Attention Deficit Hyperactivity DisorderPhase 1TEAMSNCT01073176
Training Executive, Attention and Motor Skills (TEAMS): Preliminary Studies
A Phase 1 study testing TEAMS (Training Attention Executive and Motor Skills) in people with Attention Deficit Hyperactivity Disorder, run by Queens College, The City University of New York at 1 site in United States.
Trial summary
Training Executive, Attention and Motor Skills (TEAMS) is a new research program for preschool children with Attention-Deficit/Hyperactivity Disorder (ADHD) that attempts to use game-like activities and physical exercise to promote the growth of neural processes that underlie the core features of the disorder (e.g.… Read more about this study
- Who is it for?
- Ages 4 to 5 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- TEAMS (Training Attention Executive and Motor Skills)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Mar 2011
- Phase
- Phase 1
- 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 4 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be at least 4.0 and less than 6.0 years of age;
- Receive a T-score on the Hyperactivity scale of the Behavior Assessment System for Children, Second Edition (BASC-2) of at least 65 (1.5 SD above the mean) by either teacher or parent rating, and a score of at least 60 (1 SD above the mean) by the other rater;
- Meet diagnostic criteria for ADHD-C or ADHD-HI as ascertained using the Kiddie-SADS, which will be administered to the parent.
Who cannot join
- Chronic medical illness or is taking systemic medication;
- Diagnosed neurological disorder;
- Full Scale IQ below 80 as measured by the Stanford-Binet - Fifth Edition Abbreviated Battery;
- Diagnosis of autism, pervasive developmental disorder or post-traumatic stress disorder;
- Determined to be physically aggressive with other children;
- Parent enrolled in a parent management training program;
- Not attending school or day
Trial locations and contacts
1 site in 1 country.
United States1 site
Queens College, City University of New York
Flushing, New York, 11367
About this study
Training Executive, Attention and Motor Skills (TEAMS) is a new research program for preschool children with Attention-Deficit/Hyperactivity Disorder (ADHD) that attempts to use game-like activities and physical exercise to promote the growth of neural processes that underlie the core features of the disorder (e.g., hyperactivity, impulsivity) as well as associated areas of difficulty (e.g., socialization, motor skills). These activities are implemented at home and in supervised playgroups at no cost to families and are coupled with extensive parental education about ADHD symptoms and associated impairments.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- TEAMS (Training Attention Executive and Motor Skills)
- Keywords
- ADHD, Executive function, Preschool children, Treatment, Memory, Attention, Training, Cognitive enhancement
- 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.
TEAMS (Training Attention Executive and Motor Skills)Other
Also called Cognitive enhancement
Training Executive, Attention and Motor Skills (TEAMS) is a new research program for preschool children with Attention-Deficit/Hyperactivity Disorder (ADHD) that attempts to use game-like activities and physical exercise to promote the growth of neural processes that underlie the core features of the disorder (e.g., hyperactivity, impulsivity) as well as associated areas of difficulty (e.g., socialization, motor skills). These activities are implemented at home and in supervised playgroups at no cost to families and are coupled with extensive parental education about ADHD symptoms and associated impairments.
| Study group | Role | What they receive |
|---|---|---|
| TEAMS | Experimental | TEAMS has been designed to promote executive skills, memory and fine motor control, and includes game-like activities that allow for increases in task complexity. Receives: Other: TEAMS (Training Attention Executive and Motor Skills) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Diary of Engagement in Games at Home
Parents complete diaries indicating the games/exercises that they engaged in with their children, as well as the amount of time per day and the degree to which the activities were enjoyable.
Measured: Weekly during intervention, 1 month follow-up, 3 month follow-up
Secondary outcomes (2)
Attention Deficit Hyperactivity Disorder Rating Scale IV(ADHD-RS-IV)
Parent and teacher ratings of ADHD symptom severity
Measured: Pre intervention, post intervention, 1 month follow-up, 3 month follow-up
Parent Satisfaction Questionnaire
Parents rate the palatability of the intervention across a number of dimensions.
Measured: Post intervention, 1 month follow-up, 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startApr 2009
- Primary completionMar 2011
- Study completionMar 2011
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queens College, The City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Halperin, Queens College, The City University of New York
- Investigators
- Jeffrey M Halperin, PhD, Principal investigator, Queens College, City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073176
- Sponsor's protocol ID
- R21MH085898
- Acronym
- TEAMS
- Status last verified
- Sep 2011
- First submitted
- 22 Feb 2010
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Executive, Attention and Motor Skills (TEAMS): Preliminary Studies
- ClinicalTrials.gov ID
- NCT01073176
- Acronym / sponsor ID
- TEAMS / R21MH085898
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Executive function, Preschool children, Treatment, Memory, Attention, Training, Cognitive enhancement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Queens College, The City University of New YorkUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 23 Feb 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.
Training Executive, Attention and Motor Skills (TEAMS) is a new research program for preschool children with Attention-Deficit/Hyperactivity Disorder (ADHD) that attempts to use game-like activities and physical exercise to promote the growth of neural processes that underlie the core features of the disorder (e.g., hyperactivity, impulsivity) as well as associated areas of difficulty (e.g., socialization, motor skills). These activities are implemented at home and in supervised playgroups at no cost to families and are coupled with extensive parental education about ADHD symptoms and associated impairments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEAMS | Experimental | Other: TEAMS (Training Attention Executive and Motor Skills)TEAMS has been designed to promote executive skills, memory and fine motor control, and includes game-like activities that allow for increases in task complexity. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Be at least 4.0 and less than 6.0 years of age;
- Receive a T-score on the Hyperactivity scale of the Behavior Assessment System for Children, Second Edition (BASC-2) of at least 65 (1.5 SD above the mean) by either teacher or parent rating, and a score of at least 60 (1 SD above the mean) by the other rater;
- Meet diagnostic criteria for ADHD-C or ADHD-HI as ascertained using the Kiddie-SADS, which will be administered to the parent.
Key exclusion criteria (7 listed)
- Chronic medical illness or is taking systemic medication;
- Diagnosed neurological disorder;
- Full Scale IQ below 80 as measured by the Stanford-Binet - Fifth Edition Abbreviated Battery;
- Diagnosis of autism, pervasive developmental disorder or post-traumatic stress disorder;
- Determined to be physically aggressive with other children;
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 |
|---|---|---|
| TEAMS (Training Attention Executive and Motor Skills)Also: Cognitive enhancementTraining Executive, Attention and Motor Skills (TEAMS) is a new research program for preschool children with Attention-Deficit/Hyperactivity Disorder (ADHD) that attempts to use game-like activities and physical exercise to promote the growth of neural processes that underlie the core features of the disorder (e.g., hyperactivity, impulsivity) as well as associated areas of difficulty (e.g., socialization, motor skills). These activities are implemented at home and in supervised playgroups at no cost to families and are coupled with extensive parental education about ADHD symptoms and associated impairments. | Other | TEAMS |
Primary outcome
Daily Diary of Engagement in Games at Home
Time frame: Weekly during intervention, 1 month follow-up, 3 month follow-up
Parents complete diaries indicating the games/exercises that they engaged in with their children, as well as the amount of time per day and the degree to which the activities were enjoyable.
2 secondary outcomes
Attention Deficit Hyperactivity Disorder Rating Scale IV(ADHD-RS-IV)
Time frame: Pre intervention, post intervention, 1 month follow-up, 3 month follow-up
Parent Satisfaction Questionnaire
Time frame: Post intervention, 1 month follow-up, 3 month follow-up
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 14 Sep 2011.
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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.
Jeffrey M Halperin, PhD principal investigator
Queens College, City University of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TEAMS (Training Attention Executive and Motor Skills) in people with Attention Deficit Hyperactivity Disorder, run by Queens College, The City University of New York 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 3 inclusion and 7 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 14 Sep 2011. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Daily Diary of Engagement in Games at Home (time frame: Weekly during intervention, 1 month follow-up, 3 month follow-up). 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 14 Sep 2011.