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

NCT04430010 | Completed Results

• 2 other identifiers: HM20019081R01MH124439
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Evidence Based Programs in Schools

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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

  Baseline of sustainment intervention and week 14 week of sustainment intervention

Study Arms (2)

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.

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.

Behavioral: BEST in CLASS

Interventions

BEST in CLASS BEHAVIORAL

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; Teacher Implementation

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of Florida

Gainesville, Florida, 32611, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Interventions

Bestrophins; Artifacts

Intervention Hierarchy (Ancestors)

Chloride Channels; Ion Channels; Membrane Transport Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Eye Proteins; Membrane Glycoproteins; Membrane Proteins; Investigative Techniques

Results Point of Contact

• Title: Bryce McLeod, PI
• Organization: Virginia Commonwealth University

bmcleod@vcu.edu

(804) 827-5230

Study Officials

• Bryce D McLeod, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: October 1, 2021
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)