Attention Deficit Hyperactivity DisorderCMHNCT02610244
Examining Benefits of Modified Cogmed Training With ADHD at Cambridge Memorial Hospital(CMH)
A study testing Modified Cogmed Training in people with Attention Deficit Hyperactivity Disorder, run by Cambridge Memorial Hospital at 1 site in Canada.
Trial summary
ADHD youth (8-16 years) will be randomized to either treatment-as-usual group or a modified version of the Cogmed program (MCT) that is suitable for use in a hospital setting (duration = 3 daily 35-min sessions for 10 weeks). Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Modified Cogmed Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Dec 2019
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth who are between 8-16 years age.
- Youth with a primary diagnosis of ADHD per psychiatric and psychological assessment.
- Youth with an estimated Intelligence Quotient (IQ) equal or greater than 80 on an intelligence measure (Wechsler Abbreviated Scale of Intelligence; WASI), where the average IQ varies from 90-110.
- Youth with reading comprehension at or above a grade 2 level on a standardized reading test (Wechsler Individual Achievement Test - 3rd Edition; WIAT-III).
- Youth who are receiving medication will have made an adequate adjustment to their medication as shown by stable blood levels, psychiatric consultation, and self and parent report at least 2 weeks prior to the start of their acceptance into this study.
Who cannot join
- Youth who are younger than 8 or older than 16 at the time of enrollment.
- Youth who do not have a primary diagnosis of ADHD.
- Youth with an estimated Intelligence Quotient (IQ) below 80 on an intelligence measure (Wechsler Abbreviated Scale of Intelligence; WASI), where the average IQ varies from 90-110. Children with intellectual functioning below this level have been found to have trouble following instructions that are necessary for the training program.
- Youth with reading comprehension below a grade 2 level on a standardized reading test (Wechsler Individual Achievement Test - 3rd Edition; WIAT-III). Children with reading skills below this level have been found to have trouble following instructions that are necessary for the training program.
- Youth do not intend to begin new medication, discontinue existing medication, or change dose in medication - unless indicated per their doctor's instructions - for the duration of their involvement in the study.
- Youth cannot be accepted into the study if they have a significant medical impairment that would preclude their participation, a significant uncorrected visual/hearing deficit that would make it difficult for them to see a computer screen and follow verbal instructions, and/or a significant problem with their fine motor control that would make it difficult for them to use a keyboard.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining Benefits of Modified Cogmed Training With ADHD Youth at Cambridge Memorial Hospital (CMH)
ADHD youth (8-16 years) will be randomized to either treatment-as-usual group or a modified version of the Cogmed program (MCT) that is suitable for use in a hospital setting (duration = 3 daily 35-min sessions for 10 weeks). The main objectives are to determine whether there is improvement in working memory and attention, a reduction in concerns related to ADHD and social emotional behaviour,and transfer effects for reading and math following participation in our MCT.
Read the detailed description
The Cogmed working memory training program consists of 5 daily 50-min sessions for 5 weeks. This program has been identified as a promising intervention for youth with Attention Deficit Hyperactivity Disorder (ADHD) who have deficits in aspects of executive functioning (EF), such as working memory (WM) and attention (ATT), as well as social-emotional behavior (SEB). Findings regarding the efficacy and generalization of transfer effects associated with Cogmed have been mixed, possibly due to methodological limitations of the standard program. In our study, these limitations will be addressed with ADHD youth (8-16 years) in a randomized controlled trial using a modified version of the Cogmed program (MCT) that is suitable for use in a hospital setting (duration = 3 daily 35-min sessions for 10 weeks). The main objective is to determine whether there is improvement in WM and ATT, a reduction in concerns related to ADHD and SEB, and transfer effects for reading and math following participation in our MCT.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Modified Cogmed Training
- 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.
Modified Cogmed TrainingOther
Comparison of outcome measures between treatment-as-usual group and Modified Cogmed Training group after 10 weeks and 3 months follow up.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual | No intervention | Standard treatment as usual as directed by the physician. |
| Modified Cogmed Training | Experimental | 10 weeks of computerized training (3x weekly for 35-minutes each session) that targets thinking skills that are often impaired in individuals diagnosed with ADHD. Receives: Other: Modified Cogmed Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes assessed for Working Memory Index (BRIEF measure) and working memory (verbal and Visual-spatial) as measured on Alloway Working Memory Test
The BRIEF Parent/Teacher ratings of youth's working memory index and Youth 's scores on Alloway Working Memory test at baseline will be compared with scores after 10 weeks modified cogmed training or treament-as-usual, and after 3 months
Measured: Baseline,10 weeks, 3 months
Changes assessed on Beck Self-Concept
Self-concept measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
Measured: Baseline,10 weeks, 3 months
Change assessed on Tova Attention Performance Index
Attention Performance Index measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
Measured: Baseline,10 weeks, 3 months
Change assessed on Wiat-111 Reading comprehension and math problem-solving
Reading Comprehension and Math problem-solving measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
Measured: Baseline,10 weeks, 3 months
Change assessed on Achenbach Reduction in Total Problems Scale
Total Problem scale measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
Measured: Baseline,10 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2019
- Study completionDec 2019
Why it stopped: Original sponsor withdrew funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Waterloo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610244
- Sponsor's protocol ID
- ADHD-MCT-09092015
- Other IDs
- 2015-0563, 20679
- Acronym
- CMH
- Status last verified
- Jan 2020
- First submitted
- 12 Nov 2015
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Benefits of Modified Cogmed Training With ADHD Youth at Cambridge Memorial Hospital (CMH)
- ClinicalTrials.gov ID
- NCT02610244
- Acronym / sponsor ID
- CMH / ADHD-MCT-09092015
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Original sponsor withdrew funding.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cambridge Memorial HospitalUniversity, hospital or other
- Collaborators
- University of Waterloo
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 20 Nov 2015 (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.
