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

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

Compensation: Varies

Number of Visits: 20

1270 Participants Needed

Trial Summary

What is the purpose of this trial?

The Family Check-Up Online, a digital health intervention, was designed to improve child mental health through family-centered intervention. The Family Check-Up is grounded in over 25 years of evidence-based research and has been shown to improve child mental health and behavior including depression and conduct problems. The investigators were supported by an SBIR Phase I award (R43MH132191) to evaluate the feasibility and acceptability of the digital health product in schools and to adapt the product based on findings of that work. Findings from that project suggested the model is a good fit for schools, with school providers stating a need for family-centered interventions that target child behavior and mental health, but with few resources or evidence-based programs available. The research team received feedback that suggests the model should be evaluated as both an uncoached version and coached version, delivered with provider support. In the current project, the investigators plan to continue work in schools to develop the model for commercialization, including understanding the process for embedding the FCU Online into current student support systems and implementation factors that lead to maintenance of the model in schools. The investigators plan to conduct a hybrid type 2 effectiveness-implementation trial to evaluate the effectiveness of the FCU Online when delivered by real world providers. Thirty providers (N=600 students/families) will be randomly assigned to receive training in the FCU Online coached vs. uncoached models. The research team will then evaluate outcomes including family relationships, parenting skills, and child mental health and behavior. The investigators predict that the FCU Online will improve child mental health and behavior, and will test for moderators such as provider training and child baseline risk. Findings will have implications for commercialization of the product in schools and implementation of the model in a range of different school settings.

Research Team

Anne M Mauricio, PhD

Principal Investigator

University of Oregon

Lisa A Reiter, PhD

Principal Investigator

Northwest Prevention Science

Elizabeth A Stormshak, PhD

Principal Investigator

Northwest Prevention Science

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+