The University of Oregon ACCESS Project

NCT07264621 | Enrolling By Invitation

• 2 other identifiers: STUDY000017451P50MH139449
• Study Type: interventional
• Target: 1,440
• Locations: 1 country
• Sites: 13

Brief 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. 1.What is the relative efficacy of ISLA vs. School-as-Usual?
2. 2.What is the optimal sequencing of these interventions?
3. 3.Which overall sequence of intervention strategies was most effective?

Conditions

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

Keywords

school-based intervention; family intervention; middle school; SMART trial

Outcome Measures

Primary Outcomes (11)

• Change from Baseline in Child Depression (Parent Report)

  Parents report on their child's depression using the eight item PHQ-8. Parents are asked to indicate how often their child has experienced symptoms over the last two weeks using a 4-pt Likert scale: 0 =not at all, 1=several days, 2=more than half the days, 3= nearly every day. Scores for individual items are summed together. Higher scores indicate greater child depression.

  baseline, 6 months, 12 months

• Change from Baseline in Child Depression (Student Report)

  Students report on their symptoms of depression using the eight item PHQ-8. Students are asked to indicate how often they have experienced symptoms over the last two weeks using a 4-pt Likert scale: 0 =not at all, 1=several days, 2=more than half the days, 3= nearly every day. Scores for individual items are summed together. Higher scores indicate greater child depression.

  baseline, 6 months, 12 months

• Change from Baseline in Child Anxiety (Parent Report)

  Parents report on their child's anxiety using the 7 item GAD-7. Parents are asked to indicate how often their child has experienced symptoms over the past 2 weeks using a 4-pt Likert scale: 0= not at all, 1=several days, 2=more than half the days, and 3= nearly every day. Ratings of the 7 items are summed together. Higher scores indicate greater child anxiety.

  baseline, 6 months, 12 months

• Change from Baseline in Child Anxiety (Student Report)

  Students report on their symptoms of anxiety using the 7 item GAD-7. Students are asked to indicate how often they have experienced symptoms over the past 2 weeks using a 4-pt Likert scale: 0= not at all, 1=several days, 2=more than half the days, and 3= nearly every day. Ratings of the 7 items are summed together. Higher scores indicate greater child anxiety.

  baseline, 6 months, 12 months

• Change from Baseline in Student Problem Behaviors (Parent Report)

  The Strengths and Difficulties Questionnaire (SDQ; Goodman 1997) is a 25-item behavioral screening questionnaire about psychosocial problems for youth, and includes competencies or strengths in addition to assessing problems. The SDQ is equally divided across five scales measuring emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behavior. Parents are provided statements and asked to indicate how true each statement has been for their child over the past 6 months using a 3-pt Likert scale: 0=Not True, 1=Somewhat True, and 2=Certainly True. Ratings are summed, and higher scores indicate more problem behavior.

  baseline, 6 months, 12 months

• Change from Baseline in Student Problem Behaviors (Student Report)

  The Strengths and Difficulties Questionnaire (SDQ; Goodman 1997) is a 25-item behavioral screening questionnaire about psychosocial problems for youth, and includes competencies or strengths in addition to assessing problems. The SDQ is equally divided across five scales measuring emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behavior. Students are provided statements and asked to indicate how true each statement has been for them over the past 6 months using a 3-pt Likert scale: 0=Not True, 1=Somewhat True, and 2=Certainly True. Ratings are summed, and higher scores indicate more problem behavior.

  baseline, 6 months, 12 months

• Change from Baseline in School Climate (Student Report)

  The School Climate Survey: Secondary (SCS-S) is a 36-item school climate rating scale (Center on PBIS, 2022) intended to obtain middle and high school student perception ratings of school climate. It has 8 subscales: school connectedness, peer social support, adult social support, cultural acceptance, social/ civic learning, physical environment, school safety, and order and discipline. Respondents use a 4-point Likert scale: 1=Strongly Disagree, 2 = Somewhat Disagree, 3 = Somewhat Agree, and 4 = Strongly Agree. To compute the overall school climate score, item responses are summed and then divided by the total number of items. Higher overall scores reflect a more positive sense of the school environment.

  baseline, 6 months, 12 months

• Change from Baseline in School Climate (Teacher Report)

  The School Climate Survey: School Personnel (Center on PBIS, 2022) includes 29 items and 5 subscales, including staff connectedness, structure for learning, school safety, physical environment, peer and adult relations, and parent involvement. School personnel rate items with a four-point Likert scale: 1=Strongly Disagree, 2=Somewhat Disagree, 3=Somewhat Agree, and 4=Strongly Agree. To compute the overall school climate score, item responses are summed and then divided by the total number of items. Higher overall scores reflect a more positive sense of the school environment.

