Attention Deficit Hyperactivity Disorder (ADHD)Phase 2NCT01547702
Classroom-based Distance Intervention for Teachers of Children With Attention Deficit Hyperactivity Disorder
A Phase 2 study testing Teacher Help for ADHD in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Dalhousie University at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate, by way of randomized controlled trial, the effectiveness of a web-based, time-flexible, and teacher-directed "Teacher Help for ADHD" program in reducing the impact of ADHD symptoms in elementary students. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Teacher Help for ADHD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to May 2013
- Phase
- Phase 2
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Student is in grades 1 to 6 in the public school English stream
- Student has been formally diagnosed with Attention Deficit Hyperactivity Disorder having a diagnosis of ADHD
- Student is either on a stable dose of medication or no medication with no plan to start/change medication in the next 5 months
Who cannot join
- Student has a significant other mental health issue (e.g., depression, anxiety, suicidal ideation, psychotic features, and severe conduct problems)
- Student is on an Individualized Program Plan (IPP) due to significant physical, behavioural, communication, or learning difficulties.
- Teacher participated in the Teacher Help for ADHD pilot study (conducted by Brittany Barnett, Master of Health Informatics Student under the supervision of Dr. Elik and Dr. Corkum, Dalhousie University)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized-controlled Trial of a Classroom-based Distance Intervention for Teachers of Elementary School-aged Children With ADHD
The purpose of this study is to evaluate, by way of randomized controlled trial, the effectiveness of a web-based, time-flexible, and teacher-directed "Teacher Help for ADHD" program in reducing the impact of ADHD symptoms in elementary students.
Read the detailed description
*Please note that the information below is taken verbatim from our project's research summary.*
Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most well-researched areas in childhood psychopathology. ADHD is a highly prevalent (5% of school-aged children) and chronic disorder (ADHD will persist into adulthood for ~70% of children diagnosed with this disorder). ADHD has a substantial impact on daily life including difficulties with behavioural, academic, social and emotional functioning (DuPaul \& Weyandt, 2006).
Although medication is the most commonly used treatment, there are a number of important limitations including poor long-term effects, lack of effectiveness in improving academic skills, and lack of acceptability by parents and children (DuPaul, 2007). Therefore, a number of psychosocial interventions have been developed and empirically validated (parent training, social skills training, school-based interventions). School-based interventions have been shown to be effective; however, these are significantly underutilized and when implemented in an uncontrolled way, are often ineffective. This intervention program is comprised of evidence-based treatment strategies that are presented in a manner that will provide teachers with knowledge of the disorder and intervention strategies. The novel delivery of this program, through distance treatment modalities (e-mail and internet) will allow us to overcome many of the known barriers to treatment so that teachers will receive the necessary information in a timely and efficient manner. The specific research questions that will be addressed are:
- Does the overall impairment of children with ADHD in the treatment group improve compared to those who are in the waitlist group?
- Is the school-based intervention effective in reducing ADHD symptoms, improving behavioral functioning, and enhancing academic performance in the active treatment group compared to the waitlist group?
- Do teachers in the treatment group develop more knowledge about ADHD and more positive and realistic attitudes about this disorder over the course of the intervention?
- Is the intervention viewed as accessible to teachers and is there evidence of fidelity to the program?
The investigators expect that the program will reduce overall impairment, improve ADHD symptoms, behavioural, and academic functioning in the children and will enhance knowledge and reduce misconceptions of ADHD in teachers. If successful, this program will be disseminated to school boards in Nova Scotia and across Canada, and as such would have the potential to have a significant positive effect on the health and well-being of many children, teachers and parents.
- Being tested
- Teacher Help for ADHD
- Keywords
- ADHD, attention, inattention, hyperactivity, classroom intervention, teacher education, web-based intervention
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teacher Help for ADHDBehavioural
Teachers will review powerpoints other materials online and will have access to a study coach to assist with their understanding and practical application of the materials. Session descriptions follow:
- Session 1: Provide information about ADHD characteristics, impact, diagnosis, etiology
- Session 2: Help establish teacher's role; goal setting; introduce behaviour planning
- Session 3: Help develop and implement behaviour program specific to the needs of students with Session 2 goals
- Session 4: Help develop strategies re: classroom structure, work assignments, teacher-student relationship
- Session 5: Help to use instructional interventions for ADHD
- Session 6: Help to teach these students self-monitoring and self-evaluation skills; help teachers to evaluate progress, phase out behaviour program, and plan for relapses in unwanted behaviours
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | This group will have access to the Teacher Help for ADHD intervention program during the randomized controlled trial. Receives: Behavioral: Teacher Help for ADHD |
| Waitlist Control | No intervention | This group will not receive the intervention until all data collection is complete for their study cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Impairment Rating Scale (IRS, Fabiano & Pelham, 2002)
The IRS will be the primary outcome measure in our study because it assesses the areas of functioning that are impacted most by the symptoms of ADHD. It consists of six questions on the teacher version and seven questions on the parent version, which measure the child's academic, behavioural, relational functioning and self-esteem.
