SBIR/ STTR Family Check-up Online

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Oregon

About 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.

Eligibility criteria

Qualifiers

A caregiver must have a child between the ages of 11 and 14 enrolled at a participating school;

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; and

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

Disqualifiers

the caregiver is unable to read in either English or Spanish; or

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

Trial design

Treatments tested in this trial

  • Family Check-Up Online
  • FCU Online with Telehealth Coaching

Treatment groups

1,270 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Oregon

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator