Evidence Based Programs in SchoolsNCT04430010
Multi-level Determinants of Implementation and Sustainment in the Education Sector
A study testing BEST in CLASS in people with Evidence Based Programs in Schools, run by Virginia Commonwealth University at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Evidence Based Programs in Schools
- What is being tested?
- BEST in CLASS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2021to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida
Gainesville, Florida, 32611
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
- Conditions
- Evidence Based Programs in Schools
- Being tested
- BEST in CLASS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEST in CLASSBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Teacher Implementation | Experimental | 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. Receives: Behavioral: BEST in CLASS |
| Focal Student | Experimental | 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. Receives: Behavioral: BEST in CLASS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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
Measured: Baseline of sustainment intervention and week 14 week of sustainment intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Oct 2021
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Evidence Based Programs in SchoolsStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study enrolled two arms, Teacher Implementation (52 enrolled) and Focal Student (78 enrolled) The study enrolled 130 total
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Bryce D McLeod, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430010
- Sponsor's protocol ID
- HM20019081
- Other IDs
- R01MH124439
- Status last verified
- May 2026
- First submitted
- 10 Jun 2020
- Last updated
- 2 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-level Determinants of Implementation and Sustainment in the Education Sector
- ClinicalTrials.gov ID
- NCT04430010
- Acronym / sponsor ID
- HM20019081
- Conditions
- Evidence Based Programs in Schools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Posted 29 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study enrolled two arms, Teacher Implementation (52 enrolled) and Focal Student (78 enrolled) The study enrolled 130 total
| Arm | Type | Receives |
|---|---|---|
| Teacher Implementation | Experimental | Behavioral: BEST in CLASSTeachers 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. |
| Focal Student | Experimental | Behavioral: BEST in CLASSOne 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEST in CLASSBEST 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). | Behavioural | Focal Student, Teacher Implementation |
Primary outcome
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.
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.
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.
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryce D McLeod, PhD principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BEST in CLASS in people with Evidence Based Programs in Schools, run by Virginia Commonwealth University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.