Attention Deficit Hyperactivity DisorderPhase 2NIPANCT01462032
Non-pharmacological Interventions for Preschoolers With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 2 study testing Training Executive, Attention and Motor Skills (TEAMS) and Parent support and education 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
This study is designed to evaluate two potential treatments for children with Attention-deficit/Hyperactivity Disorder (ADHD) that do not involve the use of medication. Our goal is to develop new interventions for preschoolers with ADHD that will result in enduring reductions of ADHD symptoms and associated… Read more about this study
- Who is it for?
- Ages 48 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Training Executive, Attention and Motor Skills (TEAMS) and Parent support and education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Mar 2014
- Phase
- Phase 2
- 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 48 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child is hyperactive
- Child meets criteria for ADHD
- Child attends preschool or kindergarten
- Family speaks English at home
Who cannot join
- Family does not speak English at home
- Child does not attend preschool/kindergarten
- Child is diagnosed with or suspected of having PDD
- Child has IQ of less than 80
- Child is being treated with psychotropic medication
- Child has a diagnosed neurological disorder
Show all 10Show fewer
- Child is aggressive
- Child is only inattentive and does not exhibit signs of hyperactivity
- Parent has attended parent management classes
- Child is not physically able to participate in group play sessions
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
Official title: Training Executive, Attention, and Motor Skills (TEAMS): Preliminary Studies
This study is designed to evaluate two potential treatments for children with Attention-deficit/Hyperactivity Disorder (ADHD) that do not involve the use of medication. Our goal is to develop new interventions for preschoolers with ADHD that will result in enduring reductions of ADHD symptoms and associated impairments in children, and thus prevent long-term difficulties characteristic of many children with ADHD.
Both interventions involve weekly playgroups (of roughly five children) in which children engage in designated activities while parents engage in groups focusing on parent education, support, and their children's activities. It is hypothesized that both interventions will be helpful, but that only one will have lasting effects well beyond the end of active treatment.
Read the detailed description
Children eligible for this study are:
- 4 and 5 years-old (between the ages of 48 - 72 months)
- shows signs and symptoms of hyperactivity, impulsiveness and/or inattention. To enter the study, following our evaluation, they will need to meet diagnostic criteria for ADHD
- enrolled in a preschool or daycare setting
Children are ineligible to participate in this study if they:
- are currently being treated with psychotropic medication
- have a diagnosed neurological disorder
- have an autism spectrum pr pervasive developmental disorder
- are intellectually impaired
- are highly physically aggressive
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Training Executive, Attention and Motor Skills (TEAMS), Parent support and education
- Keywords
- Preschool Children, ADHD, Treatment, Non-pharmacological
- 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.
Training Executive, Attention and Motor Skills (TEAMS)Behavioural
Children will be taught games targeting these skills and parents will be encouraged to play these games with children at home
Parent support and educationBehavioural
Parents will participate in groups designed to provide information about ADHD and support for working with their child.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive enhancing games | Experimental | Children will be introduced to specific games believed to enhance cognitive functioning. Parent will be encouraged to play these games with their children. Receives: Behavioral: Training Executive, Attention and Motor Skills (TEAMS) |
| Parent support and education | Active comparator | Parents will participate in groups designed to provide information about ADHD and support for working with their child. Receives: Behavioral: Parent support and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Clinical Global Improvement Scale Rating at Post-Treatment, 1 Month, and 3 Months after Treatment
This is a clinical rating based on data derived from parent and teacher ratings as well as a semi-structured clinical interview with the child's caretaker.
Measured: Assessed pre-treatment (@ 0 weeks), post-treatment (@ 5 weeks after treatment onset), 1-month follow-up (@ 9 weeks after treatment onset) and 3 months follow-up (@ 21 weeks after treatment onset)
Secondary outcomes (1)
Change from Baseline Parent and Teacher Ratings on the ADHD-RS at Post-Treatment, 1 month, and 3 months after Treatment
These are parent and teacher ratings of ADHD symptoms
Measured: Assessed pre-treatment (@ 0 weeks), post-treatment (@ 5 weeks after treatment onset), 1-month follow-up (@ 9 weeks after treatment onset) and 3 months follow-up (@ 21 weeks after treatment onset)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
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, Ph.D., Principal investigator, Queens College, CUNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462032
- Sponsor's protocol ID
- 4R33MH085898-03
- Acronym
- NIPA
- Status last verified
- Jun 2014
- First submitted
- 13 Sep 2011
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Halperin JM, Marks DJ, Chacko A, Bedard AC, O'Neill S, Curchack-Lichtin J, Bourchtein E, Berwid OG. Training Executive, Attention, and Motor Skills (TEAMS): a Preliminary Randomized Clinical Trial of Preschool Youth with ADHD. J Abnorm Child Psychol. 2020 Mar;48(3):375-389. doi: 10.1007/s10802-019-00610-w.
PubMed 31834588
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. 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
- NCT01462032
- Acronym / sponsor ID
- NIPA / 4R33MH085898-03
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Preschool Children, ADHD, Treatment, Non-pharmacological
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Queens College, The City University of New YorkUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Oct 2011 (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 is designed to evaluate two potential treatments for children with Attention-deficit/Hyperactivity Disorder (ADHD) that do not involve the use of medication. Our goal is to develop new interventions for preschoolers with ADHD that will result in enduring reductions of ADHD symptoms and associated impairments in children, and thus prevent long-term difficulties characteristic of many children with ADHD.
Both interventions involve weekly playgroups (of roughly five children) in which children engage in designated activities while parents engage in groups focusing on parent education, support, and their children's activities. It is hypothesized that both interventions will be helpful, but that only one will have lasting effects well beyond the end of active treatment.
Detailed description
Children eligible for this study are:
- 4 and 5 years-old (between the ages of 48 - 72 months)
- shows signs and symptoms of hyperactivity, impulsiveness and/or inattention. To enter the study, following our evaluation, they will need to meet diagnostic criteria for ADHD
- enrolled in a preschool or daycare setting
Children are ineligible to participate in this study if they:
- are currently being treated with psychotropic medication
- have a diagnosed neurological disorder
- have an autism spectrum pr pervasive developmental disorder
- are intellectually impaired
- are highly physically aggressive
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive enhancing games | Experimental | Behavioral: Training Executive, Attention and Motor Skills (TEAMS)Children will be introduced to specific games believed to enhance cognitive functioning. Parent will be encouraged to play these games with their children. |
| Parent support and education | Active comparator | Behavioral: Parent support and educationParents will participate in groups designed to provide information about ADHD and support for working with their child. |
Who may qualify
- Ages
- 48 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child is hyperactive
- Child meets criteria for ADHD
- Child attends preschool or kindergarten
- Family speaks English at home
Key exclusion criteria (10 listed)
- Family does not speak English at home
- Child does not attend preschool/kindergarten
- Child is diagnosed with or suspected of having PDD
- Child has IQ of less than 80
- Child is being treated with psychotropic medication
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 |
|---|---|---|
| Training Executive, Attention and Motor Skills (TEAMS)Children will be taught games targeting these skills and parents will be encouraged to play these games with children at home | Behavioural | Cognitive enhancing games |
| Parent support and educationParents will participate in groups designed to provide information about ADHD and support for working with their child. | Behavioural | Parent support and education |
Primary outcome
Change from Baseline Clinical Global Improvement Scale Rating at Post-Treatment, 1 Month, and 3 Months after Treatment
Time frame: Assessed pre-treatment (@ 0 weeks), post-treatment (@ 5 weeks after treatment onset), 1-month follow-up (@ 9 weeks after treatment onset) and 3 months follow-up (@ 21 weeks after treatment onset)
This is a clinical rating based on data derived from parent and teacher ratings as well as a semi-structured clinical interview with the child's caretaker.
1 secondary outcome
Change from Baseline Parent and Teacher Ratings on the ADHD-RS at Post-Treatment, 1 month, and 3 months after Treatment
Time frame: Assessed pre-treatment (@ 0 weeks), post-treatment (@ 5 weeks after treatment onset), 1-month follow-up (@ 9 weeks after treatment onset) and 3 months follow-up (@ 21 weeks after treatment onset)
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 4 Jun 2014.
- Derived from this study: PubMed 31834588Halperin JM, Marks DJ, Chacko A, Bedard AC, O'Neill S, Curchack-Lichtin J, Bourchtein E, Berwid OG. Training Executive, Attention, and Motor Skills (TEAMS): a Preliminary Randomized Clinical Trial of Preschool Youth with ADHD. J Abnorm Child Psychol. 2020 Mar;48(3):375-389. doi: 10.1007/s10802-019-00610-w.
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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, Ph.D. principal investigator
Queens College, CUNY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Training Executive, Attention and Motor Skills (TEAMS) and Parent support and education 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 4 inclusion and 10 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 4 Jun 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from Baseline Clinical Global Improvement Scale Rating at Post-Treatment, 1 Month, and 3 Months after Treatment (time frame: Assessed pre-treatment (@ 0 weeks), post-treatment (@ 5 weeks after treatment onset), 1-month follow-up (@ 9 weeks after treatment onset) and 3 months follow-up (@ 21 weeks after treatment onset)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01462032, which also lists 1 linked publication.
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 4 Jun 2014.