Attention Deficit Hyperactivity DisorderCATSNCT00956605
A Trial of Computer-based Attention-training Systems in Children With Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Computer attention training systems for children with ADHD in people with Attention Deficit Hyperactivity Disorder, run by Tufts Medical Center at 1 site in United States.
Trial summary
This study examines the efficacy of two computer-based training systems to teach children with ADHD to attend more effectively. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Computer attention training systems for children with ADHD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jun 2007
- 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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- child in 6th, 7th or 8th grade
- a diagnosis of ADHD (any subtype) per report of the child's physician
- academic achievement at grade level
- ability to read in English sufficiently to complete assessments and intervention protocols
Who cannot join
- coexisting diagnosis of conduct disorder, pervasive developmental disorder, or other serious mental illness (e.g., bipolar disorder, psychosis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts Medical Center / Tufts University
Boston, Massachusetts, 02111
About this study
Official title: A Randomized Trial of Computer-based Attention-training Systems With and Without Neurofeedback in Children With ADHD
This study examines the efficacy of two computer-based training systems to teach children with ADHD to attend more effectively.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Computer attention training systems for children with ADHD
- Keywords
- EEG-biofeedback, neurofeedback, computer attention training systems, ADHD, ADD, child, children
- 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.
Computer attention training systems for children with ADHDBehavioural
Computer attention training systems for children with ADHD, one with and one without EEG-biofeedback, were delivered via approximately 20 sessions to the participants
| Study group | Role | What they receive |
|---|---|---|
| EEG biofeedback intervention | Experimental | Not described Receives: Behavioral: Computer attention training systems for children with ADHD |
| Non EEG biofeedback computerized attention training | Active comparator | Not described Receives: Behavioral: Computer attention training systems for children with ADHD |
| waitlist control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ADHD symptoms as reported by caregivers and teachers were measured at enrollment pre-intervention, and then again immediately post-intervention
Measured: Assessments were administered at enrollment in May-June 2006, and then immediately post-intervention after the 3 month intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startMay 2006
- Primary completionJun 2007
- Study completionJun 2007
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
- Crossover
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Naomi Steiner, MD, Principal investigator, Tufts Medical Center / Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956605
- Sponsor's protocol ID
- 7703
- Acronym
- CATS
- Status last verified
- Aug 2009
- First submitted
- 7 Aug 2009
- Last updated
- 11 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Computer-based Attention-training Systems With and Without Neurofeedback in Children With ADHD
- ClinicalTrials.gov ID
- NCT00956605
- Acronym / sponsor ID
- CATS / 7703
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- EEG-biofeedback, neurofeedback, computer attention training systems, ADHD, ADD, child, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 11 Aug 2009 (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.
This study examines the efficacy of two computer-based training systems to teach children with ADHD to attend more effectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EEG biofeedback intervention | Experimental | Behavioral: Computer attention training systems for children with ADHD |
| Non EEG biofeedback computerized attention training | Active comparator | Behavioral: Computer attention training systems for children with ADHD |
| waitlist control | No intervention | – |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- child in 6th, 7th or 8th grade
- a diagnosis of ADHD (any subtype) per report of the child's physician
- academic achievement at grade level
- ability to read in English sufficiently to complete assessments and intervention protocols
Key exclusion criteria (1 listed)
- coexisting diagnosis of conduct disorder, pervasive developmental disorder, or other serious mental illness (e.g., bipolar disorder, psychosis)
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 |
|---|---|---|
| Computer attention training systems for children with ADHDComputer attention training systems for children with ADHD, one with and one without EEG-biofeedback, were delivered via approximately 20 sessions to the participants | Behavioural | EEG biofeedback intervention, Non EEG biofeedback computerized attention training |
Primary outcome
Changes in ADHD symptoms as reported by caregivers and teachers were measured at enrollment pre-intervention, and then again immediately post-intervention
Time frame: Assessments were administered at enrollment in May-June 2006, and then immediately post-intervention after the 3 month intervention.
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 11 Aug 2009.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
Naomi Steiner, MD principal investigator
Tufts Medical Center / Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer attention training systems for children with ADHD in people with Attention Deficit Hyperactivity Disorder, run by Tufts Medical Center 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 1 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 11 Aug 2009. 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?
Changes in ADHD symptoms as reported by caregivers and teachers were measured at enrollment pre-intervention, and then again immediately post-intervention (time frame: Assessments were administered at enrollment in May-June 2006, and then immediately post-intervention after the 3 month intervention.). 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 11 Aug 2009.