Attention Deficit Hyperactivity DisorderPhase 4NCT00918567
Impact of Strattera and Behavior Therapy on the Home and School Functioning of Children With ADHD
A Phase 4 study testing atomoxetine and Behavior Modification Therapy in people with Attention Deficit Hyperactivity Disorder, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
Background: Multiple studies have found Atomoxetine (Strattera) to be efficacious but there is only one published study specifically designed to evaluate its efficacy in school settings. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- atomoxetine and Behavior Modification Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Sep 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- meet DSM-IV diagnostic criteria for ADHD-combined type;
- estimated IQ of 75 or higher;
- agree to comply with the randomly assigned treatment condition;
- enrolled in full time school at first grade level or higher; AND
- have a primary teacher available to complete ratings for the entire study duration.
Who cannot join
- current or past history of seizures (not including benign febrile seizures) or other neurological disorders;
- physical conditions that preclude administration of Strattera or other medical illness that might confound study results or increase the safety risk to subjects exposed to study treatments (i.e. marked cardiac conduction delay, etc.);
- prior failed trial of Strattera defined as 3 weeks or more on a daily dose of Strattera of at least .8mg/kg or a documented inability to tolerate at least .8mg/kg/day;
- serious forms of psychopathology other than ADHD, such autism, bipolar disorder, schizophrenia or any other psychopathology requiring urgent treatment with psychotropic medication; OR
- children for whom discontinuation of their current psychotropic medication would represent a serious risk to themselves or others.
- The presence of Oppositional Defiant Disorder (ODD), Conduct Disorder (CD) or learning disabilities will not result in exclusion from the study as they are commonly occurring comorbidities that have not been found to moderate response to ADHD treatments (Jensen et al., 2001). Enrollment in special education services will also not be an exclusionary criteria as work by this research group has found that such services do not affect response to ADHD treatments (Niemic, Fabiano, Pelham, \& Fuller, 2002).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cennter for Children and Families
Buffalo, New York, 14214
About this study
Official title: Effects of Strattera and Behavior Therapy on the School and Home Functioning of Elementary School Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Background: Multiple studies have found Atomoxetine (Strattera) to be efficacious but there is only one published study specifically designed to evaluate its efficacy in school settings. In this 7 week placebo-controlled study, Atomoxetine (ATX) at mean dose of 1.3 mg/kg, significantly reduced teacher rated ADHD symptoms (Weiss et al., 2005). However, children are typically referred for treatment because of "real life" problems in functioning, not symptoms (Pelham, Fabiano, \& Massetti, 2005). While ATX has been found to produce functional improvements at home, the Weiss study found limited results in this area at school.
Furthermore, almost no research has examined the effects of combining ATX and behavior therapy (BT). In the MTA, adding BT to stimulants improved teacher ratings of hyperactivity/impulsivity and increased the number of subjects reaching optimal response (Swanson et al., 2001). Therefore, it is possible that the addition of BT to ATX may improve functional performance in the classroom. The effects of combined therapy may be even larger for ATX as monotherapy with nonstimulants produces smaller effect sizes than with stimulants.
Objective: The primary objective was to evaluate the effects of ATX alone and in combination with BT on the school functioning of 56 children ages 6-12 with ADHD. Outcomes were assessed using traditional symptoms measures as well as functional measures of academic and behavioral improvements in the classroom.
Read the detailed description
The objectives were evaluated in an 8 week open label trial of where half of the participants were randomly assigned to receive (ATX+BT) while the rest received only ATX. An open label design was employed as the efficacy of ATX for ADHD symptoms has been established and to ensure that all patients received at least one active treatment. Parents in the ATX+BT group attended an eight week parenting course using the Community Oriented Parent Education (COPE) program (Cunningham, Bremner, \& Secord, 1998) while the child participated in an eight week social skills course. Teachers implemented a Daily Report Card (DRC) to track classroom behaviors. In the BT group, the child's DRC performance was communicated daily to parents and tied to consequences at home and school. In the ATX group, parents were not provided with the DRCs. The ATX dosing protocol was as follows: .5mg/kg per day on days 1-3, .8mg/kg/day days 4-7, 1.2mg/kg days 8+. After 3 weeks, subjects were eligible to increase to 1.8mg/kg/day. ATX was dosed once in the morning but could be dosed BID to address tolerability. The mean final dose was 1.4mg/kg/day.
