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NCT06876246From ClinicalTrials.govRecruiting

SBIR/ STTR Family Check-up Online

A Digital Health Technology to Prevent Family Violence and Improve Child Mental Health

  • Mental Health
  • Parenting Stress
  • Academic Achievement
  • Parenting Skills
  • Behavior Problems

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
University of Oregon
Enrolment target
670
Started
20 January 2025
Main results due
30 June 2027
Study sites
1
Registry updated
29 September 2026

Can you take part?

  • No age limit is stated.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • Prevention Science Institute

    Eugene, Oregon, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06876246. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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SBIR/ STTR Family Check-up Online | Trialion