The University of Oregon ACCESS Project

Official title

Adaptive Multi-tiered School-based Prevention to Promote Youth Mental Health and Create Equitable and Sustainable Systems of Care

Overview

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.

Detailed description

In the past decade, youth mental health and behavior concerns have been some of the most significant challenges in schools, exacerbated by the COVID-19 pandemic. A high percentage of adolescents experience mental health distress, but only a fraction of them recieve adequate services, especially in underserved communities. School-based services face barriers such as limited funding, staffing shortages, and a lack of evidence-based programming. Mental health issues are driven by a combination of individual and systemic risk factors, including inequitable school policies, caregiver stress, and family history of mental health disorders. Youth from minoritized backgrounds face higher stressors, further impacting their mental health. Due to the complexity and depth of these issues, an approach that intervenes on a school- and family-level could show significant reduction in mental health and behavioral concerns which would otherwise precipitate into a lifetime of cascading negative outcomes.

Effective strategies that can aid in this youth mental health epidemic include family-centered treatments and school-wide programs to reduce exclusionary discipline practices, which disproportionately affect marginalized students and contribute to the school-to-prison pipeline. Family engagement in mental health interventions has shown positive, long-term effects, but participation rates remain low, with most school programs focusing on individual students rather than families.

This project aims to highlight the importance of embedding mental health services in schools by way of providing schools with equitable skill-building supports to improve student social and behavioral problem-solving, as well as providing families with a brief, strengths-based, digital health intervention for families to reduce mental health and behavioral concerns by improving emotional regulation and family relationships. Digital health interventions, like web-based programs, offer a promising solution to reach underserved families and 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. Integrating a family-centered intervention that promotes positive and nurturing familial relationships with a systemic intervention that addresses inequitable discipline practices in schools provides a promising and innovative approach for reducing the youth mental health crisis across multiple systems, including home, school, and communities. This approach aims to reduce mental health issues by addressing both school and family dynamics. The project evaluates the effectiveness and sustainability of these interventions using a multi-level model and randomized trials.

Interventions

• Behavioral Inclusive Skill-building Learning Approach (ISLA)
  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
• Behavioral Family Check-Up Online (FCU-O)
  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.
• 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

Primary outcome measures

• Change from Baseline in Child Depression (Parent Report) [Time frame: baseline, 6 months, 12 months]
• Change from Baseline in Child Depression (Student Report) [Time frame: baseline, 6 months, 12 months]
• Change from Baseline in Child Anxiety (Parent Report) [Time frame: baseline, 6 months, 12 months]
• Change from Baseline in Child Anxiety (Student Report) [Time frame: baseline, 6 months, 12 months]
• Change from Baseline in Student Problem Behaviors (Parent Report) [Time frame: baseline, 6 months, 12 months]
• Change from Baseline in Student Problem Behaviors (Student Report) [Time frame: baseline, 6 months, 12 months]
• Change from Baseline in School Climate (Student Report) [Time frame: baseline, 6 months, 12 months]
• Change from Baseline in School Climate (Teacher Report) [Time frame: Fall, Winter, and Spring of one academic year (e.g., baseline, 6 months, 10 months)]
• Change from Baseline in Number of ODRs, In-School Suspensions, and Out-of-School Suspensions (School-Level) [Time frame: Fall, winter, and spring of two academic years (baseline, 6 months, 9 months, 12 months, 18 months, 21 months)]
• Change from Baseline in Number of ODRs, In-School Suspensions, and Out-of-School Suspensions (Student-Level) [Time frame: baseline, 12 months]

Eligibility criteria

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 Prevention Science Institute.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 13 centers

• Lincoln Middle School — Cottage Grove
• Monroe Middle School — Eugene
• Kelly Middle School — Eugene
• Madison Middle School — Eugene
• Arts & Technology Academy — Eugene
• Kennedy Middle School — Eugene
• Roosevelt Middle School — Eugene
• Spencer Butte Middle School — Eugene
• … and 5 more centers

Identifiers

NCT: NCT07264621 · STUDY00001745 · 1P50MH139449

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