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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Karizma Mawjee, M.A. contact

647-389-5103

karizma.mawjee@utoronto.ca

Steven Woltering, Ph.D. contact

416-668-0466

steven.woltering@mail.utoronto.ca

Canada1 site, 1 recruiting
  • Ontario Institute of Studies in Education (OISE) at The University of Toronto

    Toronto, Ontario, M5S1V6

    Rosemary Tannock, Ph.D.

    Recruiting

Other trials in Canada

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.

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 groups in NCT01657721
Study groupRoleWhat they receive
Wait-list ControlNo interventionParticipants 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 TrainingExperimentalParticipants 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 TrainingExperimentalParticipants 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.

  1. 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)
  1. 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

  2. '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

  3. 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

  4. 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

  5. Barkley Deficits in Executive Functioning Scale (BDEFS)

    This assessment tool evaluates dimensions of adult executive functioning in daily life.

    Measured: within 120 days

  6. Cognitive Failures Questionnaire

    This self-report questionnaire measures perception, memory, and motor lapses in daily life.

    Measured: within 120 days

  7. 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

  8. 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

  9. 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.

  1. First posted6 Aug 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionSep 2014 (estimated)
  4. Study completionSep 2014 (estimated)

Resources

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)
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 26541307
  • Mawjee 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

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.

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