Integrated School-Based Mental Health Program for Student Mental Health Challenges

Enrolling by invitation at 1 trial location

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: East Carolina University

Disqualifiers: Moderate/severe intellectual disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new school program to support students with emotional and behavioral challenges. It tests an enhanced framework that combines Positive Behavioral Interventions and Supports (PBIS) with school mental health efforts to improve mental health services. The goal is to enhance student behavior, emotions, and academic performance. The trial seeks 3rd-grade students in elementary schools in North and South Carolina that already use PBIS. As an unphased trial, this study provides a unique opportunity for students to benefit from innovative mental health support strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this enhanced version of the Interconnected Systems Framework is safe for student mental health challenges?

Research has shown that the improved Interconnected Systems Framework (ISFE) enhances collaboration among school teams and offers more support for students, particularly youth of color. This framework integrates well into schools and enhances students' social, emotional, and behavioral well-being without causing harm.

Studies have demonstrated that Positive Behavioral Interventions and Supports with Co-located School Mental Health (PBIS+SMH) reduces problem behaviors and improves mental health in schools. This widely used method has proven to be generally safe and effective for students.

Although specific safety data is unavailable, it is important to note that this trial does not test a drug or medical treatment. Instead, it evaluates school programs, which typically pose low risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to create a more integrated approach to mental health in schools. The Enhanced version of the Interconnected Systems Framework (ISFE) stands out by weaving together Positive Behavioral Interventions and Supports (PBIS) with School Mental Health (SMH) to form a unified system. Unlike typical practices, where these elements often run parallel without true connection, ISFE emphasizes interdisciplinary collaboration and evidence-based practices to optimize support across all levels of need. This interconnection is expected to deliver more cohesive and efficient mental health support for students, potentially transforming the way schools address mental health challenges.

What evidence suggests that this trial's treatments could be effective for student mental health challenges?

Research has shown that the original Interconnected Systems Framework (ISF) helped school teams collaborate more effectively and provided increased support for students, particularly students of color. This support led to improvements in students' social, emotional, and behavioral well-being. In this trial, one group of participants will receive the Enhanced version of the Interconnected Systems Framework (ISFE), which refines key components to better assist students with significant challenges. Another group will receive Positive Behavioral Interventions and Supports with Co-located School Mental Health (PBIS+SMH). Studies have demonstrated that combining these systems can effectively address students' mental health needs. While PBIS focuses on improving social behavior, integrating it with school mental health efforts offers comprehensive support. ^{1 2 3 5 6}

Who Is on the Research Team?

Brandon K Schultz, Ed.D.

Principal Investigator

East Carolina University

Mark D Weist, Ph.D.

Principal Investigator

University of South Carolina

Are You a Good Fit for This Trial?

This trial is for 3rd-grade students from certain North Carolina and South Carolina elementary schools that serve K-5. Schools must have similar sociodemographic characteristics, agree to participate, and already implement PBIS with fidelity. Children with moderate or severe intellectual disabilities or those who opt-out are excluded.

Inclusion Criteria

Elementary schools from pre-selected North Carolina (NC) and South Carolina (SC) school districts serving K-5 students with comparable sociodemographic characteristics and fidelity of PBIS implementation

Principals' consent to participate

I am a 3rd grader at a participating school.

Exclusion Criteria

Elementary schools from pre-selected NC and SC school districts serving K-8 students

My child has a moderate or severe intellectual disability that prevents them from self-reporting.

Children whose parents have submitted an opt-out form

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the enhanced Interconnected Systems Framework (ISFE) in schools, focusing on improving team functioning and student outcomes

Intervention school years

Weekly meetings for team functioning and intervention planning

Follow-up

Participants are monitored for changes in student self-report measures, team functioning, and fidelity of implementation

Once in follow-up year

Once per semester

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced version of Interconnected Systems Framework
• Positive Behavioral Interventions and Supports with Co-located School Mental Health

Trial Overview The study tests an enhanced Interconnected Systems Framework (ISFE) in elementary schools to improve team functioning and student support services, aiming to boost kids' social, emotional, behavioral, and academic outcomes. It builds on a model integrating Positive Behavioral Interventions and Supports with school mental health efforts.

How Is the Trial Designed?

Group I: Enhanced version of Interconnected Systems Framework (ISFE) Experimental Treatment 1 Intervention

The ISFE addresses limitations of positive behavioral interventions and supports (PBIS) and school mental health (SMH) and improves the quality of services within the three tiers of multi-tiered systems of support (MTSS) by providing specific guidance on their systematic interconnection. Meaningful interconnection requires effective interdisciplinary collaboration, well-functioning teams, data-based decision making, and effective selection and implementation of evidence-based practices. The original interconnected systems framework (ISF) capitalizes on PBIS' strong implementation infrastructure and universal prevention strategies and combines these elements with SMH enhancements to Tiers 2 and 3 to achieve a comprehensive continuum of evidence-based practices. The ISFE leverages the strengths of PBIS and SMH to create one integrated system of care that achieves synergy and economies of scale.

Group II: Positive Behavioral Interventions and Supports with Co-located School Mental Health (PBIS+SMH) Active Control 1 Intervention

Mental health clinicians will be assigned and can work with MTSS teams (or not). Otherwise, there will be no special guidance. We expect this condition to mimic typical practices in schools, where PBIS and SMH efforts are co-located, but not meaningfully interconnected. In other words, we expect parallel functioning (Splett et al., 2014).

Who Is Running the Clinical Trial?

East Carolina University

Lead Sponsor

Trials

111

Recruited

42,400+

University of South Carolina

Collaborator

Trials

233

Recruited

122,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Citations

1. ies.ed.gov ies.ed.gov/use-work/awards/improving-social-emotional-behavioral-and-academic-functioning-elementary-school-children-through

Improving Social, Emotional, Behavioral, and Academic ... The purpose of this efficacy study is to evaluate the impact of an enhanced version of the Interconnected Systems Framework (ISFE) on elementary school-based ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05425381

Improving Social, Emotional, Behavioral, and Academic ... This efficacy trial will evaluate the impact of an enhanced version of the Interconnected Systems Framework (ISFE) on elementary school-based team ...

3. schoolmentalhealth.org schoolmentalhealth.org/media/som/microsites/ncsmh/documents/archives/asmh-2019/presentations-2019/CS-10.08.-The-Interconnected-Systems-Framework.pdf

Implementing an Interconnected Systems Framework, The ... Data-Based Decision Making: Are data representative of school, home and community behavior collected, analyzed and used for decision making, including outcome/ ...

4. ospi.k12.wa.us ospi.k12.wa.us/sites/default/files/2023-08/isfmonograph.pdf

ADVANCING EDUCATION EFFECTIVENESS: Development of an Interconnected Systems Framework for School Mental Health. ... interconnected data framework allows school and mental health decision ...

5. withpower.com withpower.com/trial/phase-defiant-disorder-oppositional-1-2022-839c4

Integrated School-Based Mental Health Program for ... Research shows that schools using the Interconnected Systems Framework (ISF) delivered more mental health interventions and had fewer discipline issues compared ...

6. ies.ed.gov ies.ed.gov/learn/blog/integrating-intervention-systems-address-student-mental-health-and-social-emotional-behavioral

Integrating Intervention Systems to Address Student Mental ... NCSER is featuring an IES-funded study on student behavioral supports and interventions that best address the mental health needs of students.