Measured: Change from Baseline in ADHD symptom impairment at 6 weeks (length of intervention) and 12 weeks (follow-up)
Secondary outcomes (10)
Knowledge of Attention Deficit Disorder Scale (KADDS; Sciutto, Terjesen, & Bender, 2000)
The KADDS is 36-item True/False questionnaire used to evaluate parents' and teachers' ADHD knowledge. Parents will complete this only at baseline, while teachers will be asked to complete it during baseline, end of trial, and follow up data collection periods.
Measured: Change from Baseline in ADHD knowledge at 6 weeks (length of intervention) and 12 weeks (follow-up)
Beliefs about Attention Deficit Hyperactivity Disorder (Kos, 2008)
This is a 31-item scale used to evaluated attitudes and beliefs about ADHD. Parents/teachers are asked to indicate on a 5-point scale (ranging from Strongly Agree to Strongly Disagree) how much they agree with various statements about ADHD. Parents will complete this only at baseline, while teachers will be asked to complete it during baseline, end of trial, and follow up data collection periods.
Measured: Change from Baseline in ADHD beliefs at 6 weeks (length of intervention) and 12 weeks (follow-up)
Instructional and Behavior Management Approaches Survey (IBMA; Martinussen, Tannock, & Chaban, 2011)
The IBMA is a 40-item scale used to evaluate teacher's classroom management practices. Teachers are asked to indicate on a 5-point scale (ranging from Rarely to Most of the time) how often they use the listed behavioural strategies.
Measured: Change from Baseline in behaviour management approaches at 6 weeks (length of intervention) and 12 weeks (follow-up)
Intention and Subjective Norm questionnaires (Based on Prochaska & DiClemente's Stages of Change Model, 1984)
These brief questionnaires contain 5 items in total and are used to evaluate teachers' intention to change and external sources of motivation as related to learning more about ADHD.
Measured: Change from Baseline in intentions and subjective norms at 6 weeks (length of intervention) and 12 weeks (follow-up)
Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP; see Murray, Bussing, Fernandez, Hou, Garvan, Swanson, & Eyberg, 2009)
The SKAMP is a 10-item questionnaire that measures the functional impairment of ADHD symptoms in the school setting. Statements target children's classroom attention and deportment, and teachers are asked to respond on a 4-point Likert-type scale, response items ranging from "Not at All" to "Very much."
Measured: Functional impairment of ADHD symptoms will be measured in the Treatment group at 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, and 7 weeks
Homework Problem Checklist (HPC; Anesko, Schoiock, Ramirez, & Levine, 1987)
The HPC is a parent report instrument consisting of 20 items. It has been used in a number of studies as a screening tool and outcome measure to assess homework problems.
Measured: Change from Baseline in homework problems at 6 weeks (length of program) and 12 weeks (follow-up)
Parent and Teacher Satisfaction Ratings (adapted from Ervin, DuPaul, Kern, & Friman, 1998)
Two versions of this questionnaire are used to assess parent and teacher satisfaction with interventions for children with ADHD. The parent version consists of 10 items and the teacher version consists of 15 items, rated on an 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). Items focused on intervention effectiveness (e.g., ''problem behavior improved during the intervention''), feasibility (e.g., ''the intervention was easy to implement''), and social validity (e.g., ''the student seemed to appreciate the intervention'').
Measured: Treatment group will complete satisfaction questionnaires at 6 weeks
Conners 3rd Edition Parent and Teacher Rating Scales (Full-length) (Conners 3-P, Conners 3-T; Conners, 2008)
The Conners 3-P and Conners 3-T are a 110-item and 115-item behavior rating scale designed to evaluate problem behaviors in the home and school settings in children aged 6 to 18 years.. These measures are the most widely used measures of ADHD symptoms in treatment trials. These measures will be accessed through a secure web link.
