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) — BEHAVIORAL
    ISLA 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) — 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.
  • FCU-Online with telehealth coaching — 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.

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) Only
    Students 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 Only
    Students 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 Coaching
    Students 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 Only
    Students 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 Coaching
    Students 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 Only
    Students 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)

FacilityCityStateZIPSite coordinators
Lincoln Middle SchoolCottage GroveOregon97424-
Arts & Technology AcademyEugeneOregon97405-
Cal Young Middle SchoolEugeneOregon97408-
Kelly Middle SchoolEugeneOregon97404-
Kennedy Middle SchoolEugeneOregon97405-
Madison Middle SchoolEugeneOregon97404-
Monroe Middle SchoolEugeneOregon97401-
Roosevelt Middle SchoolEugeneOregon97405-
Spencer Butte Middle SchoolEugeneOregon97405-
Agnes Stewart Middle SchoolSpringfieldOregon97478-
Briggs Middle SchoolSpringfieldOregon97477-
Hamlin Middle SchoolSpringfieldOregon97477-
Thurston Middle SchoolSpringfieldOregon97478-

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