NCT00060775

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2003

Completed
6 months until next milestone

Study Start

First participant enrolled

November 10, 2003

Completed
Last Updated

March 31, 2026

Status Verified

December 23, 2025

First QC Date

May 12, 2003

Last Update Submit

March 28, 2026

Conditions

Keywords

Magnetic Resonance ImagingAdolescenceEmotionBehavioral InhibitionDepressionNatural History

Outcome Measures

Primary Outcomes (2)

  • Task performance

    Task performance on paradigms used in the scanner or in the clinic

    Up to 4 visits, though age 29

  • fMRI BOLD signal

    MRI BOLD signal changes in response to different paradigms testing different processes including threat, reward, social processes, conditioning, and attention

    Up to 4 visits, though age 29

Study Arms (3)

Non-Targets

Characterized by temperament - no behavioral inhibition

Parents

Parents of children enrolled in the study

Targets

Characterized by temperament - high/low behavioral inhibition

Eligibility Criteria

Age2 Months - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Community sample

You may qualify if:

  • Consent: Can give consent/assent.
  • Age: 2 months-14 months; 7-60 years
  • Children in Cohort 4: Age: 9-11 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

You may not qualify if:

  • 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:
  • Was born prematurely, before 36 weeks gestation
  • Had a birth weight significantly below normal for gestational age
  • Has any known developmental disability or medical condition
  • 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,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Daniel S Pine, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2003

First Posted

May 13, 2003

Study Start

November 10, 2003

Last Updated

March 31, 2026

Record last verified: 2025-12-23

Data Sharing

IPD Sharing
Will not share

Locations