ADHDCBSNCT05137327
Classroom Behavior Support (CBS) Project
A study testing Classroom Behavior Support (CBS) Condition and Standard Problem Solving Consultation in people with ADHD, run by Ohio University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- Classroom Behavior Support (CBS) Condition and Standard Problem Solving Consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2021to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- TEACHER: no exclusionary criteria.
- STUDENT: Special education eligibility of cognitive disability, autism, or multiple disability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining Outcomes of a Multi-Component, Individually-Tailored Consultation Process Focused on Classroom Management for Teachers
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.
Read the detailed 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.
- Conditions
- ADHD
- Being tested
- Classroom Behavior Support (CBS) Condition, Standard Problem Solving Consultation
- Keywords
- inattention, disruptive behavior
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classroom Behavior Support (CBS) ConditionBehavioural
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 ConsultationBehavioural
A standard problem solving approach to teacher consultation that includes observation and brief performance feedback. It represents current best practice in teacher consultation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Problem Solving Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline through study completion, an average of 6 months
Secondary outcomes (11)
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.
Measured: Change from baseline through study completion, an average of 8 months
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.
Measured: Change from baseline through study completion, an average of 6 months
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.
Measured: Change from baseline through study completion, an average of 8 months
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).
Measured: Growth from baseline through study completion, an average of 6 months
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.
Measured: Change from baseline through study completion, an average of 6 months
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.
Measured: Change from baseline to study completion, an average of 6 months
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.
Measured: Change from baseline to study completion, an average of 6 months
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.
Measured: Change from baseline to study completion, an average of 6 months
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.
Measured: Change from baseline to study completion, an average of 6 months
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.
Measured: Growth from baseline to study completion, an average of 6 months
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.
Measured: Growth from baseline to one year following study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start12 Aug 2021
- Primary completion1 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Owens, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137327
- Sponsor's protocol ID
- 19-F-16
- Other IDs
- R324A190154
- Acronym
- CBS
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2021
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Outcomes of a Multi-Component, Individually-Tailored Consultation Process Focused on Classroom Management for Teachers
- ClinicalTrials.gov ID
- NCT05137327
- Acronym / sponsor ID
- CBS / 19-F-16
- Conditions
- ADHD
- Keywords
- inattention, disruptive behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Classroom Behavior Support (CBS) Condition | Experimental | Behavioral: Classroom Behavior Support (CBS) ConditionConsultants 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. |
| Standard Problem Solving Comparison Condition | Active comparator | Behavioral: Standard Problem Solving ConsultationConsultation 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- TEACHER: no exclusionary criteria.
- STUDENT: Special education eligibility of cognitive disability, autism, or multiple disability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classroom Behavior Support (CBS) ConditionAn 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. | Behavioural | Classroom Behavior Support (CBS) Condition |
| Standard Problem Solving ConsultationA standard problem solving approach to teacher consultation that includes observation and brief performance feedback. It represents current best practice in teacher consultation. | Behavioural | Standard Problem Solving Comparison Condition |
Primary outcome
Teacher Percent Appropriate Response to Rule Violation (ARRV) - Whole Class (Tier 1 Teacher Outcome)
Time frame: Growth from baseline through study completion, an average of 8 months
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.
Teacher Percent Appropriate Response to Rule Violation (ARRV) - Target Student (Tier 2 Teacher Outcome)
Time frame: Growth from baseline through study completion, an average of 6 months
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.
Whole Class Student Rule Violations (Tier 1 Student Outcome)
Time frame: Change from baseline through study completion, an average of 8 months
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.
Target Student Rule Violations (Tier 2 Student Outcome)
Time frame: Change from baseline through study completion, an average of 6 months
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.
11 secondary outcomes
Teacher Rate of Praise - Whole Class (Tier 1 Teacher Outcome)
Time frame: Change from baseline through study completion, an average of 8 months
Teacher Rate of Praise - Target Student (Tier 2 Teacher Outcome)
Time frame: Change from baseline through study completion, an average of 6 months
Teacher Rate of Opportunities to Respond (OTR) - Whole Class (Tier 1 Teacher Outcome)
Time frame: Change from baseline through study completion, an average of 8 months
Teacher Ratings of Target Student Academic Performance - (Tier 2 Student Outcome)
Time frame: Growth from baseline through study completion, an average of 6 months
Teacher Ratings of Target Student Behavior - (Tier 2 Student Outcome)
Time frame: Change from baseline through study completion, an average of 6 months
Parent Ratings of Target Student Behavior - (Tier 2 Student Outcome)
Time frame: Change from baseline to study completion, an average of 6 months
Teacher Ratings of Target Student ADHD Symptoms - (Tier 2 Student Outcome)
Time frame: Change from baseline to study completion, an average of 6 months
Parent Ratings of Target Student ADHD Symptoms - (Tier 2 Student Outcome)
Time frame: Change from baseline to study completion, an average of 6 months
Teacher Ratings of Positive and Problematic Student Behaviors - (Tier 2 Student Outcome)
Time frame: Change from baseline to study completion, an average of 6 months
Target Student Grade Point Average (GPA) Intervention Year - (Tier 2 Student Outcome)
Time frame: Growth from baseline to study completion, an average of 6 months
Target Student Grade Point Average (GPA) Long Term Follow Up - (Tier 2 Student Outcome)
Time frame: Growth from baseline to one year following study completion, an average of 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: Yes. 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.
Related trials for ADHD
Not yet recruitingObservational study
Phase 1: Thrive Together: A Feasibility and Acceptability Evaluation of Peer Mentoring for High Schoolers With ADHD and Their Caregivers
Attention-Deficit/Hyperactivity Disorder (ADHD)
RecruitingPhase 3
A Long-term Trial of EB-1020 in Adult Patients With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 2/3
Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 4
AWARE: Management of ADHD in Autism Spectrum Disorder
ADHD, Autism Spectrum Disorder
Active, not recruiting
Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity (ADHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classroom Behavior Support (CBS) Condition and Standard Problem Solving Consultation in people with ADHD, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Teacher Percent Appropriate Response to Rule Violation (ARRV) - Whole Class (Tier 1 Teacher Outcome) (time frame: Growth from baseline through study completion, an average of 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.