- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05425381
Improving Social, Emotional, Behavioral, and Academic Functioning
Improving Social, Emotional, Behavioral, and Academic Functioning of Elementary School Students Through the Interconnected Systems Framework
Study Overview
Status
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Greenville, North Carolina, United States, 27858
- East Carolina University
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South Carolina
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Columbia, South Carolina, United States, 29208
- University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Enhanced version of Interconnected Systems Framework (ISFE)
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.
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Other Names:
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ACTIVE_COMPARATOR: Positive Behavioral Interventions and Supports with Co-located School Mental Health (PBIS+SMH)
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).
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change from Baseline on Tiered Fidelity Inventory (TFI) for all Schools
Time Frame: Baseline; annually through study completion in first semester of each school year
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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.
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Baseline; annually through study completion in first semester of each school year
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Change Over Time on Interconnected Systems Framework Implementation Inventory (ISFII) for schools in the experimental condition
Time Frame: Once per semester in each intervention school year
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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.
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Once per semester in each intervention school year
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Change Over Time on Universal Fidelity Tool (UFT) for schools in the experimental condition
Time Frame: Monthly during intervention school years
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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).
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Monthly during intervention school years
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Change Over Time on Team Functioning Measure for All Schools
Time Frame: Upon completion of specified meeting type within intervention school years, at least weekly
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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.
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Upon completion of specified meeting type within intervention school years, at least weekly
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Change Over Time on Intervention Receipt Form (IRF) for All Schools
Time Frame: Monthly in intervention school years
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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).
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Monthly in intervention school years
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Change from Baseline on BIMAS-2 Standard Form Teacher Ratings for All Schools
Time Frame: Baseline, once per semester in intervention school years, and once in follow-up year
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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.
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Baseline, once per semester in intervention school years, and once in follow-up year
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Change Over Time on BIMAS-2 Flex Assessment Teacher Ratings for All Schools
Time Frame: Baseline, once per semester in intervention school years, and once in follow-up year
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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.
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Baseline, once per semester in intervention school years, and once in follow-up year
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Change from Baseline on Student Self-Report Measures for All Schools
Time Frame: Baseline, once per semester in intervention school years, and once in follow-up year
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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
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Baseline, once per semester in intervention school years, and once in follow-up year
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Change Over Time in Student-level Achievement and School Records for All Schools
Time Frame: Once per school year through study completion
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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
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Cost-Effectiveness of IFSE Condition Compared to PBIS+SMH Condition
Time Frame: Weekly during intervention school years
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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.
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Weekly during intervention school years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brandon K Schultz, Ed.D., East Carolina University
- Principal Investigator: Mark D Weist, Ph.D., University of South Carolina
Publications and helpful links
General Publications
- 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.
- 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.
- Sugai G, Horner RR. A promising approach for expanding and sustaining school- wide positive behavior support. School Psych Rev. 2006;35(2):245.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- McDougal JW, Bardos AN, Meier ST. Behavior Intervention Monitoring Assessment System: Technical manual. Toronto: Multi-Health Systems; 2011.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R324A210179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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