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Multi-level Determinants of Implementation and Sustainment in the Education Sector

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04430010
Recruitment Status : Suspended (Schools opening remotely has prevented recruitment)
First Posted : June 12, 2020
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
The purpose of this study is to learn more about teachers' sustainment of use of core components of BEST in CLASS in a follow-up study.

Condition or disease Intervention/treatment Phase
Evidence Based Programs in Schools Behavioral: BEST in CLASS Not Applicable

Detailed Description:
The goal of this study is to help understand how to successfully implement and sustain evidence based programs (EBP) in the education sector. The study will look at how questions such as what teacher, program, and school characteristics impact sustainment of the EBP BEST in CLASS, what modifications to BEST in CLASS represent a sustained program, and how do teacher, program, and school characteristics influence sustainment of BEST in CLASS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 588 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Multi-level Determinants of Implementation and Sustainment in the Education Sector
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Arm Intervention/treatment
Experimental: Implementation
Teachers will implement the BEST in CLASS treatment in their classrooms
Behavioral: BEST in CLASS
BEST in CLASS is a Tier-2 evidence based program (EBP) that has demonstrated effectiveness at reducing children's Disruptive Behavior Problems (DBPs) and risk for Emotional and Behavioral Disorders (EBDs)




Primary Outcome Measures :
  1. Change in Program Adherence [ Time Frame: baseline to 9 months ]
    Change in the degree to which the teacher adheres to the BEST in CLASS treatment during observations as measure by the TREATMENT INTEGRITY INSTRUMENT FOR ELEMENTARY SETTINGS (TIES) Adherence scale. The TIES-A is an 18 item scale of BEST in CLASS practices. Teachers are rated on the presence (use) of each practice on a scale from 1 (not at all) to 7 (extensively). Scores are summed giving a range of 18 to 126. Higher scores are associated with greater adherence.

  2. Change in Program Competence [ Time Frame: baseline to 9 months ]
    Change in the degree to which the teacher adheres to the BEST in CLASS treatment during observations as measure by the TREATMENT INTEGRITY INSTRUMENT FOR ELEMENTARY SETTINGS (TIES) Competence scale. The TIES-C is an 18 item scale of BEST in CLASS practices. For all practices observed (greated than 1 on the Adherence scale) teachers are rated on the competency of their use of the practice on a scale from 1 (not at all) to 7 (extensively). Scores are summed giving a range of 0 to 126. Higher scores are associated with greater competence.

  3. Change in student disruptive behavior problems [ Time Frame: Baseline to 9 months ]
    Student disruptive behaviors will be measured by the Social Skills Improvement System (SSIS) total problems scale. Higher scores represent more problem behaviors.

  4. Change in student prosocial behavior [ Time Frame: Baseline to 9 months ]
    Student prosocial behaviors will be measured by the Social Skills Improvement System (SSIS) social skills scale. Higher scores represent more prosocial behavior.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Teacher participants

  • teach in general education Kindergarten, 1st, 2nd, or 3rd grade
  • consent to participate
  • proficient in English
  • participated as a BEST in CLASS teacher who received coaching in the prior year

Family participants

  • proficient in English
  • have a school-age child or children
  • consent to participate

Children participants

  • enrolled in a general Kindergarten, 1st, 2nd or 3rd grade classroom
  • proficient in English
  • at elevated risk for EBD
  • demonstration of externalizing behaviors that interfere with participation in the classroom (e.g., disruption, aggression) as indicated by teacher rating
  • parental/guardian consent to participate

Exclusion Criteria:

Teacher participants

  • do not teach in general education Kindergarten, 1st, 2nd, or 3rd grades
  • were not part of the BEST in CLASS intervention condition in the year prior
  • do not consent to participate
  • do not speak fluent English
  • do not have at least one student that meets the inclusion criteria

Family participants

  • do not speak proficient English
  • do not provide consent
  • do not have elementary aged children will be excluded.

Children participants

  • caregivers do not provide permission for participation
  • caregiver(s) do not speak proficient English
  • are not proficient in English
  • do not screen in as demonstrating risk for EBD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04430010


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Bryce D McLeod, PhD Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04430010    
Other Study ID Numbers: HM20019081
R01MH124439 ( U.S. NIH Grant/Contract )
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No