To be enrolled, children must have had an IQ > 75, not failed a trial of ATX, met DSM criteria for ADHD but not other psychiatric comorbidities except ODD/CD and be in good physical health. Children already taking ADHD medication were enrolled only if the average symptom score on the ADHD subscale of the Disruptive Behaviors Disorders (DBD) scale was >2 (moderate impairment). ADHD was confirmed by parent report on the DISC and the DBD, which rates all DSM 3R and IV symptoms of ODD, CD and ODD on a 0-3 likert scale. Subjects were also required to evidence ADHD symptoms in the classroom as rated on the IOWA Conners. Psychiatric comorbidities were assessed using the DISC.
Measures of treatment response included:
- Parents and teacher ratings on the IOWA Conners: 10 item Likert ratings to measure children's inattention-overactive-impulsive and oppositional-defiant behavior (Milich, Loney, \& Landau, 1982)
- Parent and teacher ratings on the Impairment Rating Scale (IRS): 8 items using visual-analogue scales to measure children's functional impairment in peer relationships, adult-child relationships, academic performance, classroom behavior, and self esteem (Fabiano et al., 2006).
- Parent and teacher side effect ratings using a structured list of common side effects seen with ATX modeled after the Pittsburgh Side Effects Rating Scale (Pelham, 1993).
- Direct observations of subjects to measure rule violations and on/off task behavior using a modified version of the COCADD system (Atkins, Pelham \& Licht, 1988) in which trained observers watched children in their classroom for 30 minutes, recording each rule violation and off-task behavior.
- Parent and teacher rating on the Social Skills Rating Scale (SSRS): a measure of teachers' and parents perceptions of children's social and academic skills and of their overall problem behaviors (Gresham \& Elliott, 1990).
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- atomoxetine, Behavior Modification Therapy
- Keywords
- ADHD, Atomoxetine, Behavior Therapy
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atomoxetineDrug
Also called Drug Therapy
open label treatment dosed up to 1.8mg/kg/day
Behavior Modification TherapyBehavioural
Also called Behavior Therapy
8 week behavioral modification course with school consultation, parenting groups using COPE and child social skills group
| Study group | Role | What they receive |
|---|---|---|
| Combined therapy | Experimental | atomoxetine plus behavior therapy Receives: Drug: atomoxetine; Behavioral: Behavior Modification Therapy |
| Drug therapy | Active comparator | atomoxetine alone Receives: Drug: atomoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rule Violations During Direct Classroom Observation at Endpoint (Week 8)
Observations were conducted using the Student Behavior Teacher Response Observation Code. After learning the classroom rules, observers watched children in their classrooms for 30 minutes during an academic activity and recorded each time the subject violated a classroom rule. Total classroom rule violations were used as the primary outcome measures for the study.
Measured: Endpoint (Week 8)
Secondary outcomes (10)
Impairment Rating Scale (Parent Completed) at Endpoint
The IRS is a 8 item measure that uses visual-analogue scales to evaluate the child's problem level and need for treatment in developmentally important areas, such as peer relationships, adult-child relationships, academic performance, and classroom behavior 51. The scale is scored from 0 (no problem) to 6 (extreme problem). The scale has excellent test-retest and inter-rater reliability and well supported validity 51, 52.
Measured: Endpoint (Week 8)
Impairment Rating Scale (Teachers) at Endpoint
The IRS is a 6 item measure that uses visual-analogue scales to evaluate the child's problem level and need for treatment in developmentally important areas, such as peer relationships, adult-child relationships, academic performance, and classroom behavior. The scale is scored from 0 (no problem) to 6 (extreme problem). The scale has excellent test-retest and inter-rater reliability and well supported validity.
