Improving Social, Emotional, Behavioral, and Academic Functioning

Depression, Anxiety Clinical Trial

Official title:

Improving Social, Emotional, Behavioral, and Academic Functioning of Elementary School Students Through the Interconnected Systems Framework

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05425381
• Other study ID #: R324A210179
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 15, 2025

Study information

• Verified date: June 2022
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1208
• Est. completion date: December 15, 2025
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Depression, Anxiety
• Disruptive Behavior Disorder
• Mental Disorders
• Problem Behavior
• Psychological Trauma
• Trauma, Psychological

Intervention

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

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina
United States	East Carolina University	Greenville	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
East Carolina University	Medical University of South Carolina, University of Florida, University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (10)

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.

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).

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. Epub 2010 Apr 27. — View Citation

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.

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.

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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