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The University of Oregon ACCESS Project

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University of Oregon

Status

Invitation-only

Conditions

Teacher-student Relationships
Disparities
School Exclusion
Externalizing Behavior
School Attendance
Emotional Regulation
School Engagement
Depression
School Climate
Stress

Treatments

Behavioral: Family Check-Up Online (FCU-O)
Behavioral: FCU-Online with telehealth coaching
Behavioral: Inclusive Skill-building Learning Approach (ISLA)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT07264621
STUDY00001745
1P50MH139449 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,440 estimated patients

Sex

All

Ages

11+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

1,440 participants in 6 patient groups

School-As-Usual (SAU) Only
No Intervention group
Description:
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.
SAU + FCU Online Only
Experimental group
Description:
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).
Treatment:
Behavioral: Family Check-Up Online (FCU-O)
SAU + FCU Online with Telehealth Coaching
Experimental group
Description:
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.
Treatment:
Behavioral: FCU-Online with telehealth coaching
ISLA intervention + FCU Online Only
Experimental group
Description:
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).
Treatment:
Behavioral: Inclusive Skill-building Learning Approach (ISLA)
Behavioral: Family Check-Up Online (FCU-O)
ISLA intervention+ FCU Online with Telehealth Coaching
Experimental group
Description:
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.
Treatment:
Behavioral: Inclusive Skill-building Learning Approach (ISLA)
Behavioral: FCU-Online with telehealth coaching
ISLA Intervention Only
Experimental group
Description:
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.
Treatment:
Behavioral: Inclusive Skill-building Learning Approach (ISLA)

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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