Recruiting

Observational Study

Sponsor:

University of Oregon

Code:

NCT06876246

Conditions

Mental Health

Parenting Stress

Academic Achievement

Parenting Skills

Behavior Problems

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Family Check-Up Online

FCU Online with Telehealth Coaching

Study Details

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.

Conditions

Mental Health

Parenting Stress

Academic Achievement

Parenting Skills

Behavior Problems

Study ID

NCT06876246

Start date

Jan 20, 2025

Status verified date

Jul, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: FCU Online

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

no intervention: 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.

no intervention: 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.

Interventions

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.

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.

Primary outcome measure

  • Change from Baseline in Child Depression (Parent report) [ Time Frame: baseline, 6 months ]
  • Change from Baseline in Child Anxiety (Parent report) [ Time Frame: baseline, 6 months ]
  • Change from Baseline in Positive Parenting (Parent report) [ Time Frame: baseline, 6 months ]
  • Change from Baseline in Rules and Consequences (Parent report) [ Time Frame: baseline, 6 months ]
  • Change from Baseline in Positive Communication (Parent report) [ Time Frame: baseline, 6 months ]
  • Change from Baseline in Supporting School Success (Parent report) [ Time Frame: baseline, 6 months ]

Central Contacts and Locations

Central contacts

Allison S Caruthers, PhD

503-412-3770ascaru@uoregon.edu

Locations

Prevention Science Institute

Recruiting

Eugene, Oregon, United States, 97403

Contacts

Allison S Caruthers, PhD

503-412-3770ascaru@uoregon.edu

Principal Investigator:

Anne M Mauricio, PhD

More Information

Sponsor

University of Oregon

Last update posted

Aug 5, 2026

Last verified

Jul, 2026

Keywords

  • digital health
  • implementation science
  • mental health
  • family intervention
  • school-based intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oregon on 2026-08-05.