ADHDCog-RASTNCT01124721
Effects of Cognitive Training on Academic Task Performance in Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Cognitive training in people with ADHD and Attention, run by University of California, Davis at 1 site in United States.
Trial summary
Impaired WM is a central deficit in ADHD. A computerized training program, Cogmed, has been shown to increase WM capacity in children with ADHD. It is not known whether the training improves behavior associated with classroom learning, such as remaining on-task and inhibiting off- task behavior. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- What is being tested?
- Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2013
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age range 7-14
- At least average academic and intellectual functioning via parent report.
- Must have ADHD (by parent report of previous diagnosis or per telephone screening checklist - to be confirmed via interview and ratings)
- Attentional, hyperactive or impulsive symptoms that interfere with functioning.
Who cannot join
- Diagnosis of severe mental illness for example, psychotic, bipolar or major depressive disorder, (by history)
- Mental retardation (by history)
- English is not the primary language
- Family does not have a computer
Trial locations and contacts
1 site in 1 country.
United States1 site
UCaliforniaDavis MIND Institute
Sacramento, California, 95825
About this study
Official title: Pilot Testing of Cognitive Training on Academic Task Performance in Children With Attention-deficit/Hyperactivity Disorder
Impaired WM is a central deficit in ADHD. A computerized training program, Cogmed, has been shown to increase WM capacity in children with ADHD. It is not known whether the training improves behavior associated with classroom learning, such as remaining on-task and inhibiting off- task behavior. The aim of this study is to utilize ecologically valid measures to investigate training's effect on observable ADHD behavior in conjunction with more standard measures. Subjects will be randomly assigned to a Cogmed versus an active "placebo" condition in which the tasks do not increase in difficulty level in a double-blinded fashion. The effects of the active Cogmed versus placebo computer training will be compared on measures in children with ADHD.
- Being tested
- Cognitive training, Cognitive training-placebo
- Keywords
- Cognitive 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.
Cognitive trainingBehavioural
Also called Cogmed
Cognitive computerized training for several days per week.
Cognitive training-placeboBehavioural
Also called Cogmed placebo
Cognitive training that only minimally increases in difficulty
| Study group | Role | What they receive |
|---|---|---|
| Cogmed cognitive training | Experimental | Computerized working memory, attention and cognitive tasks Receives: Behavioral: Cognitive training |
| Active placebo | Active comparator | Cognitive training, however the training does not increase in difficulty, or does so to a minimal degree. Receives: Behavioral: Cognitive training-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restricted Academic Situations Task
Assessment of on-task type behavior while doing a simulated academic task.
Measured: 6 weeks
Working memory measures
Assess memory and working memory functioning on computer and or RA administered tests.
Measured: 6 weeks
Rating scales
Parent and teacher ratings of behavior and attention
Measured: 6 weeks
Secondary outcomes (2)
Fluency and attention measures
Measures of fluency and attentional functioning.
Measured: 6 weeks
Self-control and executive functioning measures
Attention and working memory components can affect delay discounting and self-control measures. This measure will assess for change in behavior and ratings associated with executive functioning.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startJan 2008
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Schweitzer, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124721
- Sponsor's protocol ID
- 200816598
- Acronym
- Cog-RAST
- Status last verified
- May 2017
- First submitted
- 30 Apr 2010
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing of Cognitive Training on Academic Task Performance in Children With Attention-deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT01124721
- Acronym / sponsor ID
- Cog-RAST / 200816598
- Keywords
- Cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 May 2010 (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.
Impaired WM is a central deficit in ADHD. A computerized training program, Cogmed, has been shown to increase WM capacity in children with ADHD. It is not known whether the training improves behavior associated with classroom learning, such as remaining on-task and inhibiting off- task behavior. The aim of this study is to utilize ecologically valid measures to investigate training's effect on observable ADHD behavior in conjunction with more standard measures. Subjects will be randomly assigned to a Cogmed versus an active "placebo" condition in which the tasks do not increase in difficulty level in a double-blinded fashion. The effects of the active Cogmed versus placebo computer training will be compared on measures in children with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cogmed cognitive training | Experimental | Behavioral: Cognitive trainingComputerized working memory, attention and cognitive tasks |
| Active placebo | Active comparator | Behavioral: Cognitive training-placeboCognitive training, however the training does not increase in difficulty, or does so to a minimal degree. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age range 7-14
- At least average academic and intellectual functioning via parent report.
- Must have ADHD (by parent report of previous diagnosis or per telephone screening checklist - to be confirmed via interview and ratings)
- Attentional, hyperactive or impulsive symptoms that interfere with functioning.
Key exclusion criteria (4 listed)
- Diagnosis of severe mental illness for example, psychotic, bipolar or major depressive disorder, (by history)
- Mental retardation (by history)
- English is not the primary language
- Family does not have a computer
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 |
|---|---|---|
| Cognitive trainingAlso: CogmedCognitive computerized training for several days per week. | Behavioural | Cogmed cognitive training |
| Cognitive training-placeboAlso: Cogmed placeboCognitive training that only minimally increases in difficulty | Behavioural | Active placebo |
Primary outcome
Restricted Academic Situations Task
Time frame: 6 weeks
Assessment of on-task type behavior while doing a simulated academic task.
Working memory measures
Time frame: 6 weeks
Assess memory and working memory functioning on computer and or RA administered tests.
Rating scales
Time frame: 6 weeks
Parent and teacher ratings of behavior and attention
2 secondary outcomes
Fluency and attention measures
Time frame: 6 weeks
Self-control and executive functioning measures
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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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.
Julie Schweitzer, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training in people with ADHD and Attention, run by University of California, Davis at 1 site in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 31 May 2017. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Restricted Academic Situations Task (time frame: 6 weeks). The study lists 3 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 31 May 2017.