By InvitationNot Applicable

The University of Oregon ACCESS Project

United States1,440 participantsStarted 2025-08-13

Plain-language summary

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.

Who can participate

Age range

11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

School Inclusion Criteria: * The middle school must be located in Oregon and serve a population with high levels of NIH-defined health disparity; and * The middle school must have a history of collaboration with the National PBIS Technical Assistance Center or the Northwest PBIS network. School Staff Inclusion Criteria: * School staff must be employed by a participating middle school; and * School staff must be willing and interested in receiving training and support throughout implementation Family Inclusion Criteria: * The target child must attend a middle school which has been randomly assigned to receive the ISLA intervention or School-as-Usual; * The target child must be in 7th grade and between the ages of 11 and 14; * The caregiver must be the parent or legal guardian of the target child; * The target child must exhibit at least one of the following risk factors during the prior academic year (6th grade): * 2 or more office discipline referrals; * poor attendance, i.e., missing 2 more school days per month; and * The caregiver must have a smartphone with text messaging capability, access to email and internet. Family Exclusion Criteria: Families will be excluded from the study if: * the caregiver is unable to read in either English or Spanish; * either member of the parent-child dyad chooses not to participate (i.e., both members of the dyad need to consent/ assent); or * the family is already participating in another study at the University of Oregon's Prevent…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.