NCT05137327

Brief Summary

The goal of the study is to conduct a randomized clinical trial to evaluate the impact of the Classroom Behavior Support Program (CBS; a multi-component, individually-tailored teacher consultation program) on teachers' classroom management practices (universal and targeted) and resulting student behavioral and educational outcomes relative to a best practices comparison consultation condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

July 18, 2024

Status Verified

December 1, 2023

Enrollment Period

2.8 years

First QC Date

November 28, 2021

Last Update Submit

July 16, 2024

Conditions

Keywords

inattentiondisruptive behavior

Outcome Measures

Primary Outcomes (4)

  • Teacher Percent Appropriate Response to Rule Violation (ARRV) - Whole Class (Tier 1 Teacher Outcome)

    Using the Student Behavior-Teacher Response (SBTR) observation system, each student rule violation is tallied using a frequency count procedure. Following each rule violation, teacher responses are coded. Investigators calculate a percent appropriate response for each observation. Scores range from 0% to 100%; higher scores represent better response. Observations are conducted weekly for the duration of the trial (30-minutes each). Data are averaged across observations between consultation sessions.

    Growth from baseline through study completion, an average of 8 months

  • Teacher Percent Appropriate Response to Rule Violation (ARRV) - Target Student (Tier 2 Teacher Outcome)

    Once the target student is identified and consented (typically 2 months after the start of school), target student behaviors are observed using the Using the Student Behavior-Teacher Response (SBTR) observation system. Each target student rule violation is tallied using a frequency count procedure. Following each rule violation, teacher responses are coded. Investigators calculate a percent appropriate response for each observation. Scores range from 0% to 100%; higher scores represent better response. Observations are conducted weekly for the duration of the trial (30-minutes each). Data are averaged across observations between consultation sessions.

    Growth from baseline through study completion, an average of 6 months

  • Whole Class Student Rule Violations (Tier 1 Student Outcome)

    Using the Student Behavior-Teacher Response (SBTR) observation system, each student rule violation is tallied using a frequency count procedure. Using the observation duration, investigators calculate a rate per hour. Scores range from 0 to any upper limit; higher numbers represent more classwide rule violations per hour. Observations are conducted weekly for the duration of the trial (30-minutes each). Data are averaged across observations between consultation sessions.

    Change from baseline through study completion, an average of 8 months

  • Target Student Rule Violations (Tier 2 Student Outcome)

    Using the Student Behavior-Teacher Response (SBTR) observation system, target student rule violations are tallied using a frequency count procedure. Using the observation duration, investigators calculate a rate per hour. Scores range from 0 to any upper limit; higher numbers represent more target student rule violations per hour. Observations are conducted weekly for the duration of the trial (30-minutes each). Data are averaged across observations between consultation sessions.

    Change from baseline through study completion, an average of 6 months

Secondary Outcomes (11)

  • Teacher Rate of Praise - Whole Class (Tier 1 Teacher Outcome)

    Change from baseline through study completion, an average of 8 months

  • Teacher Rate of Praise - Target Student (Tier 2 Teacher Outcome)

    Change from baseline through study completion, an average of 6 months

  • Teacher Rate of Opportunities to Respond (OTR) - Whole Class (Tier 1 Teacher Outcome)

    Change from baseline through study completion, an average of 8 months

  • Teacher Ratings of Target Student Academic Performance - (Tier 2 Student Outcome)

    Growth from baseline through study completion, an average of 6 months

  • Teacher Ratings of Target Student Behavior - (Tier 2 Student Outcome)

    Change from baseline through study completion, an average of 6 months

  • +6 more secondary outcomes

Study Arms (2)

Classroom Behavior Support (CBS) Condition

EXPERIMENTAL

Consultants follow the problem-solving process used in the comparison condition and attempt to address barriers to integrity using the knowledge, skills, beliefs, or stress components in the CBS manual. Consultants conduct a Values Interview, so teacher values can be used in the individual goal setting and decision making process. Consultants are trained to (a) incorporate the teacher's values into the problem-solving process, (b) elicit change talk from teachers using techniques borrowed from Motivational Interviewing, and (c) engage in Socratic questioning and cognitive restructuring for beliefs that may be barriers to integrity (e.g., "should" statements). Enhanced performance feedback involves highlighting connections between teacher integrity and child outcomes and using this as a catalyst for a knowledge, skills, beliefs, or stress component. Consultants use change rulers to elicit motivation to achieve the stated goals.

