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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04430010
Enrollment
130
Registered
2020-06-12
Start date
2021-10-01
Completion date
2026-04-30
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evidence Based Programs in Schools

Brief 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.

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.

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).

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

This study enrolled two arms, Teacher Implementation (52 enrolled) and Focal Student (78 enrolled) The study enrolled 130 total

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Best in Class (BiC) Adherence: Sustainment Average (SU1-SU4) vs. Implementation Post-Baseline Average (IM2-IM4) (Teacher Level Sample)3 implementation post baseline timepoints: 5 weeks, 10 weeks, 14 weeks AND 4 sustainment timepoints: sustainment baseline, 5 weeks, 10 weeks, 14 weeksThe 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)3 implementation post baseline timepoints : 5 weeks, 10 weeks, 14 weeks AND 4 sustainment timepoints: baseline, 5 weeks, 10 weeks, 14 weeksThe 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)Baseline of sustainment intervention baseline and week 14 of sustainment interventionProblem 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)Baseline of sustainment intervention and week 14 week of sustainment interventionThe 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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBryce D McLeod, PhD

Virginia Commonwealth University

Participant flow

Recruitment details

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.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
78 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
52 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
49 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
36 Participants
Race (NIH/OMB)
More than one race
5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants
Race (NIH/OMB)
White
62 Participants
Region of Enrollment
United States
130 participants
Sex: Female, Male
Female
76 Participants
Sex: Female, Male
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 520 / 78
other
Total, other adverse events
0 / 520 / 78
serious
Total, serious adverse events
0 / 520 / 78

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026