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SBIR/ STTR Family Check-up Online

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Aug 31, 2026 → Jun 30, 2027
Enrollment reduced 47% 1270 → 670 participants
See other at-risk trials from University of Oregon

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 31, 2026 to Jun 30, 2027
    • Enrollment reduced: 1270 → 670 participants
    • Eligibility criteria expanded, about 6 words
    • Study description expanded, about 3 words
  2. Primary completion moved earlier from Dec 31, 2026 to Aug 31, 2026
    • Study completion moved earlier from Dec 31, 2027 to Aug 31, 2027
    v4
  3. Primary completion date: Aug 31, 2026 to Dec 31, 2026
    • Study completion date: Aug 31, 2027 to Dec 31, 2027
    v3
  4. Eligibility criteria expanded, about 5 wordsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06876246
Lead Sponsor University of Oregon
Collaborators: National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 Mental Health, Parenting Stress, Academic Achievement, Parenting Skills, Behavior Problems
Related terms Mental Disorders, Psychological Well-Being
Enrollment 670 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov