Social StressNCT04312945

Affective Social Buffering

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 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… 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: 202 participants
Where: 1 siteUnited States
Study dates: 17 Jul 2023to 17 Feb 2025
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

Read the detailed description

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.

Conditions: Social Stress, Adolescent Behavior
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 NCT04312945
Study group	Role	What they receive
Primary Parent	Experimental	Participants will be randomly assigned to one of 3 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, No Social Partner. In this case, the primary parent was present in the MRI room during the assessment. Receives: Other: Questionnaires; Other: MRI
Close Friend	Experimental	Participants will be randomly assigned to one of 3 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend,No Social Partner. In this case, the close friend was present in the MRI room during the assessment. Receives: Other: Questionnaires; Other: MRI
No Social Partner	Experimental	Participants will be randomly assigned to one of 3 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, No Social Partner. In this case, no social partner was present in the MRI room during the assessment. Receives: Other: Questionnaires; Other: MRI

What is being measured

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

Cortisol AUCi
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.
Measured: 2 hours
Change Heart Rate Response
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.
Measured: period of resting state fMRI and period of emotional task fMRI (approximately 5 minutes after rest)
Left Amygdala: Task-related Brain Activity During Hariri Task
The change in fMRI signal intensity in the left amygdala between the emotional and non-emotional stimuli during the task.
Measured: during Hariri task fMRI scan (approx. 5 minute duration)
Left Amygdala: Task-related Brain Activity During IAPS GoNoGo Task
The difference in fMRI signal intensity in the left amygdala between the negative affect and scrambled stimuli during the task.
Measured: during GoNoGo task fMRI scan (approx. 10 minute duration)
Right Amygdala: Task-related Brain Activity During Hariri Task
The change in fMRI signal intensity in the right amygdala between the emotional and non-emotional stimuli during the task.
Measured: during Hariri task fMRI scan (approx. 5 minute duration)
Right Amygdala: Task-related Brain Activity During IAPS GoNoGoTask
The difference in fMRI signal intensity in the right amygdala between the negative affect and scrambled stimuli during the task.
Measured: during GoNoGo task fMRI scan (approx. 10 minute duration)
Left Insula: Task-related Brain Activity During Hariri Task
The change in fMRI signal intensity in the left insula between the emotional and non-emotional stimuli during the task.
Measured: during Hariri task fMRI scan (approx. 5 minute duration)
Left Insula: Task-related Brain Activity During IAPS GoNoGo Task
The difference in fMRI signal intensity in the left insula between the negative affect and scrambled stimuli during the task.
Measured: during GoNoGo task fMRI scan (approx. 10 minute duration)
Right Insula: Task-related Brain Activity During Hariri Task
The change in fMRI signal intensity in the right insula between the emotional and non-emotional stimuli during the task.
Measured: during Hariri task fMRI scan (approx. 5 minute duration)
Right Insula: Task-related Brain Activity During IAPS GoNoGo Task
The difference in fMRI signal intensity in the right insula between the negative affect and scrambled stimuli during the task.
Measured: during GoNoGo task fMRI scan (approx. 10 minute duration)
Dorsomedial Prefrontal Cortex (dmPFC): Task-related Brain Activity During Hariri Task
The change in fMRI signal intensity in the bilateral dorsomedial prefrontal cortex (dmPFC) between the emotional and non-emotional stimuli during the task.
Measured: during Hariri task fMRI scan (approx. 5 minute duration)
Dorsomedial Prefrontal Cortex (dmPFC): Task-related Brain Activity During IAPS GoNoGo Task
The difference in fMRI signal intensity in the bilateral dorsomedial prefrontal cortex (dmPFC) between the negative affect and scrambled stimuli during the task.
Measured: during GoNoGo task fMRI scan (approx. 10 minute duration)
Amygdala-vmPFC: Psychophysiological Interaction (PPI) Functional Connectivity During Hariri Task
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.
Measured: during Hariri task fMRI scan (approx. 5 minute duration)
Amygdala-vmPFC: Psychophysiological Interaction (PPI) Functional Connectivity During IAPS GoNoGo Task
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.
Measured: during GoNoGo task fMRI scan (approx. 10 minute duration)
Amygdala-dmPFC: Psychophysiological Interaction (PPI) Functional Connectivity During Hariri Task
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.
Measured: during Hariri task fMRI scan (approx. 5 minute duration)
Amygdala-dmPFC: Psychophysiological Interaction (PPI) Functional Connectivity During IAPS GoNoGo Task
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.
Measured: during GoNoGo task fMRI scan (approx. 10 minute duration)
Change in EDA During Hariri Task
The difference in mean amplitude EDA response between the emotional and non-emotional stimuli during the task.
Measured: during Hariri task fMRI scan (approx. 5 minute duration)
Change in EDA During IAPS GoNoGo Task
The difference in mean amplitude EDA response between the negative affect and scrambled stimuli during the task.
Measured: during GoNoGo task fMRI scan (approx. 10 minute duration)
EDA at Rest
EDA response amplitude during rest.
Measured: during resting state fMRI scan (approx. 5 minute duration)

Secondary outcomes (3)

