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临床试验/NCT04211155
NCT04211155已完成不适用

Neural Correlates of the Shift in Social Buffering of Social Evaluative Threat in 11-14 Year Olds

University of Minnesota1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2019年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
208
试验地点
1
主要终点
Amygdala-vmPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)

研究概览

简要总结

The purpose of this experiment is to determine the mechanisms through which parental buffering of stress physiology in response to social evaluative threat diminishes with pubertal development and whether this diminution of effectiveness extends to social buffering by peers (best friends) and/or other unfamiliar social partners (e.g., experimenters).

详细描述

On visit one, the participant will 1) be seen by a nurse who will complete a pubertal assessment exam, 2) complete questionnaires, including ones on pubertal development, screening for MRI safety, and quality of relations with parents and friends. The participant will also have a chance to experience a simulated MRI in order to determine whether they will be comfortable in an actual MRI.

Within 2 weeks the participant will return to the University where undergo the following protocol. Participants will be randomly assigned to one of 4 conditions that differ by who is with them in the scanner room: Primary Parent, Close Friend, Experimenter, No Social Partner. (N=50 per condition, 25 male, 25 female).

Once at the Center for Magnetic Resonance Research, participants and the individual who will be with the participant in the scanning room will undergo an MRI safety screening (the repeat of what the investigators completed over the phone). Girls will be shown to a changing room where the investigators will privately question them about any possibility of pregnancy. Participants will be shown into the scanning control room and one more safety check will be performed before they enter the scanner room and the scanner. If they are in one of the social buffering conditions, the social buffering partner will also enter the scanning room and will sit to the side of the scanner.

The scanning bed will then be moved into the barrel of the MRI machine. The participant will be wearing head phones to protect his/her hearing and to receive instructions from the control room. The participant will also be able to see two judges and hear the judges instructions when the participant is in the scanning control room. The participant will then complete a variant or the Trier Social Stress Test, a social evaluative stressor, which produces elevations in heart rate and cortisol.

When saliva is collected, the scanning bed is withdrawn from the barrel of the MRI machine and the participant will be able to see and briefly interact with the social partner while saliva is sampled for steroid collection. Once the scan is over the participant will return to a waiting area and complete additional questionnaires, provide additional saliva samples, and another urine sample.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
11 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • sufficient vision to complete assent and study procedures
  • sufficient hearing to complete assent and study procedures
  • sufficient language skills to provide verbal and written assent

排除标准

  • Premature birth (less than 37 weeks)
  • congenital and/or chromosomal disorders (e.g. cerebral palsy, FAS, mental retardation, Turner Syndrome, Down Syndrome, Fragile X)
  • Autism Spectrum Disorders
  • history of serious medical illness (e.g., cancer, organ transplant)
  • youth taking systemic glucocorticoids
  • youth taking beta-adrenergic medications
  • diagnoses of psychiatric illness, seizure disorder or other neurological disorders
  • contraindications for MRI (implanted medical device; presence of non-removal metal in or on the body, including piercings, orthodontic braces or certain permanent retainers)
  • known pregnancy
  • history of significant claustrophobia

结局指标

主要结局

Amygdala-vmPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)

时间窗: 2 hours

For each participant, signal intensity (unitless measure) will be measured using fMRI in the bilateral amygdala over a five-minute recording period. Signal intensity will also be measured using fMRI in the ventromedial prefrontal cortex (vmPFC) over the same period of time. A bivariate correlation will be conducted for these two data sets to determine functional connectivity, which will be reported as the r value of the correlation. This outcome measure will be reported as the mean difference in functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

Change in Cortisol AUCi

时间窗: 2 hours, approx

Area under the curve from initial (baseline) will be calculated and used in the analyses. Description = 9 saliva samples are collected during the course of the assessment. These samples are collected at (1) arrival for training purposes; T=0, (2) scan preparation; T=35 minutes, (3) entering scanner; T=55 minutes, (4) pre-TSST; T=75 minutes, (5) post-TSST; T=100 minutes, (6) pre-math alone; T=110 minutes, (7) post-math alone; T=120 minutes, (8) exiting scanner; T=130 minutes, (9) departure; T=140 minutes. Area under the curve at intercept (AUCi) is calculated using samples 2-7 with sample 2 as the intercept.

Change Heart Rate Response

时间窗: 2 hours

Heart rate will be derived from the EKG signal collected during periods of stress (social evaluation) and non-stress (no evaluation) during the course of the assessment. The variable, heart rate response, is a numeric output (reported in beats per minutes) from validated software (BIOPAC) which is calculated using a regression algorithm. The outcome measure will be reported as the difference between heart rate response during the period of stress and period of non-stress.

Dorsal Anterior Cingulate: Task-related Brain Activity (Judged Math vs. Math Alone)

时间窗: 2 hours

The difference in fMRI BOLD signal intensity in the bilateral dorsal anterior cingulate cortex (dACC) between the social evaluative stress condition (judged math) and non-stress condition (math without judges). Mean group differences in signal intensity between the two math tasks were extracted from a brain region defined by the Harvard-Oxford brain atlas anterior cingulate cortex thresholded at 50% confidence and dorsal to the genu of the corpus callosum.

Left Anterior Insula: Task-related Brain Activity (Judged Math vs. Math Alone)

时间窗: 2 hours

The difference in fMRI BOLD signal intensity in the left anterior insula between the social evaluative stress condition (judged math) and non-stress condition (math without judges). Mean group differences in signal intensity between the two math tasks were extracted from a brain region defined by the Harvard-Oxford brain atlas left insula thresholded at 50% confidence and anterior to the region's midpoint.

Right Anterior Insula: Task-related Brain Activity (Judged Math vs. Math Alone)

时间窗: 2 hours

The difference in fMRI BOLD signal intensity in the right anterior insula between the social evaluative stress condition (judged math) and non-stress condition (math without judges). Mean group differences in signal intensity between the two math tasks were extracted from a brain region defined by the Harvard-Oxford brain atlas right insula thresholded at 50% confidence and anterior to the region's midpoint.

Ventromedial Prefrontal Cortex: Task-related Brain Activity (Judged Math vs. Math Alone)

时间窗: 2 hours

The difference in fMRI BOLD signal intensity in the bilateral ventromedial prefrontal cortex (vmPFC) between the social evaluative stress condition (judged math) and non-stress condition (math without judges). Mean group differences in signal intensity between the two math tasks were extracted from a brain region defined by the combination of Harvard-Oxford brain atlas frontal pole, frontal medial cortex, and subcallosal cortex thresholded at 50% confidence and ventral to the genu of the corpus callosum and medial to the lateral edges of the Harvard-Oxford brain atlas frontal medial cortex.

Left Dorsolateral Prefrontal Cortex: Task-related Brain Activity (Judged Math vs. Math Alone)

时间窗: 2 hours

The difference in fMRI BOLD signal intensity in the left dorsolateral prefrontal cortex (left dlPFC) between the social evaluative stress condition (judged math) and non-stress condition (math without judges). Mean group differences in signal intensity between the two math tasks were extracted from a brain region defined by the Harvard-Oxford brain atlas left middle frontal gyrus thresholded at 50% confidence.

Right Dorsolateral Prefrontal Cortex: Task-related Brain Activity (Judged Math vs. Math Alone)

时间窗: 2 hours

The difference in fMRI BOLD signal intensity in the right dorsolateral prefrontal cortex (right dlPFC) between the social evaluative stress condition (judged math) and non-stress condition (math without judges). Mean group differences in signal intensity between the two math tasks were extracted from a brain region defined by the Harvard-Oxford brain atlas right middle frontal gyrus thresholded at 50% confidence.