ADHD youth (8-16 years) will be randomized to either treatment-as-usual group or a modified version of the Cogmed program (MCT) that is suitable for use in a hospital setting (duration = 3 daily 35-min sessions for 10 weeks). The main objectives are to determine whether there is improvement in working memory and attention, a reduction in concerns related to ADHD and social emotional behaviour,and transfer effects for reading and math following participation in our MCT.
Detailed description
The Cogmed working memory training program consists of 5 daily 50-min sessions for 5 weeks. This program has been identified as a promising intervention for youth with Attention Deficit Hyperactivity Disorder (ADHD) who have deficits in aspects of executive functioning (EF), such as working memory (WM) and attention (ATT), as well as social-emotional behavior (SEB). Findings regarding the efficacy and generalization of transfer effects associated with Cogmed have been mixed, possibly due to methodological limitations of the standard program. In our study, these limitations will be addressed with ADHD youth (8-16 years) in a randomized controlled trial using a modified version of the Cogmed program (MCT) that is suitable for use in a hospital setting (duration = 3 daily 35-min sessions for 10 weeks). The main objective is to determine whether there is improvement in WM and ATT, a reduction in concerns related to ADHD and SEB, and transfer effects for reading and math following participation in our MCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual | No intervention | –Standard treatment as usual as directed by the physician. |
| Modified Cogmed Training | Experimental | Other: Modified Cogmed Training10 weeks of computerized training (3x weekly for 35-minutes each session) that targets thinking skills that are often impaired in individuals diagnosed with ADHD. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Youth who are between 8-16 years age.
- Youth with a primary diagnosis of ADHD per psychiatric and psychological assessment.
- Youth with an estimated Intelligence Quotient (IQ) equal or greater than 80 on an intelligence measure (Wechsler Abbreviated Scale of Intelligence; WASI), where the average IQ varies from 90-110.
- Youth with reading comprehension at or above a grade 2 level on a standardized reading test (Wechsler Individual Achievement Test - 3rd Edition; WIAT-III).
- Youth who are receiving medication will have made an adequate adjustment to their medication as shown by stable blood levels, psychiatric consultation, and self and parent report at least 2 weeks prior to the start of their acceptance into this study.
Key exclusion criteria (6 listed)
- Youth who are younger than 8 or older than 16 at the time of enrollment.
- Youth who do not have a primary diagnosis of ADHD.
- Youth with an estimated Intelligence Quotient (IQ) below 80 on an intelligence measure (Wechsler Abbreviated Scale of Intelligence; WASI), where the average IQ varies from 90-110. Children with intellectual functioning below this level have been found to have trouble following instructions that are necessary for the training program.
- Youth with reading comprehension below a grade 2 level on a standardized reading test (Wechsler Individual Achievement Test - 3rd Edition; WIAT-III). Children with reading skills below this level have been found to have trouble following instructions that are necessary for the training program.
- Youth do not intend to begin new medication, discontinue existing medication, or change dose in medication - unless indicated per their doctor's instructions - for the duration of their involvement in the study.
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 |
|---|---|---|
| Modified Cogmed TrainingComparison of outcome measures between treatment-as-usual group and Modified Cogmed Training group after 10 weeks and 3 months follow up. | Other | Modified Cogmed Training |
Primary outcome
Changes assessed for Working Memory Index (BRIEF measure) and working memory (verbal and Visual-spatial) as measured on Alloway Working Memory Test
Time frame: Baseline,10 weeks, 3 months
The BRIEF Parent/Teacher ratings of youth's working memory index and Youth 's scores on Alloway Working Memory test at baseline will be compared with scores after 10 weeks modified cogmed training or treament-as-usual, and after 3 months
Changes assessed on Beck Self-Concept
Time frame: Baseline,10 weeks, 3 months
Self-concept measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
Change assessed on Tova Attention Performance Index
Time frame: Baseline,10 weeks, 3 months
Attention Performance Index measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
Change assessed on Wiat-111 Reading comprehension and math problem-solving
Time frame: Baseline,10 weeks, 3 months
Reading Comprehension and Math problem-solving measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
Change assessed on Achenbach Reduction in Total Problems Scale
Time frame: Baseline,10 weeks, 3 months
Total Problem scale measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.
Results and safety
The study was stopped early (reason given: Original sponsor withdrew funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Cogmed Training in people with Attention Deficit Hyperactivity Disorder, run by Cambridge Memorial Hospital 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 23 Jan 2020. 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.
Are results available for this study?
The study was stopped early (reason given: Original sponsor withdrew funding.). Results are not available in the source record.
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?
Changes assessed for Working Memory Index (BRIEF measure) and working memory (verbal and Visual-spatial) as measured on Alloway Working Memory Test (time frame: Baseline,10 weeks, 3 months). The study lists 5 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 23 Jan 2020.