The Psychobiology of Childhood Temperament
|First Received Date ICMJE||May 12, 2003|
|Last Updated Date||April 11, 2014|
|Start Date ICMJE||May 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00060775 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Psychobiology of Childhood Temperament|
|Official Title ICMJE||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.
This study will comprise three 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.
Recent research delineates developmental pathways to mood and anxiety disorders. Among preschool children, prospective and family-based studies suggest that early risk and resilience may be linked to individual differences in temperament or other behavioral characteristics such as risk-intolerance/risk-seeking. The proposal uses fMRI to examine PFC, cingulate cortex, amygdala, and striatal function as well as resting state, in two groups of individuals, (1) temperamentally classified, i.e., individuals previously classified with a state-of-the-art temperament battery and followed prospectively into early adulthood, and (2) classified by patterns of risk behavior and anxiety trait, i.e., individuals classified by level of trait anxiety and propensity for risk-taking behavior.
A total of 980 children will be studied as adolescents and young adults (7-25 years old). The selection of participants for this study will be based on features that were identified during assessments at UMD in the distant past, when the participants were infants and toddlers. There are four sub-groups that will be invited to participate: (1) those who exhibit high motor arousal/high negative affect in early infancy in response to novel stimuli and who display behavioral inhibition from infancy to childhood (behaviorally inhibited), (2) those who exhibit high motor arousal/high positive affect in response to novel stimuli and who display temperamental exuberance from infancy to childhood (exuberant), 3) those who exhibit approximate average levels of both reactivity/affect in infancy and inhibition/exuberance from infancy to childhood (controls), and 4) those who will be selected based on their level of anxiety and risk taking behavior. Minors can continue to participate after they become adults, and will be re-consented at their first visit after reaching age 18 with the adult volunteer consent form. Another pool of participants for this protocol are children and adolescents recruited from the community in order to help validate new paradigms and as healthy controls. Assessments will include psychiatric, behavioral, and neuropsychological batteries. The protocol uses fMRI paradigms previously developed for studies of adolescents or targeting specific processes: face processing parametric task, monetary incentive delay task, reward card task, saccade eye movement task, social-evaluation rating tasks, attention bias task, fear conditioning task, signal detection task, loss aversion task, risk-taking task, Wheel of Fortune (WOF) task, conflict detection, and attentional disengagement task. The processes probed by these tasks are studied in different contexts that manipulate arousal and emotion (e.g., social, threat dimensions).
The proposed fMRI studies are designed to test three hypotheses related to inhibited temperament. First, behaviorally inhibited adolescents are hypothesized to exhibit enhanced amygdala activation when exposed to mild threats in the form of facial emotion displays. Second, behaviorally inhibited adolescents are hypothesized to exhibit reduced activation of the PFC and cingulate while attending to emotion vs. physical features present in facial threats. Third, exuberant adolescents are hypothesized to exhibit enhanced activation of striatum and inferior PFC during the presentation of reward stimuli.
An additional set of hypotheses related to anxiety trait and risk-taking will also be tested. First, anxious adolescents/young adults will activate striatal regions in response to reward more strongly than non-anxious adolescents/young adults. Second, risk-takers will also activate striatal regions in response to reward more strongly than non-risk taking adolescents. Third, we expect an interaction between risk-taking and anxious factors. Some of these adolescents may be asked to join a smoking cessation treatment study. FMRI data may be shared with Dr. Carl Lejuez and Dr. Laura MacPherson for the additional purpose of examining whether reward-related pattern of activation can predict treatment outcome.
Finally, participants will be asked to come back and repeat scanning studies to evaluate the stability of the findings. We will conduct two types of reliability studies: (1) In a long-term reliability study, we will first focus on adolescents, and ask them to come back to repeat the study 3.5 years later on average. (2) In a short-term reliability study, we will focus on children 9 years of age. Because studies need to be short in young children based on their difficulty of staying still for relatively long periods of time, we will complete the fMRI studies in two visits instead of one. During the second fMRI visit, we will have time to repeat the task already done on the first fMRI visit since we will not have to run clinical scans. The second fMRI visit will occur within two weeks on average of the first fMRI visit.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||980|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Consent: Can give consent/assent.
IQ: All subjects will have IQ greater than 70.
Psychopathology: All subjects will be free of lifetime history of psychosis and pervasive developmental disorder.
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 current axis I psychiatric disorder necessitating acute treatment.
|Ages||7 Years to 25 Years|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00060775|
|Other Study ID Numbers ICMJE||030186, 03-M-0186|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 2014|
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