Attention Deficit Disorder With HyperactivityNCT00930449
Effects Of A Computerized Working Memory Training Program On Attention, Working Memory, And Academics, In Adolescents With Severe ADHD/LD
A study testing Cogmed Working Memory Training Program., Academy of Math and Special Education/Individualized Tutoring in people with Attention Deficit Disorder With Hyperactivity and Learning Disorders, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
Our primary aim is to determine whether a computerized working memory (WM) training program will help students with severe learning and attention problems, in terms of improving their WM. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Learning Disorders
- What is being tested?
- Cogmed Working Memory Training Program., Academy of Math and Special Education/Individualized Tutoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2008to Jan 2012
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- fulltime enrollment at one of the three English-language speaking OPDS schools
- confirmed diagnosis of a specific LD with or without comorbid ADHD
- IQ > 80 (based on WISC-IV)
- English as the primary spoken language
Who cannot join
- uncorrected sensory impairments (vision, hearing)
- severe comorbid mental health disorders requiring medications other than those used for ADHD or intensive treatment
- severe impairments in oral communication, impeding intelligibility of spoken responses
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Ontario Provincial and Demonstration Schools
Milton, Ontario
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Our primary aim is to determine whether a computerized working memory (WM) training program will help students with severe learning and attention problems, in terms of improving their WM. Additional aims are to determine whether the WM training will also result in improvements in the students' concentration and school work, and how long any beneficial effects will last (i.e., whether the students will continue to show improvements once the training program has stopped).
Read the detailed description
We have established a collaborative partnership between OISE, HSC, OPDS, and JVS to evaluate the effectiveness of a WM training program when conducted in a school setting. To determine whether the WM training program does improve WM, attention, behaviour, and/or academic achievement, we will compare its effects to those expected to result from two other intervention programs that focus on academic skills only: 1) a computerized software program known to improve math skills (Academy of Math®); and 2) extra, individualized tutoring in an area of academic weakness supervised by a trained and experienced staff person. We will assess WM, related cognitive abilities, ADHD symptoms, academic achievement, before and after intervention, and also at 3- and 6-month follow-up to determine whether any improvements are sustained and increased after the training has finished.
- Being tested
- Cogmed Working Memory Training Program., Academy of Math, Special Education/Individualized Tutoring
- Keywords
- Pediatrics, Attention-Deficit Hyperactivity Disorder, Learning Disorder, Computerized Working Memory Training Program
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogmed Working Memory Training Program.Other
This program includes a set of visual-spatial and auditory-verbal WM tasks presented via the computer (see Appendix 1 for a description of these tasks). All tasks involve: a) maintenance of simultaneous mental representations of multiple stimuli; b) unique sequencing of stimulus order in each trial; and c) progressive adaptation of difficulty level as a function of individual performance.
Training will require about 30 minutes per day, 5 days per week, for 5-6 weeks: participants are required to complete 90 WM trials on each training day. Training plans are individualized and are modified according to performance, but the typical plan includes 13 tasks, with 15 trials of 8 tasks each day.
Academy of MathOther
This is an established evidence-based program designed to help at-risk learners (Grades K-12) develop mathematical proficiency by incorporating a mastery-learning approach to foster conceptual understanding, computational fluency, and strategic competency across 10 mathematical subject areas.
Training is will require about 30 minutes, 5 days per week, for the same duration as the WM program (5-6 weeks), with a counselor or teacher acting as the training aide.
Special Education/Individualized TutoringOther
Students in this group will receive an additional 30 minutes daily of individualized supplemental instruction in their area of greatest academic need.
| Study group | Role | What they receive |
|---|---|---|
| Cogmed Working Memory Training Program | Experimental | Not described Receives: Other: Cogmed Working Memory Training Program. |
| Academy of Math® program | Active comparator | Not described Receives: Other: Academy of Math |
| Special Education/Individualized Tutoring | Active comparator | Not described Receives: Other: Special Education/Individualized Tutoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
CANTAB Spatial Working Memory
Measured: 15-20 min
Automated Working Memory Assessment Listening Recall
Measured: 15-20 min
Secondary outcomes (3)
Teacher - Strengths and Weakness of ADHD-symptoms and Normal-behavior scale (SWAN)
Measured: 5 min/student
Teacher - Children's Organizational Skills Scale
Measured: 5 min/student
Wide Range Achievement Test 4 Progress Monitoring Version: word reading, spelling, sentence comprehension, math computation
Measured: 10-15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startNov 2008
- Primary completionJan 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies 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
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Eastern Ontario
- Responsible party
- Principal investigator, Rosemary Tannock, The Hospital for Sick Children
- Investigators
- Rosemary Tannock, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930449
- Sponsor's protocol ID
- 1000013779
- Status last verified
- May 2015
- First submitted
- 29 Jun 2009
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of A Computerized Working Memory Training Program On Attention, Working Memory, And Academics, In Adolescents With Severe ADHD/LD
- ClinicalTrials.gov ID
- NCT00930449
- Acronym / sponsor ID
- 1000013779
- Keywords
- Pediatrics, Attention-Deficit Hyperactivity Disorder, Learning Disorder, Computerized Working Memory Training Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Children's Hospital of Eastern Ontario
- Study start
- Nov 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 30 Jun 2009 (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.
