SBIR/ STTR Family Check-up Online

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-20

Study Completion Date

2027-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mental Health Parenting Stress Academic Achievement Parenting Skills Behavior Problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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FCU Online with telehealth coaching

FCU Online Digital intervention with telehealth coaching. This arm includes usage of the digital intervention plus telehealth support from a parenting coach.

Group Type EXPERIMENTAL

FCU Online with Telehealth Coaching

Intervention Type BEHAVIORAL

This intervention is the Family Check-Up Online plus telehealth support from a parenting coach. The Family Check-Up Online is a digital intervention that includes an assessment, computer-generated feedback, and intervention modules that focus on improving family relationships and parenting skills in order to reduce child mental health problems and to improve child self-regulation. These modules include Healthy Behaviors for Stressful Times, Positive Parenting, Rules and Consequences, Supporting School Success, and Communication. A coach based at the child's school meets with caregivers via telehealth modality to provide motivation and to help caregivers tailor the content of the modules to their specific child and family's needs.

FCU Online

FCU Online digital intervention. This arm includes use of the digital intervention only (i.e., no telehealth coaching).

Group Type EXPERIMENTAL

Family Check-Up Online

Intervention Type BEHAVIORAL

The Family Check-Up Online is a digital intervention that includes an assessment, computer-generated feedback, and intervention modules that focus on improving family relationships and parenting skills in order to reduce child mental health problems and to improve child self-regulation. These modules include Healthy Behaviors for Stressful Times, Positive Parenting, Rules and Consequences, Supporting School Success, and Communication.

Providers participating in feasibility/ acceptability interviews

School-based providers will be interviewed to help the research team identify feasible and acceptable implementation strategies for delivery of the basic and supported FCU Online models as routine school services.

Group Type NO_INTERVENTION

No interventions assigned to this group

Parents participating in feasibility/ acceptability interviews

Parents of middle school-aged students will be interviewed to help the research team identify feasible and acceptable implementation strategies for delivery of the basic and supported FCU Online models as routine school services.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Family Check-Up Online

The Family Check-Up Online is a digital intervention that includes an assessment, computer-generated feedback, and intervention modules that focus on improving family relationships and parenting skills in order to reduce child mental health problems and to improve child self-regulation. These modules include Healthy Behaviors for Stressful Times, Positive Parenting, Rules and Consequences, Supporting School Success, and Communication.

Intervention Type BEHAVIORAL

FCU Online with Telehealth Coaching

This intervention is the Family Check-Up Online plus telehealth support from a parenting coach. The Family Check-Up Online is a digital intervention that includes an assessment, computer-generated feedback, and intervention modules that focus on improving family relationships and parenting skills in order to reduce child mental health problems and to improve child self-regulation. These modules include Healthy Behaviors for Stressful Times, Positive Parenting, Rules and Consequences, Supporting School Success, and Communication. A coach based at the child's school meets with caregivers via telehealth modality to provide motivation and to help caregivers tailor the content of the modules to their specific child and family's needs.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes