The University of Oregon ACCESS Project
Part of paid clinical trials in Cottage Grove, Oregon.
- Sponsor
- University of Oregon
- Study ID
- NCT07264621
- Status
- Enrolling By Invitation
Conditions
- Depression
- Disparities
- Emotional Regulation
- Externalizing Behavior
- School Attendance
- School Climate
- School Engagement
- School Exclusion
- Stress
- Teacher-student Relationships
Eligibility Criteria
- Sex
- ALL
- Age
- 11 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Inclusive Skill-building Learning Approach (ISLA) — BEHAVIORALISLA is a school-wide, multi-component, instructional and restorative alternative to exclusionary discipline that involves universal prevention grounded in positive, preventative classroom strategies for all students, and layers on additional supports for students in need.Derived from the original School-Wide Positive Behavioral Interventions model (SWPBIS) with roots in social learning theory, ISLA emphasizes that behavior is learned through modeling and teaching, and that environmental factors and the quality of teaching practices influence when and how a behavior is likely to occur. The ISLA model emphasizes ongoing training and coaching of classroom-level prevention strategies and practices that teachers use to promote building strong relationships, preventing school disconnectedness, and improving instructional and restorative alternatives to exclusion.
- Family Check-Up Online (FCU-O) — BEHAVIORALThe 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 — BEHAVIORALThis 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.
Study Details
The goal of this clinical trial is to learn if two behavioral interventions work to reduce office disciplinary referrals, improve attendance, and reduce depression and anxiety in 7th grade students. This project combines two evidence-based programs-the Inclusive Skill-building Learning Approach (ISLA) for school-wide discipline reform and the Family Check-Up Online (FCU-O) for family-centered support-in an adaptive design to examine the unique and additive effects of these interventions on these child behavior outcomes. The main questions it will answer are: 1. What is the relative efficacy of ISLA vs. School-as-Usual? 2. What is the optimal sequencing of these interventions? 3. Which overall sequence of intervention strategies was most effective? Researchers will compare 6 combinations of these interventions to see which combination and sequencing provides the best student outcomes. School personnel participating in the project will be trained to implement the two interventions at their school. They will answer surveys in the fall, winter, and spring of their year of participation. Parent and Youth participants will complete surveys at baseline and then again 6 months and 12 months later.
Key Dates
- Start date
- Aug 13, 2025
- Status verified
- Nov 2025
- Primary completion
- Jun 30, 2028
- Completion
- Mar 31, 2030
Study Design
- Enrollment
- 1,440 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- PREVENTION
Arms
- No Intervention: School-As-Usual (SAU) OnlyStudents were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended 7th grade at a school in the School-As-Usual condition and therefore did not receive the Tier 1 intervention, ISLA. In addition, in January of 7th grade their school behavior and attendance no longer met criteria for assignment to the Tier 2 intervention, the Family Check-up Online. Thus, students in this arm received neither the ISLA nor FCU-O interventions.
- Experimental: SAU + FCU Online OnlyStudents were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended 7th grade at a school in the School-As-Usual condition and therefore did not receive the Tier 1 intervention, ISLA. In January of 7th grade their school behavior and attendance continued to meet criteria for assignment to Tier 2 intervention, and thus they received the Family Check-Up Online. In this arm, students' parents were assigned to receive the Family Check-Up Online digital intervention only (without supportive telehealth coaching).
- Experimental: SAU + FCU Online with Telehealth CoachingStudents were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended 7th grade at a school in the SAU condition, and therefore did not receive the Tier 1 intervention, ISLA. In January of 7th grade their school behavior and attendance continued to meet criteria for Tier 2 intervention, and thus they received the Family Check-Up Online. In this arm, students' parents were assigned to receive the Family Check-Up Online digital intervention and telehealth coaching to support uptake of FCU content.
- Experimental: ISLA intervention + FCU Online OnlyStudents were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended 7th grade at a school which implemented the school-wide Tier 1 intervention, ISLA. In January of 7th grade their school behavior and attendance continued to meet criteria for Tier 2 intervention, and thus they received the Family Check-Up Online. In this arm, students' parents were assigned to receive the Family Check-Up Online digital intervention only (without supportive telehealth coaching).
- Experimental: ISLA intervention+ FCU Online with Telehealth CoachingStudents were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended a school which implemented the school-wide Tier 1 intervention, ISLA. In January of 7th grade their school behavior and attendance continued to meet criteria for Tier 2 intervention, and thus they received the Family Check-Up Online. In this arm, students' parents were assigned to receive the Family Check-Up Online digital intervention with telehealth coaching to support uptake of the FCU content.
- Experimental: ISLA Intervention OnlyStudents were selected to participate in the study based on meeting attendance and behavioral criteria in 6th grade for Tier 2 or Tier 3 school supports. Students in this arm attended a school which implemented the school-wide Tier 1 intervention, ISLA. In January of 7th grade their attendance and behavior no longer met criteria for Tier 2 intervention. Thus, their parents were not offered the FCU Online digital intervention.
Primary Outcome Measure
Change from Baseline in Child Depression (Parent Report) [ Time Frame: baseline, 6 months, 12 months ]
Locations (13)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Lincoln Middle School | Cottage Grove | Oregon | 97424 | - |
| Arts & Technology Academy | Eugene | Oregon | 97405 | - |
| Cal Young Middle School | Eugene | Oregon | 97408 | - |
| Kelly Middle School | Eugene | Oregon | 97404 | - |
| Kennedy Middle School | Eugene | Oregon | 97405 | - |
| Madison Middle School | Eugene | Oregon | 97404 | - |
| Monroe Middle School | Eugene | Oregon | 97401 | - |
| Roosevelt Middle School | Eugene | Oregon | 97405 | - |
| Spencer Butte Middle School | Eugene | Oregon | 97405 | - |
| Agnes Stewart Middle School | Springfield | Oregon | 97478 | - |
| Briggs Middle School | Springfield | Oregon | 97477 | - |
| Hamlin Middle School | Springfield | Oregon | 97477 | - |
| Thurston Middle School | Springfield | Oregon | 97478 | - |
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