Developmental PsychologyNCT00060775
The Psychobiology of Childhood Temperament
An observational study of Developmental Psychology, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 60 years
- Conditions the study is for
- Developmental Psychology
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2003to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Community sample
Who may be able to join
- 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
Who cannot join
- 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:
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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 risktaking adolescents also carry enhanced vulnerability to anxiety. We use fMRI, EEG, and MEG to examine 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 1410 individuals/ infants (0-40 yo) will be studied. Subjects must be between the ages of 2 months to 14 months, or between the ages of 7 years and 60 years old at the time of enrollment, as the measures we are utilizing are designed for subjects who are in those age ranges. 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), or (4) high or low levels of parent-reported BI based on scores on the Behavioral Inhibition Questionnaire. 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. Participants will be studied through the age of 60 because both the risk for and expressions of psychopathology continue to change throughout early adulthood.
Design: Assessments will include psychiatric, behavioral, and neuropsychological batteries. The protocol uses fMRI and MEG/EEG 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
- Conditions
- Developmental Psychology
- Keywords
- Magnetic Resonance Imaging, Adolescence, Emotion, Behavioral Inhibition, Depression, Natural History
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-Targets | Characterized by temperament - no behavioral inhibition | |
| Parents | Parents of children enrolled in the study | |
| Targets | Characterized by temperament - high/low behavioral inhibition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task performance
Task performance on paradigms used in the scanner or in the clinic
Measured: 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
Measured: Up to 4 visits, though age 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2003 (estimated)
- Study start10 Nov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental PsychologyStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Maryland, College Park
- Responsible party
- Sponsor
- Investigators
- Daniel S Pine, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060775
- Sponsor's protocol ID
- 030186
- Other IDs
- 03-M-0186
- Status last verified
- 21 May 2026
- First submitted
- 12 May 2003
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stohr GM, Harrewijn A, Morales S, Zeytinoglu S, Laky ZE, Khosravi P, Cardinale EM, Lorenzo N, Stoddard J, Pine DS, Fox NA, Brotman MA, Haller SP. Adolescent cognitive control processing is associated with anxiety in young adulthood during the COVID-19 pandemic. Cogn Affect Behav Neurosci. 2025 Oct;25(5):1485-1495. doi: 10.3758/s13415-025-01293-1. Epub 2025 May 19.
PubMed 40389798
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psychobiology of Temperament: An fMRI Study
- ClinicalTrials.gov ID
- NCT00060775
- Acronym / sponsor ID
- 030186
- Conditions
- Developmental Psychology
- Keywords
- Magnetic Resonance Imaging, Adolescence, Emotion, Behavioral Inhibition, Depression, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Collaborators
- University of Maryland, College Park
- Study start
- 10 Nov 2003 (actual)
- First posted
- 13 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 risktaking adolescents also carry enhanced vulnerability to anxiety. We use fMRI, EEG, and MEG to examine 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 1410 individuals/ infants (0-40 yo) will be studied. Subjects must be between the ages of 2 months to 14 months, or between the ages of 7 years and 60 years old at the time of enrollment, as the measures we are utilizing are designed for subjects who are in those age ranges. 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), or (4) high or low levels of parent-reported BI based on scores on the Behavioral Inhibition Questionnaire. 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. Participants will be studied through the age of 60 because both the risk for and expressions of psychopathology continue to change throughout early adulthood.
Design: Assessments will include psychiatric, behavioral, and neuropsychological batteries. The protocol uses fMRI and MEG/EEG 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Targets | – | –Characterized by temperament - no behavioral inhibition |
| Parents | – | –Parents of children enrolled in the study |
| Targets | – | –Characterized by temperament - high/low behavioral inhibition |
Who may qualify
- Ages
- 2 months to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Community sample
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Task performance
Time frame: Up to 4 visits, though age 29
Task performance on paradigms used in the scanner or in the clinic
fMRI BOLD signal
Time frame: Up to 4 visits, though age 29
MRI BOLD signal changes in response to different paradigms testing different processes including threat, reward, social processes, conditioning, and attention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 40389798Stohr GM, Harrewijn A, Morales S, Zeytinoglu S, Laky ZE, Khosravi P, Cardinale EM, Lorenzo N, Stoddard J, Pine DS, Fox NA, Brotman MA, Haller SP. Adolescent cognitive control processing is associated with anxiety in young adulthood during the COVID-19 pandemic. Cogn Affect Behav Neurosci. 2025 Oct;25(5):1485-1495. doi: 10.3758/s13415-025-01293-1. Epub 2025 May 19.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Developmental Psychology
Not yet recruiting
Development, Implementation, and Evaluation of the HADAS Program for the Prevention of Eating Disorders in Adolescent Female Athletes, Coaches, and Families.
Eating Disorders, Body Image Dissatisfaction
Not yet recruiting
Implementing BEAM: A Scalable Digital Mental Health Program, for Families of Children Referred to Neurodevelopmental Services
Depression and Anxiety Symptom, Anger
Active, not recruitingObservational study
Development and Psychometric Validation of the Medical Dismissal Scale
Any Condition
Not yet recruiting
An Gratitude Programme Based on Islamic Teaching for the Well-Being of Emerging Adults
Psychological Well Being
Recruiting
Interventions in Mathematics and Cognitive Skills
Math Learning Disability, Child Development
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel S Pine, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Psychology, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Task performance (time frame: Up to 4 visits, though age 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00060775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.