Clinical trial NCT05425381: Improving Social, Emotional, Behavioral, and Academic Functioning
Official title: Improving Social, Emotional, Behavioral, and Academic Functioning of Elementary School Students Through the Interconnected Systems Framework
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression, Anxiety
Disruptive Behavior Disorder
Trauma, Psychological
Keywords: school mental health
interconnected systems framework
Lead sponsor: East Carolina University
Sponsor class: OTHER
Collaborators: name: University of South Carolina
name: Medical University of South Carolina
name: University of Florida
First posted: 2022-06-21
Enrollment: 1208
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will compare the ISFE model against co-located PBIS and SMH services-an approach commonly used in schools, particularly when community-based mental health clinicians are contracted for services. Thus, schools will be randomly assigned to the experimental conditions before systemic changes are implemented, beginning in the fall of 2022.
Primary purpose: PREVENTION

Brief summary: This efficacy trial will evaluate the impact of an enhanced version of the Interconnected Systems Framework (ISFE) on elementary school-based team functioning, including use of evidence-based practices, and student emotional, behavioral, and academic functioning. The original interconnected systems framework (ISF) model was designed to improve the depth and quality of mental health services delivered within multi-tiered systems of support by integrating Positive Behavioral Interventions and Supports (PBIS) and school mental health (SMH) efforts to provide a continuum of high-quality services for students. Preliminary findings from a prior efficacy study show that the ISF improved team functioning and increased identification and services for students in need, particularly among youth of color, when compared to the other two conditions. Moreover, the ISF led to improvements in student social, emotional, and behavioral functioning. The current study builds on these findings by testing an enhanced version of the ISF designed to advance the model by adding/modifying several core components intended to further increase the impacts for youth with significant emotional and behavioral problems and reduce inequities in discipline and student service delivery.

Detailed description: The Interconnected Systems Framework (ISF) for School Mental Health (SMH) and Positive Behavioral Interventions and Supports (PBIS) has been in development since 2009, involving leaders from national centers dedicated to both school mental health and positive behavioral support. The ISF was fully articulated in two widely disseminated monographs and is being implemented in more than 30 sites around the nation, supported by the national PBIS center (www.pbis.org), the Midwest PBIS network (www.midwestpbis.org), and other national networks focused on PBIS (e.g., www.midatlanticpbis.org, www.schoolbehavioralhealth.org). A recently completed randomized controlled trial (RCT) operating in 24 elementary schools (12 in Charleston, SC, and 12 in Marion, FL), funded by the National Institute of Justice (NIJ) tested the impact of the ISF as compared to PBIS alone, or PBIS with SMH clinicians, operating separately, which is the norm. In the current study, researchers will build from the previous findings to improve implementation efficacy and to better understand the change processes of the ISF. Specifically, researchers will test an ISF enhanced, or ISFE, based on lessons learned from the previous trial, and test its benefits for students with and without disabilities, while also exploring its impact in reducing inequities in discipline and service delivery for racial/ethnic minority youth.

Traditionally, ISF leverages the strengths of PBIS and school mental health to improve the quality of services across three tiers of prevention by providing specific guidance on their systematic interconnection. The ISF includes a district-community leadership team (DCLT), memoranda of agreement between schools and mental health providers, community-based clinicians integrated into problem-solving teams, universal social, emotional, and behavioral screening, team and intervention fidelity monitoring, and district-level communities of practice. The ISFE model tested in this study will have seven enhancements: (1) consistent meetings of the DCLT, which will include education, mental health, other youth-serving systems, and family/youth leaders; (2) clear agreements indicating parameters for an effective problem-solving team with community mental health clinician involvement; (3) improved team meeting procedures and data-based decision making with consistent use of a systematic program to facilitate comprehensive and efficient data review, decision-making, and follow through; (4) improved progress monitoring and fidelity monitoring of targeted and individualized interventions; (5) improved data-based decision making; (6) general enhancements to screening and measurement, including measures with strong psychometric properties; and (7) increased focus on, and better assessment of, student achievement, attendance, tardiness, grades, and discipline outcomes.

Eligibility criteria: Inclusion Criteria:

* Elementary schools from pre-selected North Carolina (NC) and South Carolina (SC) school districts
* Serving K-5 students
* Comparable sociodemographic characteristics and fidelity of PBIS implementation
* Principals' consent to Participate
* Students from participating schools
* 3rd grade

Exclusion Criteria:

* Elementary schools from pre-selected NC and SC school districts
* Serving K-8 students
* Students from participating schools
* Children identified with a moderate or severe intellectual disability resulting in inability to participate in student self-report measures
* Children whose parents have submitted an opt-out form
* Children who opt out the day of data collection

Primary outcomes:
measure: Change from Baseline on Tiered Fidelity Inventory (TFI) for all Schools
timeFrame: Baseline; annually through study completion in first semester of each school year
measure: Change Over Time on Interconnected Systems Framework Implementation Inventory (ISFII) for schools in the experimental condition
timeFrame: Once per semester in each intervention school year
measure: Change Over Time on Universal Fidelity Tool (UFT) for schools in the experimental condition
timeFrame: Monthly during intervention school years
measure: Change Over Time on Team Functioning Measure for All Schools
timeFrame: Upon completion of specified meeting type within intervention school years, at least weekly
measure: Change Over Time on Intervention Receipt Form (IRF) for All Schools
timeFrame: Monthly in intervention school years
measure: Change from Baseline on BIMAS-2 Standard Form Teacher Ratings for All Schools
timeFrame: Baseline, once per semester in intervention school years, and once in follow-up year
measure: Change Over Time on BIMAS-2 Flex Assessment Teacher Ratings for All Schools
timeFrame: Baseline, once per semester in intervention school years, and once in follow-up year
measure: Change from Baseline on Student Self-Report Measures for All Schools
timeFrame: Baseline, once per semester in intervention school years, and once in follow-up year
measure: Change Over Time in Student-level Achievement and School Records for All Schools
timeFrame: Once per school year through study completion
measure: Cost-Effectiveness of IFSE Condition Compared to PBIS+SMH Condition
timeFrame: Weekly during intervention school years
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: East Carolina University
name: Brandon K Schultz, Ed.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Carolina
name: Mark D Weist, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Weist MD, Eber L, Horner R, Splett J, Putnam R, Barrett S, Perales K, Fairchild AJ, Hoover S. Improving multitiered systems of support for students with "internalizing" emotional/behavioral problems. J Posit Behav Interv. 2018 Jul; 20(3):172-84.
citation: Barrett S, Eber L, Weist MD. Advancing education effectiveness: An interconnected systems framework for Positive Behavioral Interventions and Supports (PBIS) and school mental health. Eugene (OR): University of Oregon Press; 2013. 189 p. Supported by the Center for Positive Behavioral Interventions and Supports (funded by the Office of Special Education Programs, US Department of Education).
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