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Working Memory Training in ADHD (The Engage Study)

Primary Purpose

Attention-Deficit Hyperactivity Disorder

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Cogmed Working Memory Training Program
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention-Deficit Hyperactivity Disorder

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Ontario Institute of Studies in Education (OISE) at The University of TorontoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Wait-list Control

15 Minute Training

30 Minute Training

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
'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')
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.
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.
Barkley Deficits in Executive Functioning Scale (BDEFS)
This assessment tool evaluates dimensions of adult executive functioning in daily life.
Cognitive Failures Questionnaire
This self-report questionnaire measures perception, memory, and motor lapses in daily life.
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.
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.
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.

Full Information

First Posted
July 27, 2012
Last Updated
August 3, 2012
Sponsor
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01657721
Brief Title
Working Memory Training in ADHD (The Engage Study)
Official Title
Working Memory Training in Attention-Deficit/Hyperactivity Disorder: Neural Mechanisms of Change
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wait-list Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
15 Minute Training
Arm Type
Experimental
Arm Description
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.
Arm Title
30 Minute Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cogmed Working Memory Training Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wechsler Adult Intelligence Scale: Digit Span subtest
Description
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.
Time Frame
within 120 days
Secondary Outcome Measure Information:
Title
Adult ADHD Self-Report Scale (ASRS v1.1)
Description
This instrument consists of eighteen questions based on the criteria used for diagnosing ADHD in adults using DSM-IV-TR criteria.
Time Frame
within 120 days
Title
'Add-3' working memory test
Description
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')
Time Frame
within 120 days
Title
Cambridge Neuropsychological Testing Automated Battery: Spatial Span Task
Description
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.
Time Frame
within 120 days
Title
Wide Range Assessment of Memory and Learning: Finger-Windows subtest
Description
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.
Time Frame
within 120 days
Title
Barkley Deficits in Executive Functioning Scale (BDEFS)
Description
This assessment tool evaluates dimensions of adult executive functioning in daily life.
Time Frame
within 120 days
Title
Cognitive Failures Questionnaire
Description
This self-report questionnaire measures perception, memory, and motor lapses in daily life.
Time Frame
within 120 days
Title
Go-nogo task (N200, P300)
Description
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.
Time Frame
within 120 days
Title
Delayed Working Memory Task (P300)
Description
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.
Time Frame
within 120 days
Title
Selective Working Memory Task (CDA)
Description
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.
Time Frame
within 120 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karizma Mawjee, M.A.
Phone
647-389-5103
Email
karizma.mawjee@utoronto.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Woltering, Ph.D.
Phone
416-668-0466
Email
steven.woltering@mail.utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosemary Tannock, Ph.D.
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ontario Institute of Studies in Education (OISE) at The University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S1V6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosemary Tannock, Ph.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
26541307
Citation
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.
Results Reference
derived
PubMed Identifier
26397109
Citation
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.
Results Reference
derived

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Working Memory Training in ADHD (The Engage Study)

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