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The Psychobiology of Childhood Temperament

This study is currently recruiting participants.
Verified September 25, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT00060775
First Posted: May 13, 2003
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
  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.

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.


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) ( National Institute of Mental Health (NIMH) ):

Estimated Enrollment: 1010
Study Start Date: May 9, 2003
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 (0-25 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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Consent: Can give consent/assent.
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 12, 2003
First Posted: May 13, 2003
Last Update Posted: October 6, 2017
Last Verified: September 25, 2017

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

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