Brain Imaging and Computer Games in Children With Either Bipolar Disorder, ADHD, Anxiety or Healthy Controls (BBPP)
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.
Attention Deficit Disorder With Hyperactivity
Attention Deficit Disorder Without Hyperactivity
Generalized Anxiety Disorder
|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.
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Children, 7- 17 years-old, who meet diagnostic criteria for bipolar disorder, Type 1
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)
Children, ages 7-17 years-old, without a history of psychiatric diagnosis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570426
|Contact: PediMIND Programemail@example.com|
|Contact: PediMIND Program||401-432-1600|
|United States, Rhode Island|
|East Providence, Rhode Island, United States, 02915|
|Principal Investigator: Daniel P Dickstein, MD|