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Completed

NCT Number: NCT04312945

Affective Social Buffering

The purpose of this experiment is to determine the mechanisms through which parental buffering of stress physiology during affective stimulus presentation diminishes with pubertal development and whether this diminution of effectiveness extends to social buffering by peers (best friends), in comparison to a lack of social partners.

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Key information

Conditions

Social Stress Adolescent Behavior Behavior

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

On visit one, the participant will complete questionnaires, including ones on pubertal development, screening for MRI safety, and quality of relations with parents and friends.

Within 2 weeks the participant will return to the University where they will undergo the following protocol. Participants will be randomly assigned to one of 3 conditions that differ by who is with them in the scanner room: Primary Parent, Close Friend, 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 was completed over the phone). Females will be shown to a changing room where the investigators will privately question them about any possibility of pregnancy. 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. 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 then complete two emotionally evocative paradigms. The investigators will use a 3T Siemens Prisma scanner with a standard 32-channel phased array head coil.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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

MRI

Other

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

Primary outcomes

  1. Cortisol AUCi

    Time frame: 2 hours

    Area under the curve from initial (baseline) will be calculated and used in the analyses. Description = 7 saliva samples are collected during the course of the assessment. These samples are collected at (1) arrival for training purposes, (2) scan preparation, (3) entering scanner, (4) pre-Hariri task, (5) post-Hariri, pre-IAPS GoNoGo task, (6) exiting scanner, (7) departure. Area under the curve at intercept (AUCi) is calculated using sample 2 as the intercept. This AUCi calculation samples 2 to 7, spanning approximately 100 minutes.

  2. Change Heart Rate Response

    Time frame: period of resting state fMRI and period of emotional task fMRI (approximately 5 minutes after rest)

    Heart rate will be derived from the pulse-oximeter signal collected during periods of emotional affect and rest during the course of the assessment. The variable, heart rate response, is a numeric output (beats per minute) from validated software (BIOPAC). The outcome measure will be reported (in beats per minute) as the difference between heart rate response during the period of emotional affect and period of rest.

  3. Left Amygdala: Task-related Brain Activity During Hariri Task

    Time frame: during Hariri task fMRI scan (approx. 5 minute duration)

    The change in fMRI signal intensity in the left amygdala between the emotional and non-emotional stimuli during the task.

  4. Left Amygdala: Task-related Brain Activity During IAPS GoNoGo Task

    Time frame: during GoNoGo task fMRI scan (approx. 10 minute duration)

    The difference in fMRI signal intensity in the left amygdala between the negative affect and scrambled stimuli during the task.

  5. Right Amygdala: Task-related Brain Activity During Hariri Task

    Time frame: during Hariri task fMRI scan (approx. 5 minute duration)

    The change in fMRI signal intensity in the right amygdala between the emotional and non-emotional stimuli during the task.

  6. Right Amygdala: Task-related Brain Activity During IAPS GoNoGoTask

    Time frame: during GoNoGo task fMRI scan (approx. 10 minute duration)

    The difference in fMRI signal intensity in the right amygdala between the negative affect and scrambled stimuli during the task.

  7. Left Insula: Task-related Brain Activity During Hariri Task

    Time frame: during Hariri task fMRI scan (approx. 5 minute duration)

    The change in fMRI signal intensity in the left insula between the emotional and non-emotional stimuli during the task.

  8. Left Insula: Task-related Brain Activity During IAPS GoNoGo Task

    Time frame: during GoNoGo task fMRI scan (approx. 10 minute duration)

    The difference in fMRI signal intensity in the left insula between the negative affect and scrambled stimuli during the task.

  9. Right Insula: Task-related Brain Activity During Hariri Task

    Time frame: during Hariri task fMRI scan (approx. 5 minute duration)

    The change in fMRI signal intensity in the right insula between the emotional and non-emotional stimuli during the task.

  10. Right Insula: Task-related Brain Activity During IAPS GoNoGo Task

    Time frame: during GoNoGo task fMRI scan (approx. 10 minute duration)

    The difference in fMRI signal intensity in the right insula between the negative affect and scrambled stimuli during the task.

  11. Dorsomedial Prefrontal Cortex (dmPFC): Task-related Brain Activity During Hariri Task

    Time frame: during Hariri task fMRI scan (approx. 5 minute duration)

    The change in fMRI signal intensity in the bilateral dorsomedial prefrontal cortex (dmPFC) between the emotional and non-emotional stimuli during the task.

  12. Dorsomedial Prefrontal Cortex (dmPFC): Task-related Brain Activity During IAPS GoNoGo Task

    Time frame: during GoNoGo task fMRI scan (approx. 10 minute duration)

    The difference in fMRI signal intensity in the bilateral dorsomedial prefrontal cortex (dmPFC) between the negative affect and scrambled stimuli during the task.