Behavioral: Classroom Behavior Support (CBS) Condition

Standard Problem Solving Comparison Condition

ACTIVE COMPARATOR

Consultation in the comparison condition follows a 5-step problem solving approach and provide brief performance feedback procedures that mirror (in duration, content, and process) best practice procedures (Gilbertson et al., 2007; Noell et al., 1997). The guiding principles for this condition are that the performance feedback portion of the session should be limited to 5 to 10 minutes and unless the teacher initiates discussion of other content, the problem solving should remain student-focused, rather than teacher-focused. Discussion on teacher values and beliefs, and attempts to facilitate change talk, are contra-indicated. If the teacher initiates discussion of knowledge, beliefs, or skills, the consultant may answer questions, but may not use strategies associated with Motivational Interview or Cognitive-Behavioral Therapy (CBT) or strategies in CBS condition. We have separate scripts and checklists for each condition.

Behavioral: Standard Problem Solving Consultation

Interventions

An individualized teacher consultation program that includes observation and performance feedback and techniques borrowed from Motivational Interviewing and Cognitive Behavioral Therapy (CBS). It is designed to address barriers to implementation and improve teacher practices and student outcomes.

Classroom Behavior Support (CBS) Condition

A standard problem solving approach to teacher consultation that includes observation and brief performance feedback. It represents current best practice in teacher consultation.

Standard Problem Solving Comparison Condition

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Teacher of a general education class in a participating elementary school (teacher grades K-6th grade) with at least one of the following from observation screening data.
  • Below 51% response to student rule violations;
  • A rate of praise per hour that falls below the 30th percentile for teachers of the same grade;
  • A rate of student rule violations that exceeds the 70th percentile for that grade.
  • Student must spend at least 50% of his/her day in the teacher's classroom
  • Student must receive at three or more scores that are lower than a 3 on a positive Daily Behavior Rating (DBR) subscale or three or more scores higher than 3 on a negative DBR subscale.
  • Parents must provide consent.

You may not qualify if:

  • STUDENT: Special education eligibility of cognitive disability, autism, or multiple disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio University

Athens, Ohio, 45701', United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityProblem Behavior

Interventions

Cystathionine beta-Synthase

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehavioral SymptomsBehaviorChild Behavior

Intervention Hierarchy (Ancestors)

Hydro-LyasesCarbon-Oxygen LyasesLyasesEnzymesEnzymes and Coenzymes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Teachers are unaware of the consultation condition to which they are assigned.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Within a given school building, teachers will be stratified on three characteristics prior to randomization: (1) grade bands (K-2 and 3-5), (2) Global Classroom Management Competencies based on baseline observations and (3) teacher beliefs based on baseline ratings. This will ensure that similar numbers of teachers with these characteristics are in each condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

November 28, 2021

First Posted

November 30, 2021

Study Start

August 12, 2021

Primary Completion

June 1, 2024

Study Completion

June 15, 2024

Last Updated

July 18, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Within one year of end of the project period, the final project data will be fully de-identified and stored in SPSS files with accompanying documents that describe the variables, the measures, and the project procedures. We will post on our center's web pages that data requests for this study can be made online. Instructions for submitting such requests will be clearly described on the web pages. All requests, related correspondence, and outcome of the requests will be stored in our center.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
This will become available 1 year after the end of the study and will be available for 10 years after we publish the main findings of the study.
Access Criteria
Receiving parties must (a) identify the primary contact person and multiple means of contact, (b) identify any other persons who will have access to the data, (c) specify the research questions and the nature of the analyses, and confirm that the contact person/s has the expertise to use the data to achieve those goals, (d) specify the planned outlet for the findings, and (e) sign an agreement that (1) they will maintain the dataset in a private and confidential location, not share the data with any parties outside those specified in (a) and (b), and not manipulate the data for the purposes of attempting to identify participants, and (2) they will give Drs. Owens and Evans the opportunity to review and comment on any product prior to dissemination, and give them the opportunity to be a co-author on the product if desired.
More information

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