Measured: Endpoint (Week 8)
Pittsburgh Side Effects Rating Scale (PSERS)(Parent Completed) at Endpoint:
The PSERS measures adverse events commonly associated with stimulant medication and has been used in multiple studies of ADHD. For this study, the PSERS was modified to also assess adverse emotional events potentially associated with ATX, including suicidal statements. The resulting scale consisted of 14 items (an additional sleep item for parents) rated from 0 ("none") to 3 ("severe"). An overall side effects score was computed by averaging across all ratings and used in analyses.
Measured: Endpoint (Week 8)
Pittsburgh Side Effects Rating Scale (PSERS)(Teacher Rated):
The PSERS measures adverse events commonly associated with stimulant medication and has been used in multiple studies of ADHD. For this study, the PSERS was modified to also assess adverse emotional events potentially associated with ATX, including suicidal statements. The resulting scale consisted of 13 items (for teachers) rated from 0 ("none") to 3 ("severe"). An overall side effects score was computed by averaging across all ratings and used in analyses.
Measured: at weeks 8 (Endpoint)
Disruptive Behavior Disorders Rating Scale ODD Subscale (DBD- Parent Completed) at Endpoint
The DBD consists of 8 items that are the DSM-IV symptoms of Oppositional Defiant Disorder (ODD). Items on the DBD were rated by parents and teachers using Likert scales that ranged from 0 ("not at all") to 3 ("very much"). The factor structure, reliability and validity of the DBD have been supported in multiple studies.
Measured: Endpoint (Week 8)
Disruptive Behavior Disorder Rating Scale ODD Subscale(DBD- Teacher Completed) at Endpoint
The DBD consists of 8 items that are the DSM-IV symptoms of Oppositional Defiant Disorder (ODD). Items on the DBD were rated by parents and teachers using Likert scales that ranged from 0 ("not at all") to 3 ("very much"). The factor structure, reliability and validity of the DBD have been supported in multiple studies.
Measured: Endpoint (Week 8)
Social Skills Rating Scale Problem Behavior Subscale(SSRS Parent) at Endpoint
completed by parents to measure children's problem behaviors (PB). Items are rated from 0 ("not at all") to 2 ("very often"). The scale has 55 items. The score reported below is the sum total of the items on the scale and then averaged for the whole group. Therefore, the range can be between 0 and 110. A higher score indicates a better outcome.
Measured: Endpoint (Week 8)
Social Skills Rating Scale Problem Behavior Subscale(SSRS Teachers) at Endpoint
The SSRS was completed by teachers to measure children's problem behaviors (PB). Items are rated from 0 ("not at all") to 2 ("very often"). The scale has 55 items. The score reported below is the sum total of the items on the scale and then averaged for the whole group. Therefore, the range can be between 0 and 110. A higher score indicates a better outcome.
Measured: Endpoint (Week 8)
ADHD Subscale of the DBD (Parent Completed) at Endpoint
The DBD consists of 18 items that are the DSM-IV symptoms of ADHD. Items on the DBD were rated by parents and teachers using Likert scales that ranged from 0 ("not at all") to 3 ("very much"). The factor structure, reliability and validity of the DBD have been supported in multiple studies.
Measured: Endpoint (Week 8)
ADHD Subscale of the DBD (Teacher Completed) at Endpoint
The ADHD subscale of the DBD consists of 18 items that are the DSM-IV symptoms of ADHD. Items on the DBD were rated by parents and teachers using Likert scales that ranged from 0 ("not at all") to 3 ("very much"). The factor structure, reliability and validity of the DBD have been supported in multiple studies.
Measured: Endpoint (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, James Waxmonsky, State University of New York at Buffalo
- Investigators
- James G Waxmonsky, Principal investigator, SUNY BuffaloDaniel A Waschbusch, Principal investigator, SUNY Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918567
- Sponsor's protocol ID
- B4Z-US-X053
- Status last verified
- Oct 2020
- First submitted
- 9 Jun 2009
- Last updated
- 20 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Waxmonsky JG, Waschbusch DA, Pelham WE, Draganac-Cardona L, Rotella B, Ryan L. Effects of atomoxetine with and without behavior therapy on the school and home functioning of children with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2010 Nov;71(11):1535-51. doi: 10.4088/JCP.09m05496pur. Epub 2010 Jun 29.