  13. Amygdala-vmPFC: Psychophysiological Interaction (PPI) Functional Connectivity During Hariri Task

    Time frame: during Hariri task fMRI scan (approx. 5 minute duration)

    For each participant, blood oxygenation level dependent (BOLD) 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. An interaction analysis will be conducted to measure the effect of task condition on bilateral amygdala-vmPFC functional connectivity, which will be reported as a Z-score. A Z-score of zero indicates no difference in amygdala-vmPFC functional connectivity as a function of task. A more positive Z-score indicates increased amygdala-vmPFC functional connectivity during the emotional blocks of the task relative to the control blocks. A more negative Z-score indicates decreased amygdala-vmPFC functional connectivity during the emotional blocks of the task relative to the control blocks.

  14. Amygdala-vmPFC: Psychophysiological Interaction (PPI) Functional Connectivity During IAPS GoNoGo Task

    Time frame: during GoNoGo task fMRI scan (approx. 10 minute duration)

    For each participant, blood oxygenation level dependent (BOLD) signal intensity (unitless measure) will be measured using fMRI in the bilateral amygdala over a ten-minute recording period. Signal intensity will also be measured using fMRI in the ventromedial prefrontal cortex (vmPFC) over the same period of time. An interaction analysis will be conducted to measure the effect of task condition on bilateral amygdala-vmPFC functional connectivity, which will be reported as a Z-score. A Z-score of zero indicates no difference in amygdala-vmPFC functional connectivity as a function of task. A more positive Z-score indicates increased amygdala-vmPFC functional connectivity during the emotional blocks of the task relative to the control blocks. A more negative Z-score indicates decreased amygdala-vmPFC functional connectivity during the emotional blocks of the task relative to the control blocks.

  15. Amygdala-dmPFC: Psychophysiological Interaction (PPI) Functional Connectivity During Hariri Task

    Time frame: during Hariri task fMRI scan (approx. 5 minute duration)

    For each participant, blood oxygenation level dependent (BOLD) 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 dorsomedial prefrontal cortex (dmPFC) over the same period of time. An interaction analysis will be conducted to measure the effect of task condition on bilateral amygdala-dmPFC functional connectivity, which will be reported as a Z-score. A Z-score of zero indicates no difference in amygdala-dmPFC functional connectivity as a function of task. A more positive Z-score indicates increased amygdala-dmPFC functional connectivity during the emotional blocks of the task relative to the control blocks. A more negative Z-score indicates decreased amygdala-dmPFC functional connectivity during the emotional blocks of the task relative to the control blocks.

  16. Amygdala-dmPFC: Psychophysiological Interaction (PPI) Functional Connectivity During IAPS GoNoGo Task

    Time frame: during GoNoGo task fMRI scan (approx. 10 minute duration)

    For each participant, blood oxygenation level dependent (BOLD) signal intensity (unitless measure) will be measured using fMRI in the bilateral amygdala over a ten-minute recording period. Signal intensity will also be measured using fMRI in the dorsomedial prefrontal cortex (dmPFC) over the same period of time. An interaction analysis will be conducted to measure the effect of task condition on bilateral amygdala-dmPFC functional connectivity, which will be reported as a Z-score. A Z-score of zero indicates no difference in amygdala-dmPFC functional connectivity as a function of task. A more positive Z-score indicates increased amygdala-dmPFC functional connectivity during the emotional blocks of the task relative to the control blocks. A more negative Z-score indicates decreased amygdala-dmPFC functional connectivity during the emotional blocks of the task relative to the control blocks.

  17. Change in EDA During Hariri Task

    Time frame: during Hariri task fMRI scan (approx. 5 minute duration)

    The difference in mean amplitude EDA response between the emotional and non-emotional stimuli during the task.

  18. Change in EDA During IAPS GoNoGo Task

    Time frame: during GoNoGo task fMRI scan (approx. 10 minute duration)

    The difference in mean amplitude EDA response between the negative affect and scrambled stimuli during the task.

  19. EDA at Rest

    Time frame: during resting state fMRI scan (approx. 5 minute duration)

    EDA response amplitude during rest.

Secondary outcomes

  1. Change in Self Report of Stress

    Time frame: start of 2 hr testing session and period of emotional affect tasks (approx. 105 minutes after start)

    The Self Report of Stress is an 8-item questionnaire assessing participant level of stress at various time points across the session. Items are rated on a 5 point Likert scale. Total score is the unweighted mean of item scores. Total scores range from 0 to 40, with higher scores indicating greater stress. The assessment will be administered at baseline (no stress) and during a period of stress. The outcome will be reported as the difference between the baseline period and experimental stress period.

  2. Change in Accuracy During Hariri Task

    Time frame: during Hariri task fMRI scan (approx. 5 minute duration)

    Change in accuracy for stimulus matching between the emotional and non-emotional stimuli during the task.

  3. Change in Accuracy During IAPS GoNoGo Task

    Time frame: during GoNoGo task fMRI scan (approx. 10 minute duration)

    Change in accuracy of go/no go (press for go trials and no-press for no go trials) between the negative affect and scrambled stimuli during the task.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2020
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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