- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04430010
Multi-level Determinants of Implementation and Sustainment in the Education Sector
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Gainesville, Florida, United States, 32611
- University of Florida
-
-
Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
- Assent to participate if the child is 7 years or older
Exclusion Criteria:
Teacher participants
- do not teach in general education Kindergarten, 1st, 2nd, or 3rd grades
- were not part of the BEST in CLASS Elementary intervention condition
- do not consent to participate
- do not speak fluent English
- do not have at least one student that meets the inclusion criteria
Children participants
- caregivers do not provide permission for participation
- caregiver(s) do not speak proficient English or Spanish (caregiver consent provided in both languages)
- are not proficient in English
- do not screen in as demonstrating risk for EBD
- participated as a focal child in the classroom of a participating treatment teacher in the previous efficacy trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Teacher Implementation
Teachers will implement the BEST in CLASS treatment in their classrooms.
Teachers were trained and coached in delivering the intervention during their participation in the prior efficacy trial.
In the school year of the present study, the teacher implements the intervention without further support from a coach.
|
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).
|
|
Experimental: Focal Student
One to three students within a participating teacher's classroom are nominated by the teacher and screened for elevated risk of emotional behavior challenges.
The teacher delivers the BEST in CLASS intervention to the focal child(ren) in their classroom.
|
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 |
|---|---|---|
|
Best in Class (BiC) Adherence: Sustainment Average (SU1-SU4) vs. Implementation Post-Baseline Average (IM2-IM4) (Teacher Level Sample)
Time Frame: 3 implementation post baseline timepoints: 5 weeks, 10 weeks, 14 weeks AND 4 sustainment timepoints: sustainment baseline, 5 weeks, 10 weeks, 14 weeks
|
The difference in the degree to which the 52 teacher sample adheres to the BiC treatment during the post-baseline implementation phase from the prior efficacy trial, in comparison to the same sample's adherence during the present sustainment trial.
Adherence is measured during observations as measure by independent observers on the TREATMENT INTEGRITY INSTRUMENT FOR ELEMENTARY SETTINGS (TIES) Adherence scale.
TIES-A is a 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).
Higher scores are associated with greater adherence.
|
3 implementation post baseline timepoints: 5 weeks, 10 weeks, 14 weeks AND 4 sustainment timepoints: sustainment baseline, 5 weeks, 10 weeks, 14 weeks
|
|
Best in Class (BiC) Competence: Sustainment Average (SU1-SU4) vs. Implementation Post-Baseline Average (IM2-IM4) (Teacher Level Sample)
Time Frame: 3 implementation post baseline timepoints : 5 weeks, 10 weeks, 14 weeks AND 4 sustainment timepoints: baseline, 5 weeks, 10 weeks, 14 weeks
|
The difference in the competence with which the teacher sample delivers the BiC treatment during the post-baseline implementation phase from the prior efficacy trial, in comparison to the same sample's competence during the present sustainment trial.
Competence is measured during observations as measure by independent observers on the TREATMENT INTEGRITY INSTRUMENT FOR ELEMENTARY SETTINGS (TIES) Competence scale.
TIES-C is a scale of BEST in CLASS practices.
Teachers are rated on the competence (quality) of each practice on a scale from 1 (not at all) to 7 (extensively).
Higher scores are associated with greater competence.
|
3 implementation post baseline timepoints : 5 weeks, 10 weeks, 14 weeks AND 4 sustainment timepoints: baseline, 5 weeks, 10 weeks, 14 weeks
|
|
Social Skills Improvement System (SSIS) to Measure Change in Student Disruptive Behavior Problems (Student Level Sample)
Time Frame: Baseline of sustainment intervention baseline and week 14 of sustainment intervention
|
Problem Behaviors (Standard Score) The mean difference between the teacher-reported problem behavior standard score exhibited by the focal student sample (78 enrolled, 72 completed) from Fall (SU1) to Spring (SU4) of the sustainment year. Student (72 sample size) problem behaviors will be measured by the Social Skills Improvement System (SSIS) problem behavior scale. Higher scores represent more problem behaviors. SU1 v. SU4 (sustainment baseline v. sustainment 14 weeks). The core composite scores for Social Skills and Problem Behaviors have a mean of 100. Frequency Ratings: Items are rated on a 4-point scale: 0 = Never, 1 = Seldom, 2 = Often, 3 = Almost Always, 4=Always. |
Baseline of sustainment intervention baseline and week 14 of sustainment intervention
|
|
Social Skills Improvement System (SSIS) Social Skills Scale to Measure Change in Student Prosocial Behavior (Student Level Sample)
Time Frame: Baseline of sustainment intervention and week 14 week of sustainment intervention
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The mean difference in teacher-reported social skills exhibited by the focal student sample (78 enrolled, 72 completed) from Fall (SU1) to Spring (SU4) of the sustainment year.
Student (72 sample size) prosocial behaviors will be measured by the Social Skills Improvement System (SSIS) social skills scale.
Social Skills (Standard Score).
Higher scores represent higher level of social skills.
SU1 v. SU4 (sustainment baseline v. sustainment 14 weeks).
The core composite scores for Social Skills and Problem Behaviors have a mean of 100.
Frequency Ratings: Items are rated on a 4-point scale: 0 = Never, 1 = Seldom, 2 = Often, 3 = Almost Always, 4=Always
|
Baseline of sustainment intervention and week 14 week of sustainment intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bryce D McLeod, PhD, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20019081
- R01MH124439 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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