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

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ClinicalTrials.gov Identifier: NCT04211155
Recruitment Status : Recruiting
First Posted : December 26, 2019
Last Update Posted : September 10, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief 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 social partners (e.g., experimenters).

Condition or disease Intervention/treatment Phase
Social Stress Adolescent Behavior Other: Questionnaires Other: MRI Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neural Correlates of the Shift in Social Buffering of Social Evaluative Threat in 11-14 Year Olds
Actual Study Start Date : October 18, 2019
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Primary Parent
Participants will be randomly assigned to one of 4 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, Experimenter, No Social Partner.
 Other: Questionnaires
The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.

Other: MRI
Within 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.
Experimental: Close Friend
Participants will be randomly assigned to one of 4 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, Experimenter, No Social Partner.
 Other: Questionnaires
The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.

Other: MRI
Within 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.
Experimental: Experimenter
Participants will be randomly assigned to one of 4 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, Experimenter, No Social Partner.
 Other: Questionnaires
The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.

Other: MRI
Within 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.
Experimental: No Social Partner
Participants will be randomly assigned to one of 4 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, Experimenter, No Social Partner.
 Other: Questionnaires
The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.

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


Outcome Measures
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Primary Outcome Measures :
  1. Change in Cortisol AUCi [ Time Frame: 2 hours ]
    8 samples will be taken during the course of the assessment. Area under the curve from initial (baseline) will be calculated and used in the analyses.

  2. Change Heart Rate Response [ Time Frame: 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 WHAT UNITS) 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.

  3. Dorsal anterior cingulate: Task-related brain activity (judged math vs. math alone) [ Time Frame: 2 hours ]
    The difference in fMRI signal intensity (unitless measure) in the bilateral dorsal anterior cingulate cortex (dACC) between the social evaluative stress condition (judged math performance) and the non-stress condition (math without judges).

  4. Left anterior insula: Task-related brain activity (judged math vs. math alone) [ Time Frame: 2 hours ]
    The difference in fMRI signal intensity (unitless measure) in the left anterior insula between the social evaluative stress condition (judged math performance) and the non-stress condition (math without judges).

  5. Right anterior insula: Task-related brain activity (judged math vs. math alone) [ Time Frame: 2 hours ]
    The difference in fMRI signal intensity (unitless measure) in the right anterior insula between the social evaluative stress condition (judged math performance) and the non-stress condition (math without judges).

  6. Ventromedial prefrontal cortex: Task-related brain activity (judged math vs. math alone) [ Time Frame: 2 hours ]
    The difference in fMRI signal intensity (unitless measure) in the bilateral ventromedial prefrontal cortex (vmPFC) between the social evaluative stress condition (judged math performance) and the non-stress condition (math without judges).

  7. Left dorsolateral prefrontal cortex: Task-related brain activity (judged math vs. math alone) [ Time Frame: 2 hours ]
    The difference in fMRI signal intensity (unitless measure) in the left dorsolateral prefrontal cortex (left dlPFC) between the social evaluative stress condition (judged math performance) and the non-stress condition (math without judges).

  8. Right dorsolateral prefrontal cortex: Task-related brain activity (judged math vs. math alone) [ Time Frame: 2 hours ]
    The difference in fMRI signal intensity (unitless measure) in the right dorsolateral prefrontal cortex (right dlPFC) between the social evaluative stress condition (judged math performance) and the non-stress condition (math without judges).

  9. Amygdala-vmPFC connectivity: fMRI functional connectivity (speech prep vs. rest) [ Time Frame: 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 functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

  10. Amygdala-left dlPFC connectivity: fMRI functional connectivity (speech prep vs. rest) [ Time Frame: 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 functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

  11. Amygdala-right dlPFC connectivity: fMRI functional connectivity (speech prep vs. rest) [ Time Frame: 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 functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

  12. Hypothalamus-vmPFC connectivity: fMRI functional connectivity (speech prep vs. rest) [ Time Frame: 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 functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

  13. Hypothalamus-left dlPFC connectivity: fMRI functional connectivity (speech vs. rest) [ Time Frame: 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 functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

  14. Hypothalamus-right dlPFC connectivity: fMRI functional connectivity (speech vs. rest) [ Time Frame: 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 functional connectivity value (r, or correlation coefficient) for each buffering condition/group.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • tattoos
  • history of significant claustrophobia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04211155


Contacts
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Contact: Bonny Donzella 6126244351 donzella@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Bonny Donzella    612-624-3315    donzella@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Megan Gunnar, PhD University of Minnesota
Principal Investigator: Kathleen Thomas, PhD University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04211155    
Other Study ID Numbers: STUDY00006378
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: September 10, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No