Attention-Deficit Hyperactivity DisorderPhase 1NCT01657721
Working Memory Training in ADHD (The Engage Study)
A Phase 1 study testing Cogmed Working Memory Training Program in people with Attention-Deficit Hyperactivity Disorder, run by University of Toronto at 1 site in Canada.
Trial summary
The overall objective of the current study is to determine whether computerized Working Memory (WM) training will enhance WM capacity in college students with Attention Deficit Hyperactivity Disorder (ADHD). There are also four additional objectives. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention-Deficit Hyperactivity Disorder
- What is being tested?
- Cogmed Working Memory Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Sep 2014
- Phase
- Phase 1
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Formal diagnosis of ADHD by a doctor or psychologist
- Registered as a student at a post-secondary institution
- Registered with Student Disability/Accessibility Services at post-secondary institution
Who cannot join
- Major neurological dysfunction and psychosis
- Current use of sedating or mood altering medication other than stimulants provided for ADHD
- Motor or perceptual handicap that would prevent using the computer program.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Ontario Institute of Studies in Education (OISE) at The University of Toronto
Toronto, Ontario, M5S1V6
Rosemary Tannock, Ph.D.
About this study
Official title: Working Memory Training in Attention-Deficit/Hyperactivity Disorder: Neural Mechanisms of Change
The overall objective of the current study is to determine whether computerized Working Memory (WM) training will enhance WM capacity in college students with Attention Deficit Hyperactivity Disorder (ADHD). There are also four additional objectives. The first is to investigate whether the program's efficacy is impacted by the duration of the daily training sessions. The second is to determine whether improvements in WM will generalize to secondary outcome tasks, such as inhibitory control and planning. The third objective is to examine whether WM training will also ameliorate ADHD symptoms of inattention and hyperactivity. The last objective is to investigate whether improvements will be maintained at a two month follow-up period. The investigators will also be assessing healthy control participants,who will not be receiving treatment, but will be used as a basis of comparison with the ADHD participants,
It is expected that the computerized WM training program will enhance WM capacity in college students with ADHD. In addition, it is believed that these increases in WM capacity will also lead to improvements in other executive functions. It is also hypothesized that WM training will lead to a reduction in ADHD symptomology. Lastly, these improvements should be maintained at three month follow-up.
Read the detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) and Learning Disability (LD) are among the most common neurobehavioural disorders, with prevalence rates estimated at about 5% to 9% . Approximately 4% of youth in the United States have a comorbid diagnosis of ADHD and a Learning Disability (ADHD/LD). Research has shown ADHD/LD symptoms persist into young adulthood, a time when many are enrolled in post-secondary education. Students with ADHD/LD at the post-secondary education level constitute an emergent subgroup of the ADHD and LD populations that have received far less attention in the literature compared to children, adolescents and employed adults. The actual percentage of college students with ADHD/LD is unknown; however, some estimates suggest that 2-8% of students attending post secondary education have ADHD, LD or both. Youth with the additive problems of both disorders are at high risk for academic failure, and poor psychosocial and occupational outcomes in adulthood. The "multiple deficit model" suggests that there is a common genetic and neuropsychological underpinning to these disorders. For example, ADHD and LD share similar features, such as core deficits in processing speed and working memory. ADHD and LD are each associated with several cognitive difficulties including poor working memory (WM) and processing speed. WM is a "mental workspace" that provides temporary storage and manipulation of information and is closely related to g, a proposed measure of general cognitive ability. In addition, WM has also been found to predict academic achievement. One major problem is that current intervention approaches for ADHD/LD do not target the underlying cognitive deficits fundamental to these diagnoses. Thus, interventions that address underlying cognitive difficulties, such as WM, are a promising avenue of additional treatment for youth with combined ADHD/LD.
WM capacity has generally been thought to be a fixed trait, but recent studies have suggested that it can be improved by intensive and adaptive computerized training. This intervention approach has been evaluated in children and adolescents with ADHD, older adults, and adult stroke patients and shown promising results. Subjects not only improved on the trained WM tasks, but some of the studies suggest that improvements may generalize to non-trained WM activities, complex reasoning tasks, academic functioning, and behavioral symptoms of ADHD or working memory failure. Moreover, brain imaging studies have provided converging evidence of training-related improvements in working memory: specifically increased activation has been found in cortical regions implicated in working memory. However, no studies to date have investigated whether WM capacity can be improved in a population of young adults with ADHD/LD enrolled in post-secondary education programs. Nor have the results been replicated or elaborated upon using different imaging methodologies, like EEG (Electroencephalography), which is able to capture the millisecond time parameters of cognitive processing and so may provide new insights into the neural mechanism of WM and effects of WM training.
