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Social StressNCT04211155

Neural Correlates of the Shift in Social Buffering of Social Evaluative Threat

A study testing Questionnaires and MRI in people with Social Stress and Adolescent Behavior, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 11 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Social Stress, Adolescent Behavior
What is being tested?
Questionnaires and MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
1 siteUnited States
Study dates
18 Oct 2019to 24 Jun 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 11 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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
  • tattoos
  • history of significant claustrophobia

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

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

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).

Read the detailed description

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.

Being tested
Questionnaires, MRI
Medical subject headings
Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnairesOther

    The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.

  • MRIOther

    Within 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.

Study groups in NCT04211155
Study groupRoleWhat they receive
Primary ParentExperimentalParticipants 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.
Receives: Other: Questionnaires; Other: MRI
ExperimenterExperimentalParticipants 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.
Receives: Other: Questionnaires; Other: MRI
No Social PartnerExperimentalParticipants 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.
Receives: Other: Questionnaires; Other: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 hours, approx

  2. 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.

    Measured: 2 hours

  3. 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.

    Measured: 2 hours

  4. 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.

    Measured: 2 hours

  5. 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.

    Measured: 2 hours

  6. 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.

    Measured: 2 hours

  7. 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.

    Measured: 2 hours

  8. 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.

    Measured: 2 hours

  9. 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.

    Measured: 2 hours

  10. 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.

    Measured: 2 hours

  11. 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.

    Measured: 2 hours

  12. 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.

    Measured: 2 hours

  13. 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.

    Measured: 2 hours

  14. 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.

    Measured: 2 hours

  15. 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.

    Measured: 2 hours

Secondary outcomes (12)
  1. Self Report of Stress

    Self-report of stress using a Likert-type scale with 5 levels of stress felt: (1) Not At All, (2) A Little, (3) Some, (4) A Lot, (5) A Whole Lot. Level of stress was reported for 4 points during the assessment: (1) How stressed did you feel when you first arrived at the University and we were walking into the building, (2) How stressful was the period of time when you were preparing your speech and thinking about what to say?, (3) How stressful was giving the speech?, (4) How stressful was the math with judges?. Mean Stress reactivity was calculated as the mean of (2, 3, 4) minus the value at arrival (1).

    Measured: 2 hours

  2. Peer Acceptance/Rejection

    Scale on the MacArthur Health and Behavior Questionnaire, Potential Covariate, 5pt Scale (1-5), High Scores Indicate Peer Acceptance

    Measured: Parent report of child's general experience, collected over 30 minutes

  3. Behavioral Inhibition

    Scale on the MacArthur Health and Behavior Questionnaire. Potential Covariate, 3pt scale (0,1,2), high scores indicate inhibition

    Measured: Parent report of child's general experience, collected over 30 minutes

  4. Internalizing Symptoms

    Higher Order Measure From the MacArthur Health and Behavior Questionnaire. Potential Covariate 3pt scale (0,1,2), high scores indicate Internalizing

    Measured: Parent report of child's general experience, collected over 30 minutes

  5. Externalizing Symptoms

    Higher Order Measure From the MacArthur Health and Behavior Questionnaire. Potential Covariate 3pt scale (0,1,2), high scores indicate externalizing

    Measured: Parent report of child's general experience, collected over 30 minutes

  6. Time Since Awakening

    Participants self-report the clock time that they woke up on the day of the assessment, and the clock time when the imaging test was done. The difference between these times was calculated and reported in hours. This is only a potential covariate for cortisol, which follows a circadian rhythm.

    Measured: reported at the beginning of the 2 hour session

  7. Pretax Family Income. Potential Covariate

    Parents report on gross family income on an 11-point ordinal scale: (1) Less than $15,000, (2) $15,001 to $25,000, (3) $25,001 to $35,000, (4) $35,001 to $50,000, (5) $50,001 to $75,000, (6) $75,001 to $100,000, (7) $100,001 to $125,000, (8) $125,001 to $150,000, (9) $150,001 to $175,000, (10) $175,001 to 200,000, (11) $200,001 or more.

    Measured: Parent report, collected over 30 minutes

  8. Parental Average Education Level. Potential Covariate

    Parents report education level for both parents on a 6-point ordinal scale: (1) Less than high school degree, (2) High school or GED, (3) Associate degree, college academia program, (4) Bachelor's degree, (5) Master's degree, (6) Professional and/or Doctorate degree. Average of parents' education is calculated and reported.

    Measured: Parent report, collected over 30 minutes

  9. Caffeine or Nicotine Within 1 Hour of Testing. Potential Covariate

    Youth report on whether they consumed caffeine or nicotine in the 1-2 hours prior to the assessment. Coded as no=0, yes=1. Used as a potential covariate for heart rate and neuroendocrine measures.

    Measured: Youth report, at start of 2 hour session

  10. Granger Score

    The Granger score (ordinal, modeled continuously) is a score based on work by Doug Granger of medications that can affect activity of the HPA axis, weighted by significance of potential impact (Granger, Hibel, Fortunato, \& Kapelewski, 2009). Each medication taken is given a score of 0, 1, or 2, and all medication scores for a participant is summed, resulting in scores from 0 to infinity. Lower scores are less likely to influence cortisol. Potential Covariate

    Measured: Youth report at the beginning of the 2 hour session

  11. Quality of Relationship With Primary Parent, BSV Positive Attachment Scale

    Network of Relationships Inventory (NRI) reported by youth for their primary parent on how much they experience various emotions or incidents (e.g. How much free time do you spend with this person?), reported on a 5-point scale: (1) Little or None, (2) Somewhat, (3) Very Much, (4) Extremely Much, (5) The Most. Mean scores calculated from all positive attachment items, range 1-5. Potential Covariate.

    Measured: Youth report, collected over course of 30 minutes

  12. Quality of Relationship With Close Friend, BSV Positive Attachment Scale

    Network of Relationships Inventory (NRI) reported by youth for their close friend on how much they experience various emotions or incidents (e.g. How much free time do you spend with this person?), reported on a 5-point scale: (1) Little or None, (2) Somewhat, (3) Very Much, (4) Extremely Much, (5) The Most. Mean scores calculated from all positive attachment items, ranging 1-5. Potential Covariate.

    Measured: Youth reported, collected over course of 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2019
  2. Study start18 Oct 2019
  3. Primary completion24 Jun 2023
  4. Study completion24 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04211155
Sponsor's protocol ID
STUDY00006378
Status last verified
Mar 2026
First submitted
7 Nov 2019
Last updated
30 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Questionnaires and MRI in people with Social Stress and Adolescent Behavior, run by University of Minnesota 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 3 inclusion and 11 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 30 Mar 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?

Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Cortisol AUCi (time frame: 2 hours, approx). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 30 Mar 2026.

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