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NCT06876246 · ClinicalTrials.gov registry record · NA
SBIR/ STTR Family Check-up Online
A NA study of Mental Health and Parenting Stress, sponsored by University of Oregon.
- Recruiting
- Registry status
- NA
- Development phase
- 1,270
- Enrollment target
- 1
- Study location
NCT06876246: Recruiting NA study of Mental Health and Parenting Stress, sponsored by University of Oregon.
NCT06876246 is a NA study of Mental Health and Parenting Stress that is actively recruiting participants, run by University of Oregon. The registered enrollment target is 1,270 participants, below the 10,163-participant average among 62 other Mental Health trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06876246, a NA study of Mental Health and Parenting Stress, is actively recruiting participants, sponsored by University of Oregon.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,270 participants
- Enrollment target
- 1
- Study location
Study Summary
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 diffe
Primary Outcome
Parents report on their child's depression using the two item PHQ-2. Scores for the individual items range from 0 (not at all) to 3 (nearly all) and are summed together. Higher scores indicate greater child depression.
Conditions Studied
Interventions
- BEHAVIORAL Family Check-Up Online
- BEHAVIORAL FCU Online with Telehealth Coaching
Study Locations (1)
Oregon
- Prevention Science Institute - Eugene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,270 participants |
| Start Date | 2025-01-20 |
| Est. Completion | 2027-08-31 |
| Phase | NA |
What NCT06876246 shows while recruiting
NCT06876246 is an interventional study that assigns participants to a tested intervention. Its 1,270 participants enrollment target places it among the larger protocols in the corpus, below the 10,163-participant average among 62 other Mental Health trials with a reported enrollment target (88% lower).
The record links to 5 conditions, with Mental Health appearing as the primary indexed condition, and to 2 interventions - of which Family Check-Up Online is the first listed.
NCT06876246 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT06876246 about?
NCT06876246 is a clinical study titled "SBIR/ STTR Family Check-up Online". 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...
What is the current status of trial NCT06876246?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,270 participants. The study started on 2025-01-20. Estimated completion is 2027-08-31.
What conditions does trial NCT06876246 study?
This clinical trial studies the following conditions: Mental Health, Parenting Stress, Behavior Problems, Academic Achievement, Parenting Skills.
What interventions are being tested in trial NCT06876246?
The interventions under investigation include: Family Check-Up Online (BEHAVIORAL), FCU Online with Telehealth Coaching (BEHAVIORAL).
Who is sponsoring clinical trial NCT06876246?
This trial is sponsored by University of Oregon, which has 63 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06876246 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06876246's enrollment target sits among peer trials
1,270 10th of 62 higher than 53 of 62 other Mental Health trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mental Health trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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