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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the proposed research is to conduct an efficacy trial of the Family Check-Up (FCU) Online to prevent emotional and behavioral disorders among middle-school students at-risk for disability during the transition back to school after the COVID-19 pandemic. Mental health and behavior problems are at epidemic proportions as a result of the COVID-19 pandemic, with the highest rates in adolescents and children with disabilities. We propose to evaluate the efficacy of the FCU Online, a school-based, ecological approach to family intervention and risk reduction, across a group of students at-risk or identified with disability during the middle school years. The FCU Online for middle school youth has been evaluated in a randomized trial in prior research during the development of the program but has never been tested as a large-scale, school-based intervention or delivered by providers working in schools. It has recently been adapted for COVID-19 and includes new modules on coping with stress and home-to-school engagement to support the return to school after COVID-19 for students at-risk. Students in schools will be identified for services using indicators that are natural to the school environment (attendance, office discipline referrals, and grades), and will be followed for 2 years. We predict that engagement in the FCU Online will be associated with student reductions in emotional and behavior problems, improvements in academic skills, and improvements in attendance. Parenting skills such as home-to-school communication, positive parenting, and behavioral routines will be tested as mediators of intervention efficacy.

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 data supports the effectiveness of the treatment Family Check-Up for disruptive behaviors?

Research shows that the Family Check-Up treatment can significantly reduce disruptive behaviors in children, improve family functioning, and increase positive parenting practices. It has been particularly effective for children at risk of persistent conduct problems, with benefits observed in both child behavior and parental involvement. ^{1 2 3 4 5}

Is the Family Check-Up intervention safe for humans?

The Family Check-Up intervention has been studied in various settings and has shown positive effects on parenting and child behavior without any reported safety concerns. It is a family-based approach that focuses on improving family dynamics and reducing child conduct problems. ^{1 3 5 6 7}

How is the Family Check-Up treatment different from other treatments for disruptive behaviors?

The Family Check-Up is unique because it is a family-based intervention that focuses on motivating change and tailoring the approach to each family's needs. It emphasizes improving parent-child interactions and addressing risk factors early, which can prevent the worsening of disruptive behaviors in children. ^{1 3 5 7 8}

Research Team

Elizabeth Stormshak, Ph.D.

Principal Investigator

University of Oregon

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

The Family Check-Up in early childhood: a case study of intervention process and change. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Indirect effects of fidelity to the family check-up on changes in parenting and early childhood problem behaviors. [2023]

3. United States 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Families Who Benefit and Families Who Do Not: Integrating Person- and Variable-Centered Analyses of Parenting Intervention Responses. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of a family-centered approach to the prevention of early conduct problems: 2-year effects of the family check-up in early childhood. [2019]

6. United States 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

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

8. Canada pubmed.ncbi.nlm.nih.gov

Behavior problems in children: a family approach to assessment and management. [2021]