The Psychobiology of Childhood Temperament
|First Received Date ICMJE||May 12, 2003|
|Last Updated Date||June 11, 2016|
|Start Date ICMJE||May 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00060775 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Psychobiology of Childhood Temperament|
|Official Title ICMJE||The Psychobiology of Temperament: An fMRI Study|
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.
This study will comprise three 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.
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 risk8
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
Study Population: A total of 980 individuals (7-25 yo) will be studied. 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.
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
adolescents 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, (4)
unique neural patterns of attention bias and social challenges, (5) differential changes
with age as a function of BI status. The second set of hypotheses pertains to the risk32
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 non37
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||980|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Consent: Can give consent/assent.
IQ: All subjects will have IQ greater than 70.
Psychopathology: All subjects will be free of lifetime history of psychosis and pervasive developmental disorder.
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 current axis I psychiatric disorder necessitating acute treatment.
|Ages||7 Years to 25 Years (Child, Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00060775|
|Other Study ID Numbers ICMJE||030186, 03-M-0186|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute of Mental Health (NIMH)|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP