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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05137327
Other study ID # 19-F-16
Secondary ID R324A190154
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 12, 2021
Est. completion date August 15, 2024

Study information

Verified date December 2023
Source Ohio University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Participants will be 165 general education teachers (teaching Kindergarten through 6th grade) who have room for growth in classroom management skills, along with their classroom of students and one target student with inattentive and/or disruptive behavior problems. Teachers will be recruited over 3 cohorts (1 cohort per year). Teachers will be randomly assigned to one of two consultation conditions and participate for an entire academic year. Teachers in both conditions will be scheduled to receive consultation every other week between August and December and one time per month between January and March. The focus of the consultation will be teacher implementation of universal classroom management practices (Tier 1) and the targeted intervention applied with the target student (either a daily report card and organization intervention; Tier 2). Teachers will be observed weekly and data from observation will be incorporated into consultation sessions. Investigators will examine the main effects of consultation on growth in teacher practices (universal and targeted) and change in proximal and distal student outcomes (classwide and in target students), as well as the mediators and moderators of these effects.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 165
Est. completion date August 15, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria: TEACHER INCLUSION CRITERIA: 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 INCLUSION CRITERIA: - 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. Exclusion Criteria: TEACHER: no exclusionary criteria. STUDENT: Special education eligibility of cognitive disability, autism, or multiple disability.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Classroom Behavior Support (CBS) Condition
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.
Standard Problem Solving Consultation
A standard problem solving approach to teacher consultation that includes observation and brief performance feedback. It represents current best practice in teacher consultation.

Locations

Country Name City State
United States Ohio University Athens Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Teacher Rate of Praise - Whole Class (Tier 1 Teacher Outcome) Using the Student Behavior-Teacher Response (SBTR) observation system, each instance of praise (labeled and unlabeled) is tallied using a frequency count procedure. Using the observation duration, investigators calculate a rate of praise per hour. Scores range from 0 to any upper limit; higher numbers represent more teacher praise statements 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
Secondary Teacher Rate of Praise - Target Student (Tier 2 Teacher Outcome) Using the Student Behavior-Teacher Response (SBTR) observation system, each instance of praise (labeled and unlabeled) directed at the target student is tallied using a frequency count procedure. Using the observation duration, investigators calculate a rate of praise per hour. Scores range from 0 to any upper limit; higher numbers represent more teacher praise statements made to the target student 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 Teacher Rate of Opportunities to Respond (OTR) - Whole Class (Tier 1 Teacher Outcome) Using the Student Behavior-Teacher Response (SBTR) observation system, each Opportunity to Respond (OTR; a question asked to a group of children that facilitates engaged attention) is tallied using a frequency count procedure. Using the observation duration, investigators calculate a rate of OTRs per hour. Scores range from 0 to any upper limit; higher numbers represent more teacher use of OTRs 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
Secondary Teacher Ratings of Target Student Academic Performance - (Tier 2 Student Outcome) Teachers complete the Academic Performance Rating Scale (APRS) on target students at baseline and on a monthly basis following the launch of the Tier 2 intervention. The APRS is a 19-item scale comprised of two subscales assessing children's' Academic Success (i.e., academic achievement) and Academic Productivity (i.e., day-to-day performance). Growth from baseline through study completion, an average of 6 months
Secondary Teacher Ratings of Target Student Behavior - (Tier 2 Student Outcome) Teachers complete the Strengths and Difficulties Questionnaire (SDQ) on target students at baseline and on a monthly basis following the launch of the Tier 2 . The SDQ is a 25 item behavioral screening questionnaire that includes subscales assessing conduct problems and hyperactivity/inattention. Items on each subscale range from 0 to 10; higher scores indicate more problematic behaviors. Change from baseline through study completion, an average of 6 months
Secondary Parent Ratings of Target Student Behavior - (Tier 2 Student Outcome) Parents complete the Strengths and Difficulties Questionnaire (SDQ) on target students at baseline and at the end of the school year (fall and spring). The SDQ is a 25 item behavioral screening questionnaire that includes subscales assessing conduct problems and hyperactivity/inattention. Items on each subscale range from 0 to 10; higher scores indicate more problematic behaviors. Change from baseline to study completion, an average of 6 months
Secondary Teacher Ratings of Target Student ADHD Symptoms - (Tier 2 Student Outcome) Teachers complete the ADHD Rating Scale-5 at baseline and at the end of the school year (fall and spring). The ADHD Rating Scale-5 assess the symptoms of ADHD as described in the DSM-5 (9 symptoms of inattention; 9 symptoms of Hyperactivity-Impulsivity) and associated impairments in functioning. Scores for each subscale range from 0 to 27; higher scores indicate more severe symptoms in that domain. Change from baseline to study completion, an average of 6 months
Secondary Parent Ratings of Target Student ADHD Symptoms - (Tier 2 Student Outcome) Parent complete the ADHD Rating Scale-5 at baseline and at the end of the school year (fall and spring). The ADHD Rating Scale-5 assess the symptoms of ADHD as described in the DSM-5 (9 symptoms of inattention; 9 symptoms of Hyperactivity-Impulsivity) and associated impairments in functioning. Scores for each subscale range from 0 to 27; higher scores indicate more severe symptoms in that domain. Change from baseline to study completion, an average of 6 months
Secondary Teacher Ratings of Positive and Problematic Student Behaviors - (Tier 2 Student Outcome) Teachers complete four, 5-item Daily Behavior Ratings (DBR) on target students at baseline and on a monthly basis following the launch of the Tier 2 intervention. Teachers rate positive behaviors in two domains: Organizational Skills (5 items) and Engagement (5 items) and problem behaviors in two domains: Oppositional (5 items), and Disruptive (5 items) behavior. Scores range from 0 to 35. Higher scores on the positive domains indicate better organization skills and engagement. Higher scores on the negative domains indicate more sever problems in each area. Change from baseline to study completion, an average of 6 months
Secondary Target Student Grade Point Average (GPA) Intervention Year - (Tier 2 Student Outcome) Investigators will collect quarterly grades during the intervention year and calculate a 4-point GPA using core academic subjects. Scores range from 0 to 4; higher scores indicate better academic achievement. Growth from baseline to study completion, an average of 6 months
Secondary Target Student Grade Point Average (GPA) Long Term Follow Up - (Tier 2 Student Outcome) Among students whose parents given consent for us to track their child's GPA in the year following intervention, investigators will collect quarterly grades during the year following the intervention year and calculate a 4-point GPA using core academic subjects. Scores range from 0 to 4; higher scores indicate better academic achievement. Growth from baseline to one year following study completion, an average of 18 months
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