Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060775
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2003-05-12
Brief Title:
The Psychobiology of Childhood Temperament
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Psychobiology of Temperament An fMRI Study
Status:
RECRUITING
Status Verified Date:
2024-08-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs 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
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 arousalhigh negative affect in early infancy to novelty and sustained BI BI 2 high motor arousalhigh positive affect to novelty and sustained temperamental exuberance exuberant 3 average levels of both reactivityaffect 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 MEGEEG 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 eg 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 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 arousalhigh negative affect in early infancy to novelty and sustained BI BI 2 high motor arousalhigh positive affect to novelty and sustained temperamental exuberance exuberant 3 average levels of both reactivityaffect 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 MEGEEG 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-M-0186 | None | None | None |