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Integrated School-Based Mental Health Program for Student Mental Health Challenges
N/A
Waitlist Available
Led By Mark D Weist, Ph.D.
Research Sponsored by East Carolina University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once per school year through study completion
Awards & highlights
Study Summary
This trial will evaluate an enhanced version of the Interconnected Systems Framework to see if it improves team functioning, use of evidence-based practices, and student emotional, behavioral, and academic functioning.
Who is the study for?
This trial is for 3rd-grade students from certain North Carolina and South Carolina elementary schools that serve K-5. Schools must have similar sociodemographic characteristics, agree to participate, and already implement PBIS with fidelity. Children with moderate or severe intellectual disabilities or those who opt-out are excluded.Check my eligibility
What is being tested?
The study tests an enhanced Interconnected Systems Framework (ISFE) in elementary schools to improve team functioning and student support services, aiming to boost kids' social, emotional, behavioral, and academic outcomes. It builds on a model integrating Positive Behavioral Interventions and Supports with school mental health efforts.See study design
What are the potential side effects?
Since this intervention involves educational and behavioral strategies rather than medical treatments, traditional side effects are not applicable. However, there may be unintended consequences such as increased stress or resistance among staff implementing new practices.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, once per semester in intervention school years, and once in follow-up year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, once per semester in intervention school years, and once in follow-up year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change Over Time in Student-level Achievement and School Records for All Schools
Change Over Time on BIMAS-2 Flex Assessment Teacher Ratings for All Schools
Change Over Time on Interconnected Systems Framework Implementation Inventory (ISFII) for schools in the experimental condition
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced version of Interconnected Systems Framework (ISFE)Experimental Treatment1 Intervention
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.
Group II: Positive Behavioral Interventions and Supports with Co-located School Mental Health (PBIS+SMH)Active Control1 Intervention
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).
Find a Location
Who is running the clinical trial?
University of South CarolinaOTHER
211 Previous Clinical Trials
119,251 Total Patients Enrolled
East Carolina UniversityLead Sponsor
107 Previous Clinical Trials
37,601 Total Patients Enrolled
Medical University of South CarolinaOTHER
932 Previous Clinical Trials
7,393,052 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Only students from certain schools are allowed to participate.I am in the 3rd grade.I work with students in grades K through 5.My child has a moderate or severe intellectual disability that prevents them from self-reporting.I am a 3rd grader at a participating school.My child chose not to participate in data collection today.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced version of Interconnected Systems Framework (ISFE)
- Group 2: Positive Behavioral Interventions and Supports with Co-located School Mental Health (PBIS+SMH)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment currently enrolling participants?
"As per the data posted on clinicaltrials.gov, this trial is no longer recruiting participants. This information was first published in February 2022 and last updated during June of that same year. Despite this particular study having ended recruitment efforts, 524 other studies are presently open for participant enrollment."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
University of South Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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