NCT01657721

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 6, 2012

Status Verified

August 1, 2012

Enrollment Period

2.3 years

First QC Date

July 27, 2012

Last Update Submit

August 3, 2012

Conditions

Attention-Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (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.

    within 120 days

Secondary Outcomes (9)

  • Adult ADHD Self-Report Scale (ASRS v1.1)

    within 120 days

  • 'Add-3' working memory test

    within 120 days

  • Cambridge Neuropsychological Testing Automated Battery: Spatial Span Task

    within 120 days

  • Wide Range Assessment of Memory and Learning: Finger-Windows subtest

    within 120 days

  • Barkley Deficits in Executive Functioning Scale (BDEFS)

    within 120 days

  • +4 more secondary outcomes

Study Arms (3)

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.

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.

Behavioral: Cogmed Working Memory Training Program

Interventions

Cogmed Working Memory Training ProgramBEHAVIORAL

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.

15 Minute Training30 Minute Training

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Toronto, Ontario, M5S1V6, Canada

RECRUITING

Related Publications (2)

  • 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.

    PMID: 26541307DERIVED

  • 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.

    PMID: 26397109DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Rosemary Tannock, Ph.D.

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karizma Mawjee, M.A.

CONTACT

647-389-5103karizma.mawjee@utoronto.ca

Steven Woltering, Ph.D.

CONTACT

416-668-0466steven.woltering@mail.utoronto.ca

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priniciple Investigator

Study Record Dates

First Submitted

July 27, 2012

First Posted

August 6, 2012

Study Start

May 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 6, 2012

Record last verified: 2012-08

Locations

CA(1)