The Psychobiology of Childhood Temperament

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT00060775
First received: May 12, 2003
Last updated: August 25, 2016
Last verified: August 2016
  Purpose

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.


Condition
Mood Disorders
Anxiety Disorders
Adolescents

Study Type: Observational
Official Title: The Psychobiology of Temperament: An fMRI Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 980
Study Start Date: May 2003
  Hide Detailed Description

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 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

risk-taking.

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.

  Eligibility

Ages Eligible for Study:   7 Years to 25 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

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.

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 current axis I psychiatric disorder necessitating acute treatment.

Claustrophobia

Pregnancy

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060775

Contacts
Contact: Adina Heckelman (240) 723-0925 adina.heckelman@nih.gov
Contact: Daniel S Pine, M.D. (301) 594-1318 pined@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
University of Maryland, College Park Recruiting
College Park, Maryland, United States
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Daniel S Pine, M.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00060775     History of Changes
Other Study ID Numbers: 030186  03-M-0186 
Study First Received: May 12, 2003
Last Updated: August 25, 2016
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Magnetic Resonance Imaging
fMRI
Emotion
Children
Adolescence
Affective Neuroscience
Neuroimaging
Behavioral Inhibition
Depression
Anxiety
Normal Volunteers
Healthy Volunteer
HV

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Mood Disorders
Pathologic Processes
Mental Disorders

ClinicalTrials.gov processed this record on August 25, 2016