Trial Outcomes & Findings for Multi-level Determinants of Implementation and Sustainment in the Education Sector (NCT NCT04430010)
NCT ID: NCT04430010
Last Updated: 2026-04-29
Results Overview
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.
COMPLETED
NA
130 participants
3 implementation post baseline timepoints: 5 weeks, 10 weeks, 14 weeks AND 4 sustainment timepoints: sustainment baseline, 5 weeks, 10 weeks, 14 weeks
2026-04-29
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 milestones
| Measure |
Teacher Implementation (52 Subject Sample)
Teachers (52 subject sample) 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: 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).
|
Focal Student (78 Subject Student Sample)
One to three students (78 subject student sample) 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: 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).
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
78
|
|
Overall Study
COMPLETED
|
50
|
72
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
Teacher Implementation (52 Subject Sample)
Teachers (52 subject sample) 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: 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).
|
Focal Student (78 Subject Student Sample)
One to three students (78 subject student sample) 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: 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).
|
|---|---|---|
|
Overall Study
3 students w/d when teacher became ineligible
|
0
|
3
|
|
Overall Study
Students were moved to a non-participating teacher classroom
|
0
|
3
|
|
Overall Study
Became ineligible due to professional position change
|
2
|
0
|
Baseline Characteristics
4 students did not have the sex recorded
Baseline characteristics by cohort
| Measure |
Teacher Implementation (52 Subject Sample)
n=52 Participants
Teachers (52 subject sample) 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: 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).
|
Focal Student (78 Subject Student Sample)
n=78 Participants
One to three students (78 subject student sample) 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: 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).
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=52 Participants
|
78 Participants
n=78 Participants
|
78 Participants
n=130 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=52 Participants
|
0 Participants
n=78 Participants
|
52 Participants
n=130 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=52 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=130 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=52 Participants • 4 students did not have the sex recorded
|
26 Participants
n=74 Participants • 4 students did not have the sex recorded
|
76 Participants
n=126 Participants • 4 students did not have the sex recorded
|
|
Sex: Female, Male
Male
|
2 Participants
n=52 Participants • 4 students did not have the sex recorded
|
48 Participants
n=74 Participants • 4 students did not have the sex recorded
|
50 Participants
n=126 Participants • 4 students did not have the sex recorded
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=52 Participants
|
6 Participants
n=78 Participants
|
9 Participants
n=130 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=52 Participants
|
68 Participants
n=78 Participants
|
117 Participants
n=130 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=52 Participants
|
4 Participants
n=78 Participants
|
4 Participants
n=130 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=52 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=52 Participants
|
0 Participants
n=78 Participants
|
3 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=52 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=52 Participants
|
36 Participants
n=78 Participants
|
50 Participants
n=130 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=52 Participants
|
29 Participants
n=78 Participants
|
62 Participants
n=130 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=52 Participants
|
5 Participants
n=78 Participants
|
5 Participants
n=130 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=52 Participants
|
8 Participants
n=78 Participants
|
10 Participants
n=130 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=52 Participants
|
78 participants
n=78 Participants
|
130 participants
n=130 Participants
|
PRIMARY outcome
Timeframe: 3 implementation post baseline timepoints: 5 weeks, 10 weeks, 14 weeks AND 4 sustainment timepoints: sustainment baseline, 5 weeks, 10 weeks, 14 weeksPopulation: Teacher only outcome, 52 subjects enrolled, 52 completed this outcome. Measuring the mean difference between sustatinment BiC adherence and implementation BiC adherence. Data from all of the timepoints were combined and averaged.
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.
Outcome measures
| Measure |
Teacher Implementation (51 Subject Sample)
n=52 Participants
Teachers (51 subject sample) 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: 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).
|
|---|---|
|
Best in Class (BiC) Adherence: Sustainment Average (SU1-SU4) vs. Implementation Post-Baseline Average (IM2-IM4) (Teacher Level Sample)
|
-.075 score on BiC
Standard Deviation .454
|
PRIMARY outcome
Timeframe: 3 implementation post baseline timepoints : 5 weeks, 10 weeks, 14 weeks AND 4 sustainment timepoints: baseline, 5 weeks, 10 weeks, 14 weeksPopulation: Teacher-only outcome; 52 subjects recruited and began the sustainment period, only 50 completed the study. The mean of the timepoints reported is the average difference between the teachers' Competence of delivery of core BEST in CLASS components during the sustainment year in comparison to the implementation year.
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.
Outcome measures
| Measure |
Teacher Implementation (51 Subject Sample)
n=50 Participants
Teachers (51 subject sample) 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: 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).
|
|---|---|
|
Best in Class (BiC) Competence: Sustainment Average (SU1-SU4) vs. Implementation Post-Baseline Average (IM2-IM4) (Teacher Level Sample)
|
.001 score on BiC
Standard Deviation .631
|
PRIMARY outcome
Timeframe: Baseline of sustainment intervention baseline and week 14 of sustainment interventionPopulation: 78 students enrolled, 72 completed
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.
Outcome measures
| Measure |
Teacher Implementation (51 Subject Sample)
n=72 Participants
Teachers (51 subject sample) 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: 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).
|
|---|---|
|
Social Skills Improvement System (SSIS) to Measure Change in Student Disruptive Behavior Problems (Student Level Sample)
|
-3.260 score on SSIS
Standard Deviation 11.646
|
PRIMARY outcome
Timeframe: Baseline of sustainment intervention and week 14 week of sustainment interventionPopulation: 78 students enrolled, 72 students completed.
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
Outcome measures
| Measure |
Teacher Implementation (51 Subject Sample)
n=72 Participants
Teachers (51 subject sample) 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: 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).
|
|---|---|
|
Social Skills Improvement System (SSIS) Social Skills Scale to Measure Change in Student Prosocial Behavior (Student Level Sample)
|
4.603 score on SSIS
Standard Deviation 10.892
|
Adverse Events
Teacher Implementation (52 Subject Sample)
Focal Student (78 Subject Student Sample)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place