6 7 8}

Who Is on the Research Team?

Elizabeth Stormshak, Ph.D.

Principal Investigator

University of Oregon

Are You a Good Fit for This Trial?

This trial is for middle school students aged 11-14 at Alder Creek or Wilbur Rowe Middle Schools in Milwaukee, Oregon, who show signs of emotional and behavioral issues. Eligible students have poor grades (below a 2.5 GPA), frequent absences, multiple discipline referrals, an IEP for emotional disturbance, or concerning mental health screener scores. Caregivers must have a smartphone with text and email access.

Inclusion Criteria

The student must have one or more of the following risk factors: 1) two or more office discipline referrals; 2) grades below a 2.5 GPA; 3) poor attendance, i.e., missing more than 10% of school days; 4) IEP for emotional disturbance or related disabilities; or 5) concerns about the child on the behavioral and mental health screener (as indicated by a score of 3 on any one item, or a score of 2 or higher on at least two items)

I am a caregiver of a child aged 11 to 14.

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

Exclusion Criteria

My child needs my help to complete surveys.

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

The caregiver is unable to read in either English or Spanish

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Family Check-Up (FCU) Online intervention, including access to the FCU app and telehealth coaching/support provided by a trained mental health provider.

24 months

Regular virtual sessions

Follow-up

Participants are monitored for changes in emotional and behavioral problems, academic competence, and other outcomes.

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Family Check-Up

Trial Overview The Family Check-Up Online program is being tested to see if it can help reduce behavior and emotional problems in middle-schoolers at risk after COVID-19 disruptions. It's delivered through schools and includes modules on stress coping and improving home-to-school engagement.

How Is the Trial Designed?

Group I: FCU Online + Coach Experimental Treatment 1 Intervention

Parents in this arm will receive access to the FCU app and telehealth coaching/ support provided by a trained mental health provider. The FCU app includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include videos, animated videos, parenting tips, and interactives to help practice parenting skills. Telehealth coaching sessions will focus on Healthy Behaviors, Positive Parenting, Rules and Consequences, School Support, and Communication.

Group II: Control Active Control 1 Intervention

Parents in this arm will receive school support as usual.

Who Is Running the Clinical Trial?

University of Oregon

Lead Sponsor

Trials

91

Recruited

46,700+

Published Research Related to This Trial

The Family Check-Up (FCU) intervention model has been shown to effectively enhance family management skills and reduce risk behaviors in at-risk children and families over 20 years of research.

Implementing the FCU in schools has been linked to a significant reduction in the long-term risk of substance use during adolescence, highlighting its potential as a valuable public health strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based, family-centered intervention to prevent substance use: the family check-up. Stormshak, EA., Dishion, TJ.[2021]

The Family Check-Up (FCU) intervention demonstrated clinically meaningful improvements in both child behavior and family functioning over a 2-year period, even in the presence of various risk factors.

This case study supports findings from a larger multisite randomized control trial, suggesting that the FCU can be effectively applied to diverse populations at risk for problem behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Family Check-Up in early childhood: a case study of intervention process and change. Gill, AM., Hyde, LW., Shaw, DS., et al.[2019]

The Family Check-Up 4 Health (FCU4Health) program, tested on 240 pediatric patients with elevated BMI, showed significant improvements in parenting skills and child behavioral health within 6 months compared to usual care.

Improvements in parenting were linked to better child self-regulation, which subsequently led to reductions in conduct and emotional problems, indicating a positive chain reaction from the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Family Check-Up 4 Health on Parenting and Child Behavioral Health: A Randomized Clinical Trial in Primary Care. Berkel, C., Fu, E., Carroll, AJ., et al.[2021]

The Family Check-Up (FCU) intervention significantly reduces conduct problems in children, especially for those whose parents reported high levels of conduct problems at the start of the study, involving 731 mother-child dyads followed from ages 2 to 9.5.

The FCU not only decreased conduct problems but also improved positive interactions between parents and children, demonstrating its effectiveness in enhancing family dynamics regardless of the initial level of conduct problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Family Check-Up on reducing growth in conduct problems from toddlerhood through school age: An analysis of moderated mediation. Shelleby, EC., Shaw, DS., Dishion, TJ., et al.[2020]

Citations

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

Evaluating the Efficacy of the Family Check-Up Online In a meta-analysis of digital-based parent training for parents of children with disruptive behaviors, researchers found positive improvements in outcomes of ...

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

Family Check-Up Online effects on parenting and ... Overall, online parenting interventions have been found to be effective in reducing child behavior problems and improving parenting skills, with comparable ...

3. cebc4cw.org cebc4cw.org/program/family-check-up/detailed

CEBC » Family Check Up › Program › Detailed Results indicate that FCU was associated with reductions in disruptive behavior and greater maternal involvement and was particularly effective for children ...

4. 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 ...

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

FCU and FCUO Overview.pdf The Family. Check-Up involves assessment, feedback, and intervention support for families with the goal of increasing parenting skills and family relationships.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8294463/

The Family Check-Up Online: A Telehealth Model for ... An evidence-based program for reducing risk behavior, enhancing parenting skills, and preventing the onset of substance use.

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

Online Program The Family Check-Up Online is a digital program with five modules, an online assessment, and tailored feedback, covering topics like communication and behavior ...

8. welcome.thefamilycheckup.com welcome.thefamilycheckup.com/

The Family Check-Up: Home The Family Check-Up Online is a web-based app that improves family relationships and reduces child mental health concerns. It can be used independently.