Our primary aim is to determine whether a computerized working memory (WM) training program will help students with severe learning and attention problems, in terms of improving their WM. Additional aims are to determine whether the WM training will also result in improvements in the students' concentration and school work, and how long any beneficial effects will last (i.e., whether the students will continue to show improvements once the training program has stopped).
Detailed description
We have established a collaborative partnership between OISE, HSC, OPDS, and JVS to evaluate the effectiveness of a WM training program when conducted in a school setting. To determine whether the WM training program does improve WM, attention, behaviour, and/or academic achievement, we will compare its effects to those expected to result from two other intervention programs that focus on academic skills only: 1) a computerized software program known to improve math skills (Academy of Math®); and 2) extra, individualized tutoring in an area of academic weakness supervised by a trained and experienced staff person. We will assess WM, related cognitive abilities, ADHD symptoms, academic achievement, before and after intervention, and also at 3- and 6-month follow-up to determine whether any improvements are sustained and increased after the training has finished.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cogmed Working Memory Training Program | Experimental | Other: Cogmed Working Memory Training Program. |
| Academy of Math® program | Active comparator | Other: Academy of Math |
| Special Education/Individualized Tutoring | Active comparator | Other: Special Education/Individualized Tutoring |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- fulltime enrollment at one of the three English-language speaking OPDS schools
- confirmed diagnosis of a specific LD with or without comorbid ADHD
- IQ > 80 (based on WISC-IV)
- English as the primary spoken language
Key exclusion criteria (3 listed)
- uncorrected sensory impairments (vision, hearing)
- severe comorbid mental health disorders requiring medications other than those used for ADHD or intensive treatment
- severe impairments in oral communication, impeding intelligibility of spoken responses
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 |
|---|---|---|
| Cogmed Working Memory Training Program.This program includes a set of visual-spatial and auditory-verbal WM tasks presented via the computer (see Appendix 1 for a description of these tasks). All tasks involve: a) maintenance of simultaneous mental representations of multiple stimuli; b) unique sequencing of stimulus order in each trial; and c) progressive adaptation of difficulty level as a function of individual performance. Training will require about 30 minutes per day, 5 days per week, for 5-6 weeks: participants are required to complete 90 WM trials on each training day. Training plans are individualized and are modified according to performance, but the typical plan includes 13 tasks, with 15 trials of 8 tasks each day. | Other | Cogmed Working Memory Training Program |
| Academy of MathThis is an established evidence-based program designed to help at-risk learners (Grades K-12) develop mathematical proficiency by incorporating a mastery-learning approach to foster conceptual understanding, computational fluency, and strategic competency across 10 mathematical subject areas. Training is will require about 30 minutes, 5 days per week, for the same duration as the WM program (5-6 weeks), with a counselor or teacher acting as the training aide. | Other | Academy of Math® program |
| Special Education/Individualized TutoringStudents in this group will receive an additional 30 minutes daily of individualized supplemental instruction in their area of greatest academic need. | Other | Special Education/Individualized Tutoring |
Primary outcome
CANTAB Spatial Working Memory
Time frame: 15-20 min
Automated Working Memory Assessment Listening Recall
Time frame: 15-20 min
3 secondary outcomes
Teacher - Strengths and Weakness of ADHD-symptoms and Normal-behavior scale (SWAN)
Time frame: 5 min/student
Teacher - Children's Organizational Skills Scale
Time frame: 5 min/student
Wide Range Achievement Test 4 Progress Monitoring Version: word reading, spelling, sentence comprehension, math computation
Time frame: 10-15 min
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 27 May 2015.
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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.
Rosemary Tannock, MD principal investigator
The Hospital for Sick Children, Toronto Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cogmed Working Memory Training Program., Academy of Math and Special Education/Individualized Tutoring in people with Attention Deficit Disorder With Hyperactivity and Learning Disorders, run by The Hospital for Sick Children at 2 sites 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 4 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
CANTAB Spatial Working Memory (time frame: 15-20 min). The study lists 2 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 27 May 2015.