- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01462032
Non-pharmacological Interventions for Preschoolers With Attention Deficit Hyperactivity Disorder (ADHD) (NIPA)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New York
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Flushing, New York, United States, 11367
- Queens College, City University of New York
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Child is hyperactive
- Child meets criteria for ADHD
- Child attends preschool or kindergarten
- Family speaks English at home
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive enhancing games
Children will be introduced to specific games believed to enhance cognitive functioning.
Parent will be encouraged to play these games with their children.
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Children will be taught games targeting these skills and parents will be encouraged to play these games with children at home
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Active Comparator: Parent support and education
Parents will participate in groups designed to provide information about ADHD and support for working with their child.
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Parents will participate in groups designed to provide information about ADHD and support for working with their child.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
These are parent and teacher ratings of ADHD symptoms
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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)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jeffrey M Halperin, Ph.D., Queens College, CUNY
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4R33MH085898-03 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Attention Deficit Hyperactivity Disorder
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Cingulate TherapeuticsRecruitingPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
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Ornit CohenUnknownAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersIsrael
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Cingulate TherapeuticsPremier Research Group plcActive, not recruitingADHD | Attention Deficit Hyperactivity Disorder | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
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Children's National Research InstituteRecruitingADHD | Attention Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder | Attention Deficit Disorder | ADD | ADHD Predominantly Inattentive Type | ADHD - Combined Type | ADHD, Predominantly Hyperactive - Impulsive | Attention-Deficit Disorder in Adolescence | Attention-Deficit Hyperactivity...United States
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Fondation LenvalCompletedAttention Deficit Disorder With Hyperactivity | Attention Deficit Disorder Without HyperactivityFrance
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University Hospital Bispebjerg and FrederiksbergMental Health Services in the Capital Region, DenmarkRecruitingSleep Disturbance | Neurodevelopmental Disorders | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder | Attention-Deficit Hyperactivity Disorder, Unspecified Type | Attention-deficit Hyperactivity | Hyperkinetic Conduct DisorderDenmark
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Corium, Inc.Worldwide Clinical Trials; Premier Research Group plc; Almac; Prometrika, LLCRecruitingAttention Deficit/Hyperactivity DisorderUnited States
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Corium, Inc.Premier Research Group plc; Almac; Prometrika, LLCRecruitingAttention Deficit/Hyperactivity DisorderUnited States
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Massachusetts General HospitalShire Human Genetic Therapies, Inc.Active, not recruitingAttention Deficit/Hyperactivity DisorderUnited States
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Ataturk UniversityCompletedAttention-deficit/Hyperactivity DisorderTurkey
Clinical Trials on Training Executive, Attention and Motor Skills (TEAMS)
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Queens College, The City University of New YorkCompletedAttention Deficit Hyperactivity DisorderUnited States
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Children's Hospital Medical Center, CincinnatiCompletedAttention Deficit Hyperactivity DisorderUnited States
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University of Medicine and Dentistry of New JerseyNational Institute of Mental Health (NIMH)CompletedSchizophreniaUnited States
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University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedExecutive Function | Language | Preschool Child
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Hacettepe UniversityCompletedHandwriting | Telerehabilitation | Fine Motor SkillsTurkey
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Massachusetts General HospitalNational Institute of Mental Health (NIMH)Completed
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Seoul National University HospitalCompletedAutism Spectrum Disorder | Autism | High-functioning AutismKorea, Republic of
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Memorial Sloan Kettering Cancer CenterRutgers UniversityCompletedCentral Nervous System LymphomaUnited States
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University of California, San FranciscoNational Institute of Mental Health (NIMH); University of California, BerkeleyCompletedAttention Deficit Disorder With HyperactivityUnited States
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Teachers College, Columbia UniversityRecruitingDepression | Anxiety | Distress, Emotional | Emotional DysfunctionUnited States