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Search / Trial NCT05425381

Improving Social, Emotional, Behavioral, and Academic Functioning

Launched by EAST CAROLINA UNIVERSITY · Jun 16, 2022

Trial Information

Current as of November 11, 2025

Enrolling by invitation

Keywords

School Mental Health Interconnected Systems Framework

ClinConnect Summary

This is a school-based study that tests an enhanced version of the Interconnected Systems Framework (ISFE). The goal is to see if ISFE helps schools connect their behavior supports (PBIS) with school-based mental health services in a way that improves how students feel and behave and, in turn, how they do in school. Schools are randomly assigned to use the enhanced ISFE or to continue with the usual PBIS plus on-site mental health clinicians. It’s a prevention study, and researchers will track how well the program is implemented and whether students show better emotional, behavioral, and academic outcomes over time.

Who can participate and what to expect: The study takes place in elementary schools in North Carolina and South Carolina and focuses on 3rd-grade students in those schools. Principals must consent to participate, and schools should have similar levels of existing PBIS use. Students can participate unless their parent/guardian opts out or a child has a condition (such as a moderate to severe intellectual disability) that would prevent them from completing self-report measures. About 1,200 students are involved across multiple districts. Participants will have surveys, school records, and routine data collected, and teachers, school staff, and mental health clinicians will participate in team meetings and data reviews to monitor implementation and student progress. The study started recruitment in 2022 and is expected to finish around December 2025. It is led by East Carolina University and the University of South Carolina, with other collaborating institutions, and does not involve drugs.

Gender

ALL

Eligibility criteria

  • 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

About East Carolina University

East Carolina University (ECU) is a leading academic institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, ECU leverages its diverse expertise in medicine, nursing, and public health to foster advancements in patient care. The university is committed to ethical practices and collaboration, ensuring rigorous methodologies and compliance with regulatory standards. By engaging in multidisciplinary approaches, ECU aims to contribute significantly to the understanding and treatment of various health conditions, ultimately enhancing health outcomes for diverse populations.

Locations

Greenville, North Carolina, United States

Columbia, South Carolina, United States

Patients applied

0 patients applied

Trial Officials

Brandon K Schultz, Ed.D.

Principal Investigator

East Carolina University

Mark D Weist, Ph.D.

Principal Investigator

University of South Carolina

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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