NCT05425381

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

3.9 years

First QC Date

June 2, 2022

Last Update Submit

June 16, 2022

Conditions

Keywords

school mental healthinterconnected systems framework

Outcome Measures

Primary Outcomes (10)

  • Change from Baseline on Tiered Fidelity Inventory (TFI) for all Schools

    Tiered Fidelity Inventory (TFI) provides a valid, reliable, and efficient measure of the extent to which school personnel are applying the core features of school-wide positive behavioral interventions and supports.

    Baseline; annually through study completion in first semester of each school year

  • Change Over Time on Interconnected Systems Framework Implementation Inventory (ISFII) for schools in the experimental condition

    The ISFII was developed by the national Interconnected Systems Framework workgroup and includes 15 items for each of the three tiers. Early analyses support the tool's reliability, structural validity, and criterion-related validity as evidenced by strong correlations to similar measures at Tiers 2 and 3 (e.g., Benchmarks for Advanced Tiers; Anderson et al., 2009). The ISFII also appears to discriminate between schools showing some progress on ISF and those making few implementation efforts.

    Once per semester in each intervention school year

  • Change Over Time on Universal Fidelity Tool (UFT) for schools in the experimental condition

    The UFT is a multi-dimensional, three-part measure for social, emotional, and behavioral interventions implemented in schools. The UFT measures intervention selection (the extent to which the intervention was selected based on data and matches identified problem areas), intervention delivery (the extent to which critical components of skill building, fluency, and maintenance are implemented during each session), and intervention monitoring (e.g., dosage, engagement, impacts). The UFT is a new measure with evidence for its reliability and social validity (Holmes et al., 2018).

    Monthly during intervention school years

  • Change Over Time on Team Functioning Measure for All Schools

    For MTSS and child study team meetings in all schools the investigators will request documentation, with one professional designated per meeting to collect these data (e.g., school psychologist, counselor, MH clinician). A form for this purpose will document the meeting length (time), professionals attending and their disciplines (e.g., teacher, school psychologist, clinician, principal), family members/students attending, whether data were reviewed for intervention planning or refinement, and whether follow-up actions from the last meeting were discussed.

    Upon completion of specified meeting type within intervention school years, at least weekly

  • Change Over Time on Intervention Receipt Form (IRF) for All Schools

    The IRF is a spreadsheet completed by all intervention providers (e.g., counselors, MH clinicians, teachers) documenting the referral problem, the intervention provided, and the frequency/dose of the intervention. An intervention identified on any IRF will be considered "quality" if it is an evidence-based practice that matches the referral problem. To determine if an intervention is evidence-based, the investigators will search relevant databases of evidence-based practices (e.g., What Works Clearinghouse).

    Monthly in intervention school years

  • Change from Baseline on BIMAS-2 Standard Form Teacher Ratings for All Schools

    The Behavior Intervention Monitoring Assessment System-2 (BIMAS-2) is a nationally standardized and norm-referenced screening tool directly related to social, emotional, behavioral, and academic functioning in children and adolescents in grades pre-k to 12. Assessments are available for teachers, parents, clinicians, and self (age 12 and over). The BIMAS-2 Standard Form includes 34 items that comprise three problem behavior scales (conduct, negative, affect, and cognitive/attention) and two adaptive scales (social and academic functioning). Evidence of internal consistency, standard error of measurement, test-retest reliability, standard error of prediction, consistency between raters, and validity (content, convergent, divergent) is adequate to strong.

    Baseline, once per semester in intervention school years, and once in follow-up year

  • Change Over Time on BIMAS-2 Flex Assessment Teacher Ratings for All Schools

    The Behavior Intervention Monitoring Assessment System-2 (BIMAS-2) is a nationally standardized and norm-referenced tool directly related to social, emotional, behavioral, and academic functioning in children and adolescents in grades pre-k to 12. Assessments are available for teachers, parents, clinicians, and self (age 12 and over). The BIMAS-2 provides change-sensitive Flex Assessments using a few (1-5) items that enable progress monitoring. This will be completed by teachers only for students referred to Tier 2 or Tier 3 assistance.

    Baseline, once per semester in intervention school years, and once in follow-up year

  • Change from Baseline on Student Self-Report Measures for All Schools

    Combined version of the following rating scales: Brief Problem Checklist-12-item self-report for children 7-13 measuring internalizing and externalizing problems on a 3-point Likert scale Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Subscale-8-item self-report measure for children 5-17 consisting of person-centered measures evaluating mental health PROMIS Pediatric Depression Subscale-8-item self-report measure for children 5-17 consisting of person-centered measures evaluating mental health PBIS School Climate Survey-11-item survey using a 4-point rating scale for grades 3-5 to assess students' perception of school climate along 4 dimensions: school connectedness, school safety, school orderliness, and peer and adult relations Social Emotional Health Survey-Primary- 20-item self-report measure using a 4-point Likert scale to assess adolescents' psychological strengths, including gratitude, zest, optimism, persistence, and prosocial behavior

    Baseline, once per semester in intervention school years, and once in follow-up year

  • Change Over Time in Student-level Achievement and School Records for All Schools

    Student reading and math achievement will be collected at both participating sites using i-Ready (Curriculum Associates, 2020), which the participating districts already administer three times each academic year. i-Ready identifies student strengths and weaknesses by assessing skills relative to grade-level expectations and standards, which allows progress monitoring at the student-level. Districts will provide academic records that include grades, absences, lateness, office discipline referrals, suspensions, and expulsions. The district will also report student entry into special education, increases/decreases in restrictiveness of special education programs, entry into alternative schools, and exit from special services.

