Developmental Psychology Clinical Trial in Bethesda MD
NCT00060775
| Observational
This study is looking to recruit 1010 Participants
The purpose of this study is to use brain imaging technology to examine brain changes that
occur in children when they are exposed to various kinds of emotional tasks and to determine
if these changes are related to the child's temperament.
Studies suggest that the risk for developing mood and anxiety disorders in preschool children
may be linked to differences in temperament. The relationship between temperament and risk or
resilience may reflect the influences of brain activity on behavior at different stages of
childhood development. Behavioral inhibition and mood or anxiety disorders have been linked
to disturbances in the circuitry of several areas in the brain. However, the involvement of
this circuitry in temperament remains unclear. This study will use functional magnetic
resonance imaging (fMRI) to examine the function of different parts of the brain in children
who have previously undergone temperament studies and have had their temperaments classified.
Two sets of studies will be performed in the current protocol. A small set of pilot studies
will be performed in infants, by staff at the University of Maryland. In terms of the studies
among infants, these subjects will initially be contacted by staff at Maryland and then will
be seen at the NIH for up to three visits lasting between 4- to 5- hours during the first
year of life. These subjects also will undergo visits at the University of Maryland
throughout the first year of life.
This study will comprise up to four clinic visits. At Visit 1, children and their parents
will meet with study staff individually and together for psychiatric interviews. Children
will undergo a physical examination, medical history, a urine drug test, and practice in an
fMRI simulator. Saliva samples will be collected from the children and tests will be given to
assess stage of puberty, temperament, intelligence, feelings, experiences, and behavior.
Other visits include fMRI scans of the brain and other tasks.
Details for the study
Population
Community sample
Brief Title
The Psychobiology of Childhood Temperament
Official Title
The Psychobiology of Temperament: An fMRI Study
Brief Summary
The purpose of this study is to use brain imaging technology to examine brain changes that
<br /> occur in children when they are exposed to various kinds of emotional tasks and to determine
<br /> if these changes are related to the child's temperament.
<br />
<br /> Studies suggest that the risk for developing mood and anxiety disorders in preschool children
<br /> may be linked to differences in temperament. The relationship between temperament and risk or
<br /> resilience may reflect the influences of brain activity on behavior at different stages of
<br /> childhood development. Behavioral inhibition and mood or anxiety disorders have been linked
<br /> to disturbances in the circuitry of several areas in the brain. However, the involvement of
<br /> this circuitry in temperament remains unclear. This study will use functional magnetic
<br /> resonance imaging (fMRI) to examine the function of different parts of the brain in children
<br /> who have previously undergone temperament studies and have had their temperaments classified.
<br />
<br /> Two sets of studies will be performed in the current protocol. A small set of pilot studies
<br /> will be performed in infants, by staff at the University of Maryland. In terms of the studies
<br /> among infants, these subjects will initially be contacted by staff at Maryland and then will
<br /> be seen at the NIH for up to three visits lasting between 4- to 5- hours during the first
<br /> year of life. These subjects also will undergo visits at the University of Maryland
<br /> throughout the first year of life.
<br />
<br /> This study will comprise up to four clinic visits. At Visit 1, children and their parents
<br /> will meet with study staff individually and together for psychiatric interviews. Children
<br /> will undergo a physical examination, medical history, a urine drug test, and practice in an
<br /> fMRI simulator. Saliva samples will be collected from the children and tests will be given to
<br /> assess stage of puberty, temperament, intelligence, feelings, experiences, and behavior.
<br /> Other visits include fMRI scans of the brain and other tasks.
Detailed Description
Objectives: The goal of this proposal is to study temperament and risk-taking as
vulnerability factors for anxiety. Studies have documented that behaviorally inhibited (BI)
children are at risk for anxiety disorders. This vulnerability may be associated with neural
circuits underlying behavioral tendencies, such as components of the prefrontal cortex (PFC),
striatum, and amygdala. Regarding risk-taking behavior, certain high risk-taking adolescents
also carry enhanced vulnerability to anxiety. We use fMRI to examine local activity in PFC,
cingulate, amygdala, and striatum, and functional connectivity with resting state methodology
in two cohorts, one probing temperament and the other one risk-taking.
Study Population: A total of 1010 individuals/ infants (0-40 yo) will be studied. Subjects
must be between the ages of 2 months to 14 months, or between the ages of 7
years and 30 years old at the time of enrollment, as the measures we are utilizing are
designed for subjects who are in those age ranges. This sample comprises 2 sets of study
groups. First, the BI group includes individuals with (1) high motor arousal/high negative
affect in early infancy to novelty and sustained BI (BI), (2) high motor arousal/high
positive affect to novelty and sustained temperamental exuberance (exuberant), (3) average
levels of both reactivity/affect from infancy to childhood (controls). Second, the
risk-taking group includes 4 subgroups representing the interaction of two levels of anxiety
(low, high) and two levels of risk-taking (low, high). Finally, a group of healthy
individuals will be recruited as controls. Participants will be studied through the age of 40
because both the risk for and expressions of psychopathology continue to change throughout
early adulthood.
Design: Assessments will include psychiatric, behavioral, and neuropsychological batteries.
The protocol uses fMRI paradigms targeting different emotional, social, cognitive,
motivational, and learning processes during activation studies, as well as the intrinsic
function of the brain measured during a resting state.
Outcome Measures and Predictions: The main outcome measures are fMRI BOLD signal changes,
physiological, neuropsychological and behavioral variables. The proposed fMRI studies will
test 2 sets of hypotheses. The first refers to the BI cohort. BI subjects will exhibit (1)
enhanced amygdala activation to mild threats (e.g., angry facial), (2) PFC perturbations in
associative learning, (3) abnormal fronto-amygdala connectivity, (4) heightened striatal and
inferior PFC activation to reward stimuli, (5) unique neural patterns of attention bias and
social challenges, (6) differential changes with age as a function of BI status (7) infants
of differing temperaments will exhibit structural and functional differences in brain regions
associated with salience and ventral attention networks. The second set of hypotheses
pertains to the risk-taking cohort. (1) anxious adolescents will activate striatal regions in
response to reward more strongly than non-anxious adolescents; (2) risk-takers will also
activate striatal regions in response to reward more strongly than non-risk takers; (3) we
expect an interaction between risk-taking and anxiety-related factors, such as a potentiation
of striatal activation in anxious risk-takers, and a blunting of striatal activation in
non-anxious risk-takers. These effects will be uniquely altered by social stress. Finally,
repeat studies will be conducted with the BI cohort to examine stability/developmental
changes with time.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Task performance
Task performance on paradigms used in the scanner or in the clinic
Primary
fMRI BOLD signal
MRI BOLD signal changes in response to different paradigms testing different processes including threat, reward, social processes, conditioning, and attention
Study Criteria
INCLUSION CRITERIA:
- Consent: Can give consent/assent.
- Age: 2 months-14 months; 7-30 years
- IQ: All subjects will have IQ greater than 70. (exception: infants will not need to
meet this criteria)
- Psychopathology: all subjects will be free of lifetime history of psychosis and
pervasive developmental disorder
- Specific to infant cohort: between the ages of 4 and 14 months of age and is free of
any known developmental disability or medical condition
EXCLUSION CRITERIA:
- Any chronic or acute medical condition severe enough to interfere with task
performance or completion of questionnaires; Any medical condition that increases risk
for MRI (e.g. pacemaker, metallic foreign body in eye, dental braces)
- Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign
body in eye, dental braces).
- Any current axis I psychiatric disorder necessitating acute treatment.
- Claustrophobia
- Pregnancy
- Specific to infant cohort:
1. Was born prematurely, before 36 weeks gestation
2. Had a birth weight significantly below normal for gestational age
3. Has any known developmental disability or medical condition
4. Has any metallic objects in their body (e.g., Has implanted electrical devices,
brain stimulators, some types of dental implants, aneurysm clips (metal clips on
the wall of a large artery), metallic prostheses (including metal pins and rods,
heart valves, and cochlear implants), implanted delivery pump,
5. Comes from a home where the primary language spoken is not English
- NIMH employees and staff and their immediate family members will be excluded from the
study per NIMH policy.