  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)

  The number of office disciplinary referrals (ODRs), in-school (ISS), and out-of-school suspensions (OSS) will be gleaned from school records and aggregated at the school-level.

  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)

  The number of office disciplinary referrals (ODRs), in-school (ISS), and out-of-school suspensions (OSS) received by participating students will be gleaned from school records and recorded at the student-level for two academic years (6th grade and 7th grade).

  baseline, 12 months

• Change from Baseline in Number of Days Absent from School (Student-Level)

  The number of days that participating students were absent from school will be gleaned from school records and recorded at the student-level for two academic years (6th grade and 7th grade).

  Time Frame: baseline, 12 months

Study Arms (6)

School-As-Usual (SAU) Only

NO INTERVENTION

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

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).

Behavioral: Family Check-Up Online (FCU-O)

SAU + FCU Online with Telehealth Coaching

EXPERIMENTAL

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.

Behavioral: FCU-Online with telehealth coaching

ISLA intervention + FCU Online Only

EXPERIMENTAL

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).

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

ISLA intervention+ FCU Online with Telehealth Coaching

EXPERIMENTAL

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.

Behavioral: Inclusive Skill-building Learning Approach (ISLA); Behavioral: FCU-Online with telehealth coaching

ISLA Intervention Only

EXPERIMENTAL

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.

Behavioral: Inclusive Skill-building Learning Approach (ISLA)

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.

ISLA Intervention Only; ISLA intervention + FCU Online Only; ISLA intervention+ FCU Online with Telehealth Coaching

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.

ISLA intervention + FCU Online Only; SAU + FCU Online Only

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.

ISLA intervention+ FCU Online with Telehealth Coaching; SAU + FCU Online with Telehealth Coaching

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 must be employed by a participating middle school; and
• School staff must be willing and interested in receiving training and support throughout implementation
• 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):
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oregon: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (13)

Lincoln Middle School

Cottage Grove, Oregon, 97424, United States

Location

Monroe Middle School

Eugene, Oregon, 97401, United States

Location

Kelly Middle School

Eugene, Oregon, 97404, United States

Location

Madison Middle School

Eugene, Oregon, 97404, United States

Location

Arts & Technology Academy

Eugene, Oregon, 97405, United States

Location

Kennedy Middle School

Eugene, Oregon, 97405, United States

Location

Roosevelt Middle School

Eugene, Oregon, 97405, United States

Location

Spencer Butte Middle School

Eugene, Oregon, 97405, United States

Location

Cal Young Middle School

Eugene, Oregon, 97408, United States

Location

Briggs Middle School

Springfield, Oregon, 97477, United States

Location

Hamlin Middle School

Springfield, Oregon, 97477, United States

Location

Agnes Stewart Middle School

Springfield, Oregon, 97478, United States

Location

Thurston Middle School

Springfield, Oregon, 97478, United States

Location

MeSH Terms

Conditions

Emotional Regulation; Depression

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Behavioral Symptoms

Study Officials

• Beth Stormshak, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

• Rhonda Nese, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential Multiple Assignment Randomization Trial (SMART)

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): March 31, 2030
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After completion of the project funding period, de-identified, final research data generated in the research activities, along with metadata, descriptors, and protocols, will be shared with the broader scientific community through dissemination efforts and uploads to the NIMH Data Archive.
• Access Criteria: External researcher requests for de-identified individual-level data must be accompanied by a signed Data Use Agreement, and researchers must document that they are working under an institution with a Federal Wide Assurance (FWA).To optimize usage of the data, the website at the University of Oregon's ACCESS Center will provide clear instructions for accessing the data.

Locations

US (13)