CClinicalTrials.gg
CompletedNCT04430010Updated Jun 2, 2026Results posted

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

An interventional study of BEST in CLASS in Evidence Based Programs in Schools, sponsored by Virginia Commonwealth University. Completed at 2 sites in United States. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Non-randomized
Ages
5 Years and older
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Evidence Based Programs in Schools
03

In context

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (actual)

Study arms

  • 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.

    Behavioral: BEST in CLASS

  • 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.

    Behavioral: BEST in CLASS

Interventions

  • BehavioralBEST 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).

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What researchers measure

Primary outcomes

  1. Best in Class (BiC) Adherence: Sustainment Average (SU1-SU4) vs. Implementation Post-Baseline Average (IM2-IM4) (Teacher Level Sample)

    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.

    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

  2. Best in Class (BiC) Competence: Sustainment Average (SU1-SU4) vs. Implementation Post-Baseline Average (IM2-IM4) (Teacher Level Sample)

    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.

    Time frame: 3 implementation post baseline timepoints : 5 weeks, 10 weeks, 14 weeks AND 4 sustainment timepoints: baseline, 5 weeks, 10 weeks, 14 weeks

  3. Social Skills Improvement System (SSIS) to Measure Change in Student Disruptive Behavior Problems (Student Level Sample)

    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.

    Time frame: Baseline of sustainment intervention baseline and week 14 of sustainment intervention

  4. Social Skills Improvement System (SSIS) Social Skills Scale to Measure Change in Student Prosocial Behavior (Student Level Sample)

    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

    Time frame: Baseline of sustainment intervention and week 14 week of sustainment intervention

07

Results

Posted Apr 29, 2026

Participant flow

There are 52 subjects in the teacher sample and 78 subjects in the student sample. Only 50 teachers and 72 students completed the study interventions.

Participant flow — Overall Study
MilestoneTeacher Implementation (52 Subject Sample)Focal Student (78 Subject Student Sample)
Started5278
Completed5072
Not completed26
Withdrew: 3 students w/d when teacher became ineligible03
Withdrew: Students were moved to a non-participating teacher classroom03
Withdrew: Became ineligible due to professional position change20

Outcome measures

PrimaryBest in Class (BiC) Adherence: Sustainment Average (SU1-SU4) vs. Implementation Post-Baseline Average (IM2-IM4) (Teacher Level Sample)

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.

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
Reported as:
Mean · score on BiC
Best in Class (BiC) Adherence: Sustainment Average (SU1-SU4) vs. Implementation Post-Baseline Average (IM2-IM4) (Teacher Level Sample)
score on BiCTeacher Implementation (51 Subject Sample)
Best in Class (BiC) Adherence: Sustainment Average (SU1-SU4) vs. Implementation Post-Baseline Average (IM2-IM4) (Teacher Level Sample)-.075 ± .454
PrimaryBest in Class (BiC) Competence: Sustainment Average (SU1-SU4) vs. Implementation Post-Baseline Average (IM2-IM4) (Teacher Level Sample)

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.

Time frame:
3 implementation post baseline timepoints : 5 weeks, 10 weeks, 14 weeks AND 4 sustainment timepoints: baseline, 5 weeks, 10 weeks, 14 weeks
Reported as:
Mean · score on BiC
Best in Class (BiC) Competence: Sustainment Average (SU1-SU4) vs. Implementation Post-Baseline Average (IM2-IM4) (Teacher Level Sample)
score on BiCTeacher Implementation (52 Subject Sample Enrolled, 50 Subjects Completed This Outcome)
Best in Class (BiC) Competence: Sustainment Average (SU1-SU4) vs. Implementation Post-Baseline Average (IM2-IM4) (Teacher Level Sample).001 ± .631
PrimarySocial Skills Improvement System (SSIS) to Measure Change in Student Disruptive Behavior Problems (Student Level Sample)

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.

Time frame:
Baseline of sustainment intervention baseline and week 14 of sustainment intervention
Reported as:
Mean · score on SSIS
Social Skills Improvement System (SSIS) to Measure Change in Student Disruptive Behavior Problems (Student Level Sample)
score on SSISFocal Student (72 Subject Student Sample)
Social Skills Improvement System (SSIS) to Measure Change in Student Disruptive Behavior Problems (Student Level Sample)-3.260 ± 11.646
PrimarySocial Skills Improvement System (SSIS) Social Skills Scale to Measure Change in Student Prosocial Behavior (Student Level Sample)

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

Time frame:
Baseline of sustainment intervention and week 14 week of sustainment intervention
Reported as:
Mean · score on SSIS
Social Skills Improvement System (SSIS) Social Skills Scale to Measure Change in Student Prosocial Behavior (Student Level Sample)
score on SSISFocal Student (72 Subject Student Sample)
Social Skills Improvement System (SSIS) Social Skills Scale to Measure Change in Student Prosocial Behavior (Student Level Sample)4.603 ± 10.892

Adverse events

Collected over During both of the study timeframes (IM-Implementation) and SU (Sustainment): IM2 = 5 weeks of implementation IM3 = 10 weeks of implementation IM4 = 14 weeks of implementation SU1 = baseline of sustainment SU2 = 5 weeks of sustainment SU3 = 10 weeks of sustainment SU4 = 14 weeks of sustainment. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Teacher Implementation (52 Subject Sample)0/52 (0%)0/52 (0%)0/52 (0%)
Focal Student (78 Subject Student Sample)0/78 (0%)0/78 (0%)0/78 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Teacher Implementation (52 Subject Sample)Focal Student (78 Subject Student Sample)Total
<=18 years07878
Between 18 and 65 years52052
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Teacher Implementation (52 Subject Sample)Focal Student (78 Subject Student Sample)Total
Female502676
Male24850
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Teacher Implementation (52 Subject Sample)Focal Student (78 Subject Student Sample)Total
Hispanic or Latino369
Not Hispanic or Latino4968117
Unknown or Not Reported044
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Teacher Implementation (52 Subject Sample)Focal Student (78 Subject Student Sample)Total
American Indian or Alaska Native000
Asian303
Native Hawaiian or Other Pacific Islander000
Black or African American143650
White332962
More than one race055
Unknown or Not Reported2810
Region of Enrollment
Region of Enrollment(participants)Teacher Implementation (52 Subject Sample)Focal Student (78 Subject Student Sample)Total
United States5278130
08

Study locations

2 sites
  • University of Florida
    Gainesville, Florida 32611, United States
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 18, 2022
  • Informed consent form · Aug 26, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04430010
Lead sponsor
Virginia Commonwealth University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Jun 12, 2020
Start date
Oct 1, 2021
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026
Results posted
Apr 29, 2026
Last update
Jun 2, 2026

Study contacts

Bryce D McLeod, PhD
principal investigator · Virginia Commonwealth University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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