Measured: Change from Baseline in problem behaviours at 6 weeks (length of program) and 12 weeks (follow-up)
Home & School Situations Questionnaire (HSQ/SSQ; Barkley & Murphy, 2005)
The HSQ and SSQ evaluate the pervasiveness of children's behaviour problems in the home and school setting. Parents/Teachers are asked to rate their child's/student's behaviour problems across 16 different home/school situations using a 9-point Likert scale (1=mild to 9=severe).
Measured: Change from Baseline in behaviours at 6 weeks (length of program) and 12 weeks (follow-up)
Academic Performance Rating Scale (APRS; DuPaul, Rapport, & Perriello, 1991)
The APRS is a 19-item questionnaire that measures academic accuracy and productivity in the classroom. Factor analysis resulted in four scales (Total score, Academic Success, Impulse Control, and Academic Productivity). All scales will be used in this study.
Measured: Change from Baseline in academic performance at 6 weeks (length of program) and 12 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Penny V Corkum, PhD, Principal investigator, Dalhousie UniversityNezihe Elik, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547702
- Sponsor's protocol ID
- NSHRF-44576
- Status last verified
- Mar 2014
- First submitted
- 27 Feb 2012
- Last updated
- 28 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized-controlled Trial of a Classroom-based Distance Intervention for Teachers of Elementary School-aged Children With ADHD
- ClinicalTrials.gov ID
- NCT01547702
- Acronym / sponsor ID
- NSHRF-44576
- Keywords
- ADHD, attention, inattention, hyperactivity, classroom intervention, teacher education, web-based intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Mar 2012 (estimated)
- 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 purpose of this study is to evaluate, by way of randomized controlled trial, the effectiveness of a web-based, time-flexible, and teacher-directed "Teacher Help for ADHD" program in reducing the impact of ADHD symptoms in elementary students.
Detailed description
*Please note that the information below is taken verbatim from our project's research summary.*
Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most well-researched areas in childhood psychopathology. ADHD is a highly prevalent (5% of school-aged children) and chronic disorder (ADHD will persist into adulthood for ~70% of children diagnosed with this disorder). ADHD has a substantial impact on daily life including difficulties with behavioural, academic, social and emotional functioning (DuPaul \& Weyandt, 2006).
Although medication is the most commonly used treatment, there are a number of important limitations including poor long-term effects, lack of effectiveness in improving academic skills, and lack of acceptability by parents and children (DuPaul, 2007). Therefore, a number of psychosocial interventions have been developed and empirically validated (parent training, social skills training, school-based interventions). School-based interventions have been shown to be effective; however, these are significantly underutilized and when implemented in an uncontrolled way, are often ineffective. This intervention program is comprised of evidence-based treatment strategies that are presented in a manner that will provide teachers with knowledge of the disorder and intervention strategies. The novel delivery of this program, through distance treatment modalities (e-mail and internet) will allow us to overcome many of the known barriers to treatment so that teachers will receive the necessary information in a timely and efficient manner. The specific research questions that will be addressed are:
- Does the overall impairment of children with ADHD in the treatment group improve compared to those who are in the waitlist group?
- Is the school-based intervention effective in reducing ADHD symptoms, improving behavioral functioning, and enhancing academic performance in the active treatment group compared to the waitlist group?
- Do teachers in the treatment group develop more knowledge about ADHD and more positive and realistic attitudes about this disorder over the course of the intervention?
- Is the intervention viewed as accessible to teachers and is there evidence of fidelity to the program?
The investigators expect that the program will reduce overall impairment, improve ADHD symptoms, behavioural, and academic functioning in the children and will enhance knowledge and reduce misconceptions of ADHD in teachers. If successful, this program will be disseminated to school boards in Nova Scotia and across Canada, and as such would have the potential to have a significant positive effect on the health and well-being of many children, teachers and parents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Teacher Help for ADHDThis group will have access to the Teacher Help for ADHD intervention program during the randomized controlled trial. |
| Waitlist Control | No intervention | –This group will not receive the intervention until all data collection is complete for their study cohort. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Student is in grades 1 to 6 in the public school English stream
- Student has been formally diagnosed with Attention Deficit Hyperactivity Disorder having a diagnosis of ADHD
- Student is either on a stable dose of medication or no medication with no plan to start/change medication in the next 5 months
Key exclusion criteria (3 listed)
- Student has a significant other mental health issue (e.g., depression, anxiety, suicidal ideation, psychotic features, and severe conduct problems)
- Student is on an Individualized Program Plan (IPP) due to significant physical, behavioural, communication, or learning difficulties.
