Clinical trial NCT06876246: SBIR/ STTR Family Check-up Online
Official title: A Digital Health Technology to Prevent Family Violence and Improve Child Mental Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health
Parenting Stress
Academic Achievement
Parenting Skills
Behavior Problems
Keywords: digital health
implementation science
mental health
family intervention
school-based intervention
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-03-14
Enrollment: 1270
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 different school settings.

Detailed description: In this study the investigators propose the following specific aims:

1. Examine the feasibility and acceptability of embedding the FCU Online model into multi-tiered systems of support (MTSS). The investigative team (comprised of researchers and school partners) will (1a) identify strategies to reach students at risk for poor mental health outcomes using natural indicators within the school environment. Then, the team will (1b) identify feasible and acceptable implementation strategies for delivery of the basic (i.e., no coaching) and supported (i.e., with coaching) FCU Online models as routine school services. Phase 1 data suggest that schools vary in their preference for a coached vs. uncoached delivery system. The investigators will explore the best strategies for delivery of both models in a series of interviews with N=20 school providers and N=20 parents that will guide the Aim 2 effectiveness trial.
2. Conduct a comparative effectiveness trial to examine outcomes associated with the FCU Online model in school delivery systems. The investigators will examine the effectiveness of the FCU Online for middle school youth in a hybrid type 2 effectiveness-implementation trial. Based on Phase 1 results, 30 school providers across multiple districts will be randomly assigned to deliver the basic (i.e., no coaching) or supported (i.e., with coaching) digital health model. Each provider will enroll 20 families/students (N=600) in the intervention across one year. The investigators will test parent and student outcomes associated with the program over a 6-month period including student mental health and behavior problems. Potential moderators of family engagement and improved outcomes, including pre-existing risk (family and student level) and provider characteristics, will be examined. The investigators hypothesize greater effects of The FCU Online with coaching for students with high baseline behavior problems and for providers with experience working with high-risk students. Moderation analysis results will highlight which students might benefit most from the FCU Online with coaching and from which providers.
3. Examine factors related to successful implementation in schools that will guide future commercialization. Guided by the RE-AIM implementation framework, the investigators will evaluate factors related to Reach (percent of students who received FCU Online supports), Adoption (who engages at schools and to what extent), Implementation (fidelity monitoring and usage),and Maintenance (provider usage at end of clinical trial) of the FCU Online models. These analyses will inform commercialization and funding models for the product in school delivery systems and future plans for Phase III funding.

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.

Primary outcomes:
measure: Change from Baseline in Child Depression (Parent report)
timeFrame: baseline, 6 months
measure: Change from Baseline in Child Anxiety (Parent report)
timeFrame: baseline, 6 months
measure: Change from Baseline in Positive Parenting (Parent report)
timeFrame: baseline, 6 months
measure: Change from Baseline in Rules and Consequences (Parent report)
timeFrame: baseline, 6 months
measure: Change from Baseline in Positive Communication (Parent report)
timeFrame: baseline, 6 months
measure: Change from Baseline in Supporting School Success (Parent report)
timeFrame: baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Prevention Science Institute
state: Oregon
Study officials:
affiliation: University of Oregon
name: Anne M Mauricio, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwest Prevention Science
name: Lisa A Reiter, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwest Prevention Science
name: Elizabeth A Stormshak, PhD
role: PRINCIPAL_INVESTIGATOR
References: