COMPLETED

The Psychobiology of Childhood Temperament

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Psychobiology of Temperament: An fMRI Study

Quick Facts

Study Start:2003-11-10
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT00060775

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Months to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Consent: Can give consent/assent.
  2. * Age: 2 months-14 months; 7-60 years
  3. * Children in Cohort 4: Age: 9-11 years
  4. * IQ: All subjects will have IQ greater than 70. (exception: infants will not need to meet this criteria)
  5. * Psychopathology: all subjects will be free of lifetime history of psychosis and pervasive developmental disorder
  6. * 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
  1. * 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)
  2. * Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign body in eye, dental braces).
  3. * Any current axis I psychiatric disorder necessitating acute treatment.
  4. * Claustrophobia
  5. * Pregnancy
  6. * Specific to infant cohort:
  7. 1. Was born prematurely, before 36 weeks gestation
  8. 2. Had a birth weight significantly below normal for gestational age
  9. 3. Has any known developmental disability or medical condition
  10. 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,
  11. 5. Comes from a home where the primary language spoken is not English
  12. * NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.

Contacts and Locations

Principal Investigator

Daniel S Pine, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Mental Health (NIMH)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Mental Health (NIMH)

  • Daniel S Pine, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Mental Health (NIMH)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2003-11-10
Study Completion DateN/A

Study Record Updates

Study Start Date2003-11-10
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • Magnetic Resonance Imaging
  • Adolescence
  • Emotion
  • Behavioral Inhibition
  • Depression
  • Natural History

Additional Relevant MeSH Terms

  • Developmental Psychology