    Once per school year through study completion

  • Cost-Effectiveness of IFSE Condition Compared to PBIS+SMH Condition

    An online tracking system will collect data relative to personnel, facilities, materials, equipment, and other inputs (e.g., special travel requirements). The tracking system will record personnel hours and activities, facilities usage, materials, equipment, and special travel, providing data for all major cost ingredients.

    Weekly during intervention school years

Study Arms (2)

Enhanced version of Interconnected Systems Framework (ISFE)

EXPERIMENTAL

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.

Behavioral: Enhanced version of Interconnected Systems Framework

Positive Behavioral Interventions and Supports with Co-located School Mental Health (PBIS+SMH)

ACTIVE COMPARATOR

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).

Behavioral: Positive Behavioral Interventions and Supports with Co-located School Mental Health

Interventions

* District-community Leadership Team to support district-wide implementation and dissemination (Swain-Bradway et al., 2015) * Detailed memoranda of understanding between schools and collaborating mental health centers * Community mental health clinicians meaningfully participate in MTSS teams * Twice-monthly MTSS meetings using systematic teaming strategies (Newton et al., 2012) * Universal screening of students' social, emotional, behavioral, and academic functioning * Data-based decision-making using screening data and data on school and academic functioning for students with and without disabilities * Student-level discipline and intervention data (Blake et al., 2011; Smolkowski et al., 2016) addressed through iterative problem-solving approaches (McIntosh et al., 2018) * Team fidelity measures taken at the start and end of each school year, augmented with monthly fidelity monitoring of Tier 2 and 3 services * A Community of Practice (Wenger, 2010) among the ISFE schools

Also known as: ISFE
Enhanced version of Interconnected Systems Framework (ISFE)

* PBIS, including previously established data-based decision making, teaming, and evidence-based practices at three tiers: universal prevention; early identification and intervention for students with emerging risk; and intensive intervention for students with established problems and/or disabilities (Sugai \& Horner, 2006; Sugai et al., 2014). Most PBIS schools struggle with intervention (Hawken et al., 2009) and the emphasis is typically on behavior, not internalizing student needs, including depression, anxiety, and trauma (Weist et al., 2018). * SMH using a co-located approach, with clinicians implementing treatment separate from the schools' MTSS (Barrett et al., 2013). Research has shown that even when PBIS and community-supported SMH operate in the same school building, in most cases there is no functional collaboration, (Splett et al., 2014). Under this model, SMH services are provided reactively, and students are often in crisis when referred (Dowdy et al., 2010).

Also known as: PBIS+SMH
Positive Behavioral Interventions and Supports with Co-located School Mental Health (PBIS+SMH)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • rd grade

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

East Carolina University

Greenville, North Carolina, 27858, United States

Location

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (10)

  • Dowdy E, Ritchey K, Kamphaus RW. School-Based Screening: A Population-Based Approach to Inform and Monitor Children's Mental Health Needs. School Ment Health. 2010 Dec;2(4):166-176. doi: 10.1007/s12310-010-9036-3. Epub 2010 Apr 27.

    PMID: 21088687BACKGROUND
  • Splett JW, Michael KD, Minard C, Stevens R, Johnson L, Reynolds H, Faerber K, Weist MD. State of the Carolinas: Implementing school mental health and Positive Behavioral Interventions and Supports. Rep Emot Behav Disord Youth, Special Issue. 2014; 14(4):87-95.

    BACKGROUND
  • Sugai G, Horner RR. A promising approach for expanding and sustaining school- wide positive behavior support. School Psych Rev. 2006;35(2):245.

    BACKGROUND
  • Sugai G, Simonsen B, Bradshaw C, Horner R, Lewis TJ. Delivering high quality school-wide positive behavior support in inclusive schools. In: McLeskey,J, Waldron, NL, Spooner, F, Algozzine, B, editors. Handbook of effective inclusive schools. New York: Routledge; 2014. P. 306-21.

    BACKGROUND
  • Hawken L, Adolphson S, Macleod K, Shuman J. Secondary-tier interventions and supports. In Sailor W, Dunlap G, Sugai G, Horner R, editors. Handbook of positive behavior support. New York: Springer; 2009. p. 395-420.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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).

    BACKGROUND
  • Anderson C, Childs K, Kincaid D, Horner RH, George H, Todd AW, Spaulding S. Benchmarks for advanced tiers. Eugene (OR): University of Oregon Educational and Community Supports; 2009.

    BACKGROUND
  • Holmes SR, Owens S, Reinke WM. Maximizing measurement: A universal and multidimensional approach to fidelity. Paper presented at: National Association of School Psychologists Annual Convention; 2018 Feb 13-16; Chicago, IL.

    BACKGROUND
  • McDougal JW, Bardos AN, Meier ST. Behavior Intervention Monitoring Assessment System: Technical manual. Toronto: Multi-Health Systems; 2011.

    BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety DisordersAttention Deficit and Disruptive Behavior DisordersPsychological Trauma

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersNeurodevelopmental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Brandon K Schultz, Ed.D.

    East Carolina University

    PRINCIPAL INVESTIGATOR
  • Mark D Weist, Ph.D.

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
All student participants in the study will be assigned an alpha-numeric code to de-identify their cases. The codes and relevant identifiers will be maintained by a data specialist in the school districts and not shared with the researchers at any point.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 21, 2022

Study Start

February 1, 2022

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

June 21, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations