Brain Imaging and Computer Games in Children With Either Bipolar Disorder, ADHD, Anxiety or Healthy Controls (BBPP)
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Purpose
The purpose of this research is to learn more about how children with mental health problems, including bipolar disorder (BD), attention deficit hyperactivity disorder (ADHD), and generalized anxiety disorder (GAD), differ from children without these problems. The investigators want to understand how these 4 groups of children differ in brain activity, function, and structure.
| Condition |
|---|
|
Bipolar Disorder Attention Deficit Disorder With Hyperactivity Attention Deficit Disorder Without Hyperactivity Generalized Anxiety Disorder Healthy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Brain/Behavior Alterations in Pediatric Psychopathology |
- Behavioral performance on computerized tasks [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
- MRI data (neural activation) during behavioral task [ Time Frame: Day 2 ] [ Designated as safety issue: No ]structural, functional and diffusion tensor imaging data will be collected during the second day of the study.
- Genetic material [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Genetic samples (spit sample) will be examined in relation to neural activation, function, and structure as well as behavioral performance on computerized tasks.
Biospecimen Retention: Samples With DNA
Spit samples are collected for DNA/RNA extraction.Genetic tests will be performed at the Brown University affiliated Molecular Genetics Laboratory located at the Providence VA Medical Center. For privacy purposes, all genetic samples will be assigned a study code number to ensure that there is no identifiable information with them. After this study is over, genetic samples will be disposed.
| Estimated Enrollment: | 240 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Bipolar Disorder
Children, 7- 17 years-old, who meet diagnostic criteria for bipolar disorder, Type 1
|
|
ADHD/ADD
Children, 7-17 years-old, who meet diagnostic criteria for attention deficit/hyperactivity disorder (ADHD) OR attention deficit disorder (without hyperactivity)
|
|
Generalized Anxiety Disorder (GAD)
Children, 7-17 years-old, who meet diagnostic criteria for Generalized Anxiety Disorder (GAD)
|
|
Health Controls
Children, ages 7-17 years-old, without a history of psychiatric diagnosis
|
Detailed Description:
This study has 2 visits (total time ~6 hours):
Visit #1 (2-3 hours), includes: (a) detailed description of study and study consent, (b) interviews about the child's mental health, mood, and behavior, and (c) a screening IQ test (word games, playing with blocks).
If a child fits our study criteria, they will play some special computer games, provide a spit sample for DNA, and parents/children will complete questionnaires.
All children fitting our study criteria, will also be invited to complete visit #2 (2 hours) consisting of a special MRI brain scan at Brown University (Providence, RI). To make sure all children feel comfortable in the MRI, they will spend time in our practice MRI (i.e., "MRI simulator") that looks and sounds just like the real MRI. During the actual MRI, children will play a computerized game in which they can win and lose points. The MRI lasts one and a half hours (at most).
Participants are compensated for their time.
Eligibility| Ages Eligible for Study: | 7 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Participants will be recruited from in and around the Providence. Rhode Island area
General Inclusion Criteria:
- English- speaking,children & adolescents between the ages of 7- 17
- consenting parent/guardian
General Exclusion Criteria:
- estimated IQ less than 70
- substance/alcohol use or dependence within the last 2 months
- Autism Spectrum Disorders or primary psychosis
- medical/neurological conditions that mimic the psychiatric disorders of interest
- implanted metal (NO BRACES or COCHLEAR IMPLANT)
For inclusion in the Bipolar group, participants:
- have to meet Diagnostic and Statistical Manual, 4th Edition Text Revision (DSM-IV-TR) criteria for BD Type I, including at least one lifetime episode of mania
For inclusion in the ADHD/ADD group, participants:
- meet DSM-IV-TR criteria for any subtype of ADHD or ADD
- can not currently meet diagnostic criteria for bipolar, depressive or anxiety disorders
For inclusion in the Generalized Anxiety Group (GAD), participants:
- have to meet DSM-IV-TR criteria for GAD
- can not currently meet diagnostic criteria for Obsessive Compulsive Disorder (OCD) or Post-Traumatic Stress Disorder (PTSD)
For inclusion in the Healthy Control group, participants:
- can not have a past/current history of psychiatric or substance use disorders
- can not have a first-degree relative (parents, brothers/sisters) with a history of psychiatric illness
Contacts and Locations| Contact: PediMIND Program | 401-432-1600 | pedimind@gmail.com |
| Contact: PediMIND Program | 401-432-1600 |
| United States, Rhode Island | |
| Bradley Hospital | Recruiting |
| East Providence, Rhode Island, United States, 02915 | |
| Principal Investigator: Daniel P Dickstein, MD | |
More Information
Additional Information:
Publications:
| Responsible Party: | Bradley Hospital |
| ClinicalTrials.gov Identifier: | NCT01570426 History of Changes |
| Other Study ID Numbers: | 0195-07, K22MH074945 |
| Study First Received: | March 27, 2012 |
| Last Updated: | April 2, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Bradley Hospital:
|
Attention Deficit Disorder with Hyperactivity Attention Deficit Disorder without Hyperactivity Bipolar disorder Mood disorders ADHD Anxiety disorders Generalized anxiety disorder Magnetic resonance imaging Mental disorders |
Mental disorders diagnosed in childhood affective neuroscience emotion MRI fMRI neurocognitive tasks imaging Healthy controls typical development |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Anxiety Disorders Bipolar Disorder Hyperkinesis Mental Disorders Affective Disorders, Psychotic Mood Disorders |
Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013