Trial Outcomes & Findings for Affective Social Buffering (NCT NCT04312945)

NCT ID: NCT04312945

Last Updated: 2026-01-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 202 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2026-01-23

Participant Flow

Participant milestones

Measure	Primary Parent 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, participants will complete the assessment with the primary parent in the MRI room.	Close Friend 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, participants will complete the assessment with their close friend in the MRI room.	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, Close Friend, No Social Partner. In this case, participants will complete the assessment with no social partner in the MRI room.
Overall Study STARTED	69	69	64
Overall Study COMPLETED	64	66	63
Overall Study NOT COMPLETED	5	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Affective Social Buffering

Baseline characteristics by cohort

Measure	No Social Partner n=63 Participants 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. Questionnaires: The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends. MRI: Within 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.	Primary Parent n=64 Participants 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. Questionnaires: The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends. MRI: Within 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.	Close Friend n=66 Participants 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. Questionnaires: The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends. MRI: Within 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.	Total n=193 Participants Total of all reporting groups
Sex: Female, Male Male	33 Participants n=270 Participants	32 Participants n=4 Participants	34 Participants n=9 Participants	99 Participants n=220 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=270 Participants	1 Participants n=4 Participants	0 Participants n=9 Participants	1 Participants n=220 Participants
Race (NIH/OMB) Asian	3 Participants n=270 Participants	2 Participants n=4 Participants	2 Participants n=9 Participants	7 Participants n=220 Participants
Age, Categorical <=18 years	63 Participants n=270 Participants	64 Participants n=4 Participants	66 Participants n=9 Participants	193 Participants n=220 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants
Age, Categorical >=65 years	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants
Sex: Female, Male Female	30 Participants n=270 Participants	32 Participants n=4 Participants	32 Participants n=9 Participants	94 Participants n=220 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants	0 Participants n=4 Participants	0 Participants n=9 Participants	0 Participants n=220 Participants
Race (NIH/OMB) Black or African American	1 Participants n=270 Participants	3 Participants n=4 Participants	1 Participants n=9 Participants	5 Participants n=220 Participants
Race (NIH/OMB) White	54 Participants n=270 Participants	51 Participants n=4 Participants	55 Participants n=9 Participants	160 Participants n=220 Participants
Race (NIH/OMB) More than one race	5 Participants n=270 Participants	6 Participants n=4 Participants	8 Participants n=9 Participants	19 Participants n=220 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants	1 Participants n=4 Participants	0 Participants n=9 Participants	1 Participants n=220 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=270 Participants	4 Participants n=4 Participants	5 Participants n=9 Participants	14 Participants n=220 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	58 Participants n=270 Participants	60 Participants n=4 Participants	59 Participants n=9 Participants	177 Participants n=220 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants	0 Participants n=4 Participants	2