Amygdala-left dlPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)

时间窗: 2 hours

For each participant, signal intensity (unitless measure) will be measured using fMRI in the amygdala over a five-minute recording period. Signal intensity will also be measured using fMRI in the left dorsolateral prefrontal cortex (dlPFC) over the same period of time. A bivariate correlation will be conducted for these two data sets to determine functional connectivity, which will be reported as the r value of the correlation. This outcome measure will be reported as the mean difference in functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

Amygdala-right dlPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)

时间窗: 2 hours

For each participant, signal intensity (unitless measure) will be measured using fMRI in the amygdala over a five-minute recording period. Signal intensity will also be measured using fMRI in the right dorsolateral prefrontal cortex (dlPFC) over the same period of time. A bivariate correlation will be conducted for these two data sets to determine functional connectivity, which will be reported as the r value of the correlation. This outcome measure will be reported as the mean difference in functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

Hypothalamus-vmPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)

时间窗: 2 hours

For each participant, signal intensity (unitless measure) will be measured using fMRI in the hypothalamus over a five-minute recording period. Signal intensity will also be measured using fMRI in the bilateral ventromedial prefrontal cortex (vmPFC) over the same period of time. A bivariate correlation will be conducted for these two data sets to determine functional connectivity, which will be reported as the r value of the correlation. This outcome measure will be reported as the mean difference in functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

Hypothalamus-left dlPFC Connectivity: fMRI Functional Connectivity (Speech vs. Rest)

时间窗: 2 hours

For each participant, signal intensity (unitless measure) will be measured using fMRI in the hypothalamus over a five-minute recording period. Signal intensity will also be measured using fMRI in the left dorsolateral prefrontal cortex (dlPFC) over the same period of time. A bivariate correlation will be conducted for these two data sets to determine functional connectivity, which will be reported as the r value of the correlation. This outcome measure will be reported as the mean difference in functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

Hypothalamus-right dlPFC Connectivity: fMRI Functional Connectivity (Speech vs. Rest)

时间窗: 2 hours

For each participant, signal intensity (unitless measure) will be measured using fMRI in the hypothalamus over a five-minute recording period. Signal intensity will also be measured using fMRI in the right dorsolateral prefrontal cortex (dlPFC) over the same period of time. A bivariate correlation will be conducted for these two data sets to determine functional connectivity, which will be reported as the r value of the correlation. This outcome measure will be reported as the mean difference in functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

Change in Salivary Alpha Amylase, AUCi

时间窗: 2 hours

salivary Alpha Amylase is used to index autonomic/sympathetic function. 9 saliva samples are collected during the course of the assessment. These samples are collected at (1) arrival; T=0, (2) scan preparation; T=35 minutes, (3) entering scanner; T=55 minutes, (4) pre-TSST; T=75 minutes, (5) post-TSST; T=100 minutes, (6) pre-math alone; T=110 minutes, (7) post-math alone; T=120 minutes, (8) exiting scanner; T=130 minutes, (9) departure; T=140 minutes. 4 samples (3-6) are assayed for salivary alpha amylase in micrograms per milliliter (sAA). Area under the curve at intercept (AUCi) is calculated using samples 3-6 with sample 3 as the intercept.

次要结局

  • Quality of Relationship With Primary Parent, BSV Positive Attachment Scale(Youth report, collected over course of 30 minutes)
  • Quality of Relationship With Close Friend, BSV Positive Attachment Scale(Youth reported, collected over course of 30 minutes)
  • Self Report of Stress(2 hours)
  • Peer Acceptance/Rejection(Parent report of child's general experience, collected over 30 minutes)
  • Behavioral Inhibition(Parent report of child's general experience, collected over 30 minutes)
  • Internalizing Symptoms(Parent report of child's general experience, collected over 30 minutes)
  • Externalizing Symptoms(Parent report of child's general experience, collected over 30 minutes)
  • Time Since Awakening(reported at the beginning of the 2 hour session)
  • Pretax Family Income. Potential Covariate(Parent report, collected over 30 minutes)
  • Parental Average Education Level. Potential Covariate(Parent report, collected over 30 minutes)
  • Caffeine or Nicotine Within 1 Hour of Testing. Potential Covariate(Youth report, at start of 2 hour session)
  • Granger Score(Youth report at the beginning of the 2 hour session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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