Depression, AnxietyNCT05425381
Improving Social, Emotional, Behavioral, and Academic Functioning
A study testing Enhanced version of Interconnected Systems Framework and Positive Behavioral Interventions and Supports with Co-located School Mental Health in people with Depression, Anxiety and Disruptive Behavior Disorder, run by East Carolina University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Disruptive Behavior Disorder, Trauma, Psychological
- What is being tested?
- Enhanced version of Interconnected Systems Framework and Positive Behavioral Interventions and Supports with Co-located School Mental Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,208 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2022to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of South Carolina
Columbia, South Carolina, 29208
East Carolina University
Greenville, North Carolina, 27858
About this study
Official title: Improving Social, Emotional, Behavioral, and Academic Functioning of Elementary School Students Through the Interconnected Systems Framework
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.
Read the 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.
- Being tested
- Enhanced version of Interconnected Systems Framework, Positive Behavioral Interventions and Supports with Co-located School Mental Health
- Keywords
- school mental health, interconnected systems framework
- Medical subject headings
- Depression, Anxiety Disorders, Attention Deficit and Disruptive Behavior Disorders, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced version of Interconnected Systems FrameworkBehavioural
Also called ISFE
- 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 HealthBehavioural
Also called PBIS+SMH
- 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Positive Behavioral Interventions and Supports with Co-located School Mental Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Weekly during intervention school years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Feb 2022
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina, Medical University of South Carolina, University of Florida
- Responsible party
- Principal investigator, Brandon Kyle Schultz, East Carolina University
- Investigators
- Brandon K Schultz, Ed.D., Principal investigator, East Carolina UniversityMark D Weist, Ph.D., Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425381
- Sponsor's protocol ID
- R324A210179
- Status last verified
- Jun 2022
- First submitted
- 2 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21088687Splett 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 at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Social, Emotional, Behavioral, and Academic Functioning of Elementary School Students Through the Interconnected Systems Framework
- ClinicalTrials.gov ID
- NCT05425381
- Acronym / sponsor ID
- R324A210179
- Keywords
- school mental health, interconnected systems framework
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,208 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- University of South Carolina, Medical University of South Carolina, University of Florida
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Enhanced version of Interconnected Systems Framework (ISFE) | Experimental | Behavioral: Enhanced version of Interconnected Systems FrameworkThe 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. |
| Positive Behavioral Interventions and Supports with Co-located School Mental Health (PBIS+SMH) | Active comparator | Behavioral: Positive Behavioral Interventions and Supports with Co-located School Mental HealthMental 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 may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced version of Interconnected Systems FrameworkAlso: ISFE* 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 | Behavioural | Enhanced version of Interconnected Systems Framework (ISFE) |
| Positive Behavioral Interventions and Supports with Co-located School Mental HealthAlso: PBIS+SMH* 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). | Behavioural | Positive Behavioral Interventions and Supports with Co-located School Mental Health (PBIS+SMH) |
Primary outcome
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
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.
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
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.
Change Over Time on Universal Fidelity Tool (UFT) for schools in the experimental condition
Time frame: Monthly during intervention school years
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).
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
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.
Change Over Time on Intervention Receipt Form (IRF) for All Schools
Time frame: Monthly in intervention school years
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).
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
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.
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
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.
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
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
Change Over Time in Student-level Achievement and School Records for All Schools
Time frame: Once per school year through study completion
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.
Cost-Effectiveness of IFSE Condition Compared to PBIS+SMH Condition
Time frame: Weekly during intervention school years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Background: PubMed 21088687Dowdy 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.
- BackgroundSplett 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.
- BackgroundSugai G, Horner RR. A promising approach for expanding and sustaining school- wide positive behavior support. School Psych Rev. 2006;35(2):245.
- BackgroundSugai 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.
- BackgroundHawken 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.
- BackgroundWeist 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.
- BackgroundBarrett 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).
- BackgroundAnderson 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.
- BackgroundHolmes 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.
- BackgroundMcDougal JW, Bardos AN, Meier ST. Behavior Intervention Monitoring Assessment System: Technical manual. Toronto: Multi-Health Systems; 2011.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon K Schultz, Ed.D. principal investigator
East Carolina University
Mark D Weist, Ph.D. principal investigator
University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced version of Interconnected Systems Framework and Positive Behavioral Interventions and Supports with Co-located School Mental Health in people with Depression, Anxiety and Disruptive Behavior Disorder, run by East Carolina University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05425381, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.