PubMed 20673557
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Strattera and Behavior Therapy on the School and Home Functioning of Elementary School Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00918567
- Acronym / sponsor ID
- B4Z-US-X053
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Atomoxetine, Behavior Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Multiple studies have found Atomoxetine (Strattera) to be efficacious but there is only one published study specifically designed to evaluate its efficacy in school settings. In this 7 week placebo-controlled study, Atomoxetine (ATX) at mean dose of 1.3 mg/kg, significantly reduced teacher rated ADHD symptoms (Weiss et al., 2005). However, children are typically referred for treatment because of "real life" problems in functioning, not symptoms (Pelham, Fabiano, \& Massetti, 2005). While ATX has been found to produce functional improvements at home, the Weiss study found limited results in this area at school.
Furthermore, almost no research has examined the effects of combining ATX and behavior therapy (BT). In the MTA, adding BT to stimulants improved teacher ratings of hyperactivity/impulsivity and increased the number of subjects reaching optimal response (Swanson et al., 2001). Therefore, it is possible that the addition of BT to ATX may improve functional performance in the classroom. The effects of combined therapy may be even larger for ATX as monotherapy with nonstimulants produces smaller effect sizes than with stimulants.
Objective: The primary objective was to evaluate the effects of ATX alone and in combination with BT on the school functioning of 56 children ages 6-12 with ADHD. Outcomes were assessed using traditional symptoms measures as well as functional measures of academic and behavioral improvements in the classroom.
Detailed description
The objectives were evaluated in an 8 week open label trial of where half of the participants were randomly assigned to receive (ATX+BT) while the rest received only ATX. An open label design was employed as the efficacy of ATX for ADHD symptoms has been established and to ensure that all patients received at least one active treatment. Parents in the ATX+BT group attended an eight week parenting course using the Community Oriented Parent Education (COPE) program (Cunningham, Bremner, \& Secord, 1998) while the child participated in an eight week social skills course. Teachers implemented a Daily Report Card (DRC) to track classroom behaviors. In the BT group, the child's DRC performance was communicated daily to parents and tied to consequences at home and school. In the ATX group, parents were not provided with the DRCs. The ATX dosing protocol was as follows: .5mg/kg per day on days 1-3, .8mg/kg/day days 4-7, 1.2mg/kg days 8+. After 3 weeks, subjects were eligible to increase to 1.8mg/kg/day. ATX was dosed once in the morning but could be dosed BID to address tolerability. The mean final dose was 1.4mg/kg/day.
To be enrolled, children must have had an IQ > 75, not failed a trial of ATX, met DSM criteria for ADHD but not other psychiatric comorbidities except ODD/CD and be in good physical health. Children already taking ADHD medication were enrolled only if the average symptom score on the ADHD subscale of the Disruptive Behaviors Disorders (DBD) scale was >2 (moderate impairment). ADHD was confirmed by parent report on the DISC and the DBD, which rates all DSM 3R and IV symptoms of ODD, CD and ODD on a 0-3 likert scale. Subjects were also required to evidence ADHD symptoms in the classroom as rated on the IOWA Conners. Psychiatric comorbidities were assessed using the DISC.
Measures of treatment response included:
- Parents and teacher ratings on the IOWA Conners: 10 item Likert ratings to measure children's inattention-overactive-impulsive and oppositional-defiant behavior (Milich, Loney, \& Landau, 1982)
- Parent and teacher ratings on the Impairment Rating Scale (IRS): 8 items using visual-analogue scales to measure children's functional impairment in peer relationships, adult-child relationships, academic performance, classroom behavior, and self esteem (Fabiano et al., 2006).
- Parent and teacher side effect ratings using a structured list of common side effects seen with ATX modeled after the Pittsburgh Side Effects Rating Scale (Pelham, 1993).
- Direct observations of subjects to measure rule violations and on/off task behavior using a modified version of the COCADD system (Atkins, Pelham \& Licht, 1988) in which trained observers watched children in their classroom for 30 minutes, recording each rule violation and off-task behavior.
