- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04430010
Multi-level Determinants of Implementation and Sustainment in the Education Sector
July 13, 2023 updated by: Virginia Commonwealth University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
588
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32611
- Recruiting
- University of Florida
-
Contact:
- Maureen Conroy, PhD
- Phone Number: 352-273-4382
- Email: mconroy@coe.ufl.edu
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University
-
Contact:
- Kevin Sutherland, PhD
- Phone Number: 804-827-2652
- Email: kssuther@vcu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Implementation
Teachers will implement the BEST in CLASS treatment in their classrooms
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline to 9 months
|
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.
|
baseline to 9 months
|
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.
|
Baseline to 9 months
|
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.
|
Baseline to 9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bryce D McLeod, PhD, Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 13, 2021
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
June 10, 2020
First Submitted That Met QC Criteria
June 10, 2020
First Posted (Actual)
June 12, 2020
Study Record Updates
Last Update Posted (Actual)
July 14, 2023
Last Update Submitted That Met QC Criteria
July 13, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- HM20019081
- R01MH124439 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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