Change in Self Report of Stress
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.
Measured: start of 2 hr testing session and period of emotional affect tasks (approx. 105 minutes after start)
Change in Accuracy During Hariri Task
Change in accuracy for stimulus matching between the emotional and non-emotional stimuli during the task.
Measured: during Hariri task fMRI scan (approx. 5 minute duration)
Change in Accuracy During IAPS GoNoGo Task
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.
Measured: during GoNoGo task fMRI scan (approx. 10 minute duration)

Timeline

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

17 Jul 202317 Feb 2025

First posted18 Mar 2020
Study start17 Jul 2023
Primary completion17 Feb 2025
Study completion17 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Social StressStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04312945
Sponsor's protocol ID: STUDY00006378-2
Status last verified: Jan 2026
First submitted: 13 Mar 2020
Last updated: 23 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Gardening Activities, Stress, and Social Interaction Among University Students
Psychosocial Wellbeing, Perceived Stress
RecruitingObservational study
Geospatial Analysis of Neighborhood Environmental Stress in Relation to Biological Markers of Cardiovascular Health and Health Behaviors in Women
Cardiovascular (CV) Risk
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications
Active, not recruiting
Manage Emotions to Reduce Aggression (MERA)
Stress Disorders, Post-Traumatic, Aggression
Active, not recruiting
Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
Safety, Psychological, Acceptability of Health Care

All Social Stress trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Affective Social Buffering
ClinicalTrials.gov ID: NCT04312945
Acronym / sponsor ID: STUDY00006378-2
Conditions: Social Stress, Adolescent Behavior
Study type: Interventional
Recruitment status: Completed
Enrolment: 202 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: 17 Jul 2023 (actual)
Primary completion: 17 Feb 2025 (actual)
Study completion: 17 Feb 2025 (actual)
First posted: 18 Mar 2020 (actual)
Results: Posted 23 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Primary Parent	Experimental	Other: Questionnaires, Other: MRIParticipants will be randomly assigned to one of 3 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, No Social Partner. In this case, the primary parent was present in the MRI room during the assessment.
Close Friend	Experimental	Other: Questionnaires, Other: MRIParticipants will be randomly assigned to one of 3 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend,No Social Partner. In this case, the close friend was present in the MRI room during the assessment.
No Social Partner	Experimental	Other: Questionnaires, Other: MRIParticipants will be randomly assigned to one of 3 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, No Social Partner. In this case, no social partner was present in the MRI room during the assessment.

Who may qualify

Ages: 11 to 14 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QuestionnairesThe participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.	Other	Close Friend, No Social Partner, Primary Parent
MRIWithin 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.	Other	Close Friend, No Social Partner, Primary Parent

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
EDA at Rest
Time frame: during resting state fMRI scan (approx. 5 minute duration)
EDA response amplitude during rest.

3 secondary outcomes

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)
Change in Accuracy During Hariri Task
Time frame: during Hariri task fMRI scan (approx. 5 minute duration)
Change in Accuracy During IAPS GoNoGo Task
Time frame: during GoNoGo task fMRI scan (approx. 10 minute duration)

Results and safety

Results posted to the registry on 23 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Parent	69	64
Close Friend	69	66
No Social Partner	64	63

Primary outcome: Cortisol AUCi

Time frame: 2 hours. Mean (Standard Deviation). Unit: (ug/dL)*minutes

Measure	Primary Parent n = 57	Close Friend n = 56	No Social Partner n = 54
Value	-93.6397 (182.94398)	-68.0959 (239.64667)	-106.9105 (227.39856)

Population analysed: 193 participants were completed, with 63 Alone, 64 Parent, and 66 Friend. For each outcome, all available analyzable data were included in results, sometimes resulting in lower n.

Primary outcome: Change Heart Rate Response

Time frame: period of resting state fMRI and period of emotional task fMRI (approximately 5 minutes after rest). Mean (Standard Deviation). Unit: beats per minute

Measure	Primary Parent n = 26	Close Friend n = 28	No Social Partner n = 32
Value	.543 (3.818)	.707 (2.418)	1.343 (3.106)

Primary outcome: Left Amygdala: Task-related Brain Activity During Hariri Task

Time frame: during Hariri task fMRI scan (approx. 5 minute duration). Mean (Standard Deviation). Unit: % change in BOLD signal

Measure	Primary Parent n = 56	Close Friend n = 53	No Social Partner n = 55
Value	0.231 (0.136)	0.245 (0.153)	0.232 (0.151)

Primary outcome: Left Amygdala: Task-related Brain Activity During IAPS GoNoGo Task

Time frame: during GoNoGo task fMRI scan (approx. 10 minute duration). Mean (Standard Deviation). Unit: % change in BOLD signal

Measure	Primary Parent n = 54	Close Friend n = 51	No Social Partner n = 56
Value	0.28073 (.15741)	.29334 (.18174)	.29397 (.15677)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: during testing session, 2 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary Parent	0 of 64 (0%)	0 of 64 (0%)	0 of 64
Close Friend	0 of 66 (0%)	0 of 66 (0%)	0 of 66
No Social Partner	0 of 63 (0%)	0 of 63 (0%)	0 of 63

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Social Stress

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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Megan Gunnar, PhD principal investigator

University of Minnesota

Kathleen Thomas, PhD principal investigator

University of Minnesota

1 site in 1 country: see every site and its status.

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 23 Jan 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 23 Jan 2026). 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?

Cortisol AUCi (time frame: 2 hours). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04312945.

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 23 Jan 2026.