- Parent and teacher rating on the Social Skills Rating Scale (SSRS): a measure of teachers' and parents perceptions of children's social and academic skills and of their overall problem behaviors (Gresham \& Elliott, 1990).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined therapy | Experimental | Drug: atomoxetine, Behavioral: Behavior Modification Therapyatomoxetine plus behavior therapy |
| Drug therapy | Active comparator | Drug: atomoxetineatomoxetine alone |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- meet DSM-IV diagnostic criteria for ADHD-combined type;
- estimated IQ of 75 or higher;
- agree to comply with the randomly assigned treatment condition;
- enrolled in full time school at first grade level or higher; AND
- have a primary teacher available to complete ratings for the entire study duration.
Key exclusion criteria (6 listed)
- current or past history of seizures (not including benign febrile seizures) or other neurological disorders;
- physical conditions that preclude administration of Strattera or other medical illness that might confound study results or increase the safety risk to subjects exposed to study treatments (i.e. marked cardiac conduction delay, etc.);
- prior failed trial of Strattera defined as 3 weeks or more on a daily dose of Strattera of at least .8mg/kg or a documented inability to tolerate at least .8mg/kg/day;
- serious forms of psychopathology other than ADHD, such autism, bipolar disorder, schizophrenia or any other psychopathology requiring urgent treatment with psychotropic medication; OR
- children for whom discontinuation of their current psychotropic medication would represent a serious risk to themselves or others.
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 |
|---|---|---|
| atomoxetineAlso: Drug Therapyopen label treatment dosed up to 1.8mg/kg/day | Drug | Combined therapy, Drug therapy |
| Behavior Modification TherapyAlso: Behavior Therapy8 week behavioral modification course with school consultation, parenting groups using COPE and child social skills group | Behavioural | Combined therapy |
Primary outcome
Rule Violations During Direct Classroom Observation at Endpoint (Week 8)
Time frame: Endpoint (Week 8)
Observations were conducted using the Student Behavior Teacher Response Observation Code. After learning the classroom rules, observers watched children in their classrooms for 30 minutes during an academic activity and recorded each time the subject violated a classroom rule. Total classroom rule violations were used as the primary outcome measures for the study.
10 secondary outcomes
Impairment Rating Scale (Parent Completed) at Endpoint
Time frame: Endpoint (Week 8)
Impairment Rating Scale (Teachers) at Endpoint
Time frame: Endpoint (Week 8)
Pittsburgh Side Effects Rating Scale (PSERS)(Parent Completed) at Endpoint:
Time frame: Endpoint (Week 8)
Pittsburgh Side Effects Rating Scale (PSERS)(Teacher Rated):
Time frame: at weeks 8 (Endpoint)
Disruptive Behavior Disorders Rating Scale ODD Subscale (DBD- Parent Completed) at Endpoint
Time frame: Endpoint (Week 8)
Disruptive Behavior Disorder Rating Scale ODD Subscale(DBD- Teacher Completed) at Endpoint
Time frame: Endpoint (Week 8)
Social Skills Rating Scale Problem Behavior Subscale(SSRS Parent) at Endpoint
Time frame: Endpoint (Week 8)
Social Skills Rating Scale Problem Behavior Subscale(SSRS Teachers) at Endpoint
Time frame: Endpoint (Week 8)
ADHD Subscale of the DBD (Parent Completed) at Endpoint
Time frame: Endpoint (Week 8)
ADHD Subscale of the DBD (Teacher Completed) at Endpoint
Time frame: Endpoint (Week 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20673557Waxmonsky JG, Waschbusch DA, Pelham WE, Draganac-Cardona L, Rotella B, Ryan L. Effects of atomoxetine with and without behavior therapy on the school and home functioning of children with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2010 Nov;71(11):1535-51. doi: 10.4088/JCP.09m05496pur. Epub 2010 Jun 29.
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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.
James G Waxmonsky principal investigator
SUNY Buffalo
Daniel A Waschbusch principal investigator
SUNY Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing atomoxetine and Behavior Modification Therapy in people with Attention Deficit Hyperactivity Disorder, run by State University of New York at Buffalo 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 5 inclusion and 6 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 20 Oct 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rule Violations During Direct Classroom Observation at Endpoint (Week 8) (time frame: Endpoint (Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00918567, which also lists 1 linked publication.
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 20 Oct 2020.