- Teacher participated in the Teacher Help for ADHD pilot study (conducted by Brittany Barnett, Master of Health Informatics Student under the supervision of Dr. Elik and Dr. Corkum, Dalhousie University)
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 |
|---|---|---|
| Teacher Help for ADHDTeachers will review powerpoints other materials online and will have access to a study coach to assist with their understanding and practical application of the materials. Session descriptions follow: * Session 1: Provide information about ADHD characteristics, impact, diagnosis, etiology * Session 2: Help establish teacher's role; goal setting; introduce behaviour planning * Session 3: Help develop and implement behaviour program specific to the needs of students with Session 2 goals * Session 4: Help develop strategies re: classroom structure, work assignments, teacher-student relationship * Session 5: Help to use instructional interventions for ADHD * Session 6: Help to teach these students self-monitoring and self-evaluation skills; help teachers to evaluate progress, phase out behaviour program, and plan for relapses in unwanted behaviours | Behavioural | Treatment |
Primary outcome
The Impairment Rating Scale (IRS, Fabiano & Pelham, 2002)
Time frame: Change from Baseline in ADHD symptom impairment at 6 weeks (length of intervention) and 12 weeks (follow-up)
The IRS will be the primary outcome measure in our study because it assesses the areas of functioning that are impacted most by the symptoms of ADHD. It consists of six questions on the teacher version and seven questions on the parent version, which measure the child's academic, behavioural, relational functioning and self-esteem.
10 secondary outcomes
Knowledge of Attention Deficit Disorder Scale (KADDS; Sciutto, Terjesen, & Bender, 2000)
Time frame: Change from Baseline in ADHD knowledge at 6 weeks (length of intervention) and 12 weeks (follow-up)
Beliefs about Attention Deficit Hyperactivity Disorder (Kos, 2008)
Time frame: Change from Baseline in ADHD beliefs at 6 weeks (length of intervention) and 12 weeks (follow-up)
Instructional and Behavior Management Approaches Survey (IBMA; Martinussen, Tannock, & Chaban, 2011)
Time frame: Change from Baseline in behaviour management approaches at 6 weeks (length of intervention) and 12 weeks (follow-up)
Intention and Subjective Norm questionnaires (Based on Prochaska & DiClemente's Stages of Change Model, 1984)
Time frame: Change from Baseline in intentions and subjective norms at 6 weeks (length of intervention) and 12 weeks (follow-up)
Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP; see Murray, Bussing, Fernandez, Hou, Garvan, Swanson, & Eyberg, 2009)
Time frame: Functional impairment of ADHD symptoms will be measured in the Treatment group at 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, and 7 weeks
Homework Problem Checklist (HPC; Anesko, Schoiock, Ramirez, & Levine, 1987)
Time frame: Change from Baseline in homework problems at 6 weeks (length of program) and 12 weeks (follow-up)
Parent and Teacher Satisfaction Ratings (adapted from Ervin, DuPaul, Kern, & Friman, 1998)
Time frame: Treatment group will complete satisfaction questionnaires at 6 weeks
Conners 3rd Edition Parent and Teacher Rating Scales (Full-length) (Conners 3-P, Conners 3-T; Conners, 2008)
Time frame: Change from Baseline in problem behaviours at 6 weeks (length of program) and 12 weeks (follow-up)
Home & School Situations Questionnaire (HSQ/SSQ; Barkley & Murphy, 2005)
Time frame: Change from Baseline in behaviours at 6 weeks (length of program) and 12 weeks (follow-up)
Academic Performance Rating Scale (APRS; DuPaul, Rapport, & Perriello, 1991)
Time frame: Change from Baseline in academic performance at 6 weeks (length of program) and 12 weeks (follow-up)
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 28 Mar 2014.
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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.
Penny V Corkum, PhD principal investigator
Dalhousie University
Nezihe Elik, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teacher Help for ADHD in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Dalhousie University at 1 site in Canada.
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 3 inclusion and 3 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 28 Mar 2014. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The Impairment Rating Scale (IRS, Fabiano & Pelham, 2002) (time frame: Change from Baseline in ADHD symptom impairment at 6 weeks (length of intervention) and 12 weeks (follow-up)). 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 28 Mar 2014.