Sponsor study identifier
interventional
208
1 country
1
Study Start
October 18, 2019
Actual (reported)Primary Completion
June 24, 2023
Actual (reported)Study Completion
June 24, 2023
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 24, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 18, 2019
Actual (reported)November 7, 2019
Actual (reported)December 26, 2019
Actual (reported)June 24, 2023
Actual (reported)June 24, 2023
Actual (reported)March 27, 2025
Actual (reported)Change in Cortisol AUCi
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.
2 hours, approx
Change Heart Rate Response
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.
2 hours
Dorsal Anterior Cingulate: Task-related Brain Activity (Judged Math vs. Math Alone)
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.
2 hours
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
Participants will be randomly assigned to one of 3 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Experimenter, No Social Partner.
Participants will be randomly assigned to one of 3 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Experimenter, No Social Partner.
The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.
Within 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Megan Gunnar, PhD
University of Minnesota
Kathleen Thomas, PhD
University of Minnesota
208 participants (actual enrollment reported by the registry).
First Submitted
November 7, 2019
First Posted
December 26, 2019
Study Start
October 18, 2019
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Using Shared Decision Making to Improve Family Media Use Planning
Left Anterior Insula: Task-related Brain Activity (Judged Math vs. Math Alone)
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.
2 hours
Right Anterior Insula: Task-related Brain Activity (Judged Math vs. Math Alone)
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.
2 hours
Ventromedial Prefrontal Cortex: Task-related Brain Activity (Judged Math vs. Math Alone)
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.
2 hours
Left Dorsolateral Prefrontal Cortex: Task-related Brain Activity (Judged Math vs. Math Alone)
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.
2 hours
Right Dorsolateral Prefrontal Cortex: Task-related Brain Activity (Judged Math vs. Math Alone)
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.
2 hours
Amygdala-vmPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)
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.
2 hours
Amygdala-left dlPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)
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.
2 hours
Amygdala-right dlPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)
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.
2 hours
Hypothalamus-vmPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)
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.
2 hours
Hypothalamus-left dlPFC Connectivity: fMRI Functional Connectivity (Speech vs. Rest)
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.
2 hours
Hypothalamus-right dlPFC Connectivity: fMRI Functional Connectivity (Speech vs. Rest)
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.
2 hours
Change in Salivary Alpha Amylase, AUCi
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.
2 hours
Participants will be randomly assigned to one of 3 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Experimenter, No Social Partner.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 24, 2023
Actual (reported)Study Completion
June 24, 2023
Actual (reported)Last Updated
March 30, 2026
Results First Posted
March 27, 2025
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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