The overall objective of the current study is to determine the effectiveness of WM training, as administered by community-based psychologists licensed to provide this training, for college students with ADHD/LD. Specific objectives are to determine whether; i) standard-length computerized WM training enhances WM capacity in college students with ADHD/LD, using behavioral as well as neuro-imaging indices of change; ii) shortened-length WM training would also result in improvements in WM; iii) WM training normalizes WM performance, as compared to typically developing peers (i.e., a healthy comparison group of college students); iv) improvements in WM will generalize to secondary outcome tasks, such as inhibitory control and planning; v) WM training will also ameliorate ADHD symptoms of inattention and hyperactivity; and vi) improvements will be sustained for at least a few months after completing the training.
- Conditions
- Attention-Deficit Hyperactivity Disorder
- Being tested
- Cogmed Working Memory Training Program
- 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.
Cogmed Working Memory Training ProgramBehavioural
The Cogmed Working Memory Training Program will be used as the experimental program because of preliminary evidence indicating its effectiveness in enhancing WM and reducing behavioural symptoms of inattention/hyperactivity in children. This software-based training program was designed to improve WM abilities, particularly in children with ADHD or severe attention problems. It includes a set of auditory verbal and visual-spatial WM tasks presented via computer. All tasks involve: maintenance of simultaneous mental representations of multiple stimuli, unique sequencing of stimulus order in each trial and progressive adaptation of difficulty level as a function of individual performance.
| Study group | Role | What they receive |
|---|---|---|
| Wait-list Control | No intervention | Participants randomized to this group will not undergo The Cogmed Working Memory Training Program during the 5 week period, but will receive weekly phone calls from a member of the research team to review progress and advice on general time management, organization, and mnemonic strategies. After a 5-week period, participants in this arm will have access to the working memory training. |
| 15 Minute Training | Experimental | Participants will receive a low intensity version of The Cogmed Working Memory Training Program. This involves undergoing 25 training sessions for 15 minutes per day, 5 days a week for 5 weeks. Participants will also receive weekly phone calls from a CogMed Coach to review progress and adjust the training as needed. Receives: Behavioral: Cogmed Working Memory Training Program |
| 30 Minute Training | Experimental | Participants will receive the standard-length version of The Cogmed Working Memory Training Program. This involves undergoing 25 training sessions for 30 minutes per day, 5 days a week for 5 weeks. Participants will also receive weekly phone calls from a CogMed Coach to review progress and adjust the training as needed. Receives: Behavioral: Cogmed Working Memory Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wechsler Adult Intelligence Scale: Digit Span subtest
This task assesses auditory-verbal working memory. Participants are presented with a series of digits and must immediately repeat them back out loud. If they do this successfully, they are given a longer list.
Measured: within 120 days
Secondary outcomes (9)
Adult ADHD Self-Report Scale (ASRS v1.1)
This instrument consists of eighteen questions based on the criteria used for diagnosing ADHD in adults using DSM-IV-TR criteria.
Measured: within 120 days
'Add-3' working memory test
This task requires participants to add '3' to each digit in a set of 4 digits presented at a constant rate (e.g., the response to the set '3 1 5 4' should be '6 4 8 7')
Measured: within 120 days
Cambridge Neuropsychological Testing Automated Battery: Spatial Span Task
This task presents a set of white squares on a screen, which momentarily change colour in a variable sequence. The participant must then touch the boxes in the same order that they changed colour on the screen. Task demands intensify, as the number of boxes is increased from two to nine. However, if the participant makes an error, the next trial remains at the same difficulty level. Spatial span scores range from 0-9, with the score representing the highest level at which the participant reproduces at least one correct sequence.
Measured: within 120 days
Wide Range Assessment of Memory and Learning: Finger-Windows subtest
This task is a measure of nonverbal, rote sequential recall. The participant is asked to imitate gradually more difficult sequential patterns demonstrated by the examiner.
Measured: within 120 days
Barkley Deficits in Executive Functioning Scale (BDEFS)
This assessment tool evaluates dimensions of adult executive functioning in daily life.
Measured: within 120 days
Cognitive Failures Questionnaire
This self-report questionnaire measures perception, memory, and motor lapses in daily life.
Measured: within 120 days
Go-nogo task (N200, P300)
This task measures response inhibition. The subject is shown sequences of letters and instructed to press a button whenever a letter shows up on the screen, but to withhold a response whenever a letter occurs twice in a row.
Measured: within 120 days
Delayed Working Memory Task (P300)
The participant is shown sequences of either 2 (low load) or 4 (high load) shapes. After a delay period of two seconds, a probe appears and the participant needs to respond by pressing a button whether the probe stimulus was part of the sequence shown before or not.
Measured: within 120 days
Selective Working Memory Task (CDA)
The participant is shown an array of small colored squares to different parts of their visual field. This memory array will consist of either 2 (low load), 4 (high load), or 2 (low load + 2 'distractor' circle) items. After a delay, a test-array is shown and the participant is to respond whether the test-array matched the memory array.
Measured: within 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit Hyperactivity DisorderStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rosemary Tannock, University of Toronto
- Investigators
- Rosemary Tannock, Ph.D., Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657721
- Sponsor's protocol ID
- 245899
- Status last verified
- Aug 2012
- First submitted
- 27 Jul 2012
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu ZX, Glizer D, Tannock R, Woltering S. EEG alpha power during maintenance of information in working memory in adults with ADHD and its plasticity due to working memory training: A randomized controlled trial. Clin Neurophysiol. 2016 Feb;127(2):1307-1320. doi: 10.1016/j.clinph.2015.10.032. Epub 2015 Oct 20.
PubMed 26541307Mawjee K, Woltering S, Tannock R. Working Memory Training in Post-Secondary Students with ADHD: A Randomized Controlled Study. PLoS One. 2015 Sep 23;10(9):e0137173. doi: 10.1371/journal.pone.0137173. eCollection 2015.
PubMed 26397109
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Working Memory Training in Attention-Deficit/Hyperactivity Disorder: Neural Mechanisms of Change
- ClinicalTrials.gov ID
- NCT01657721
- Acronym / sponsor ID
- 245899
- Conditions
- Attention-Deficit Hyperactivity Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 6 Aug 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 overall objective of the current study is to determine whether computerized Working Memory (WM) training will enhance WM capacity in college students with Attention Deficit Hyperactivity Disorder (ADHD). There are also four additional objectives. The first is to investigate whether the program's efficacy is impacted by the duration of the daily training sessions. The second is to determine whether improvements in WM will generalize to secondary outcome tasks, such as inhibitory control and planning. The third objective is to examine whether WM training will also ameliorate ADHD symptoms of inattention and hyperactivity. The last objective is to investigate whether improvements will be maintained at a two month follow-up period. The investigators will also be assessing healthy control participants,who will not be receiving treatment, but will be used as a basis of comparison with the ADHD participants,
It is expected that the computerized WM training program will enhance WM capacity in college students with ADHD. In addition, it is believed that these increases in WM capacity will also lead to improvements in other executive functions. It is also hypothesized that WM training will lead to a reduction in ADHD symptomology. Lastly, these improvements should be maintained at three month follow-up.
Detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) and Learning Disability (LD) are among the most common neurobehavioural disorders, with prevalence rates estimated at about 5% to 9% . Approximately 4% of youth in the United States have a comorbid diagnosis of ADHD and a Learning Disability (ADHD/LD). Research has shown ADHD/LD symptoms persist into young adulthood, a time when many are enrolled in post-secondary education. Students with ADHD/LD at the post-secondary education level constitute an emergent subgroup of the ADHD and LD populations that have received far less attention in the literature compared to children, adolescents and employed adults. The actual percentage of college students with ADHD/LD is unknown; however, some estimates suggest that 2-8% of students attending post secondary education have ADHD, LD or both. Youth with the additive problems of both disorders are at high risk for academic failure, and poor psychosocial and occupational outcomes in adulthood. The "multiple deficit model" suggests that there is a common genetic and neuropsychological underpinning to these disorders. For example, ADHD and LD share similar features, such as core deficits in processing speed and working memory. ADHD and LD are each associated with several cognitive difficulties including poor working memory (WM) and processing speed. WM is a "mental workspace" that provides temporary storage and manipulation of information and is closely related to g, a proposed measure of general cognitive ability. In addition, WM has also been found to predict academic achievement. One major problem is that current intervention approaches for ADHD/LD do not target the underlying cognitive deficits fundamental to these diagnoses. Thus, interventions that address underlying cognitive difficulties, such as WM, are a promising avenue of additional treatment for youth with combined ADHD/LD.
WM capacity has generally been thought to be a fixed trait, but recent studies have suggested that it can be improved by intensive and adaptive computerized training. This intervention approach has been evaluated in children and adolescents with ADHD, older adults, and adult stroke patients and shown promising results. Subjects not only improved on the trained WM tasks, but some of the studies suggest that improvements may generalize to non-trained WM activities, complex reasoning tasks, academic functioning, and behavioral symptoms of ADHD or working memory failure. Moreover, brain imaging studies have provided converging evidence of training-related improvements in working memory: specifically increased activation has been found in cortical regions implicated in working memory. However, no studies to date have investigated whether WM capacity can be improved in a population of young adults with ADHD/LD enrolled in post-secondary education programs. Nor have the results been replicated or elaborated upon using different imaging methodologies, like EEG (Electroencephalography), which is able to capture the millisecond time parameters of cognitive processing and so may provide new insights into the neural mechanism of WM and effects of WM training.
The overall objective of the current study is to determine the effectiveness of WM training, as administered by community-based psychologists licensed to provide this training, for college students with ADHD/LD. Specific objectives are to determine whether; i) standard-length computerized WM training enhances WM capacity in college students with ADHD/LD, using behavioral as well as neuro-imaging indices of change; ii) shortened-length WM training would also result in improvements in WM; iii) WM training normalizes WM performance, as compared to typically developing peers (i.e., a healthy comparison group of college students); iv) improvements in WM will generalize to secondary outcome tasks, such as inhibitory control and planning; v) WM training will also ameliorate ADHD symptoms of inattention and hyperactivity; and vi) improvements will be sustained for at least a few months after completing the training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wait-list Control | No intervention | –Participants randomized to this group will not undergo The Cogmed Working Memory Training Program during the 5 week period, but will receive weekly phone calls from a member of the research team to review progress and advice on general time management, organization, and mnemonic strategies. After a 5-week period, participants in this arm will have access to the working memory training. |
| 15 Minute Training | Experimental | Behavioral: Cogmed Working Memory Training ProgramParticipants will receive a low intensity version of The Cogmed Working Memory Training Program. This involves undergoing 25 training sessions for 15 minutes per day, 5 days a week for 5 weeks. Participants will also receive weekly phone calls from a CogMed Coach to review progress and adjust the training as needed. |
| 30 Minute Training | Experimental | Behavioral: Cogmed Working Memory Training ProgramParticipants will receive the standard-length version of The Cogmed Working Memory Training Program. This involves undergoing 25 training sessions for 30 minutes per day, 5 days a week for 5 weeks. Participants will also receive weekly phone calls from a CogMed Coach to review progress and adjust the training as needed. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Formal diagnosis of ADHD by a doctor or psychologist
- Registered as a student at a post-secondary institution
- Registered with Student Disability/Accessibility Services at post-secondary institution
Key exclusion criteria (3 listed)
- Major neurological dysfunction and psychosis
- Current use of sedating or mood altering medication other than stimulants provided for ADHD
- Motor or perceptual handicap that would prevent using the computer program.
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 ProgramThe Cogmed Working Memory Training Program will be used as the experimental program because of preliminary evidence indicating its effectiveness in enhancing WM and reducing behavioural symptoms of inattention/hyperactivity in children. This software-based training program was designed to improve WM abilities, particularly in children with ADHD or severe attention problems. It includes a set of auditory verbal and visual-spatial WM tasks presented via computer. All tasks involve: maintenance of simultaneous mental representations of multiple stimuli, unique sequencing of stimulus order in each trial and progressive adaptation of difficulty level as a function of individual performance. | Behavioural | 15 Minute Training, 30 Minute Training |
Primary outcome
Wechsler Adult Intelligence Scale: Digit Span subtest
Time frame: within 120 days
This task assesses auditory-verbal working memory. Participants are presented with a series of digits and must immediately repeat them back out loud. If they do this successfully, they are given a longer list.
9 secondary outcomes
Adult ADHD Self-Report Scale (ASRS v1.1)
Time frame: within 120 days
'Add-3' working memory test
Time frame: within 120 days
Cambridge Neuropsychological Testing Automated Battery: Spatial Span Task
Time frame: within 120 days
Wide Range Assessment of Memory and Learning: Finger-Windows subtest
Time frame: within 120 days
Barkley Deficits in Executive Functioning Scale (BDEFS)
Time frame: within 120 days
Cognitive Failures Questionnaire
Time frame: within 120 days
Go-nogo task (N200, P300)
Time frame: within 120 days
Delayed Working Memory Task (P300)
Time frame: within 120 days
Selective Working Memory Task (CDA)
Time frame: within 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
- Derived from this study: PubMed 26541307Liu ZX, Glizer D, Tannock R, Woltering S. EEG alpha power during maintenance of information in working memory in adults with ADHD and its plasticity due to working memory training: A randomized controlled trial. Clin Neurophysiol. 2016 Feb;127(2):1307-1320. doi: 10.1016/j.clinph.2015.10.032. Epub 2015 Oct 20.
- Derived from this study: PubMed 26397109Mawjee K, Woltering S, Tannock R. Working Memory Training in Post-Secondary Students with ADHD: A Randomized Controlled Study. PLoS One. 2015 Sep 23;10(9):e0137173. doi: 10.1371/journal.pone.0137173. eCollection 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, Ph.D. principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cogmed Working Memory Training Program in people with Attention-Deficit Hyperactivity Disorder, run by University of Toronto 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: status not confirmed, as of the sponsor's last update on 6 Aug 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karizma Mawjee, M.A. (647-389-5103, karizma.mawjee@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wechsler Adult Intelligence Scale: Digit Span subtest (time frame: within 120 days). 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 NCT01657721, which also lists 2 linked publications.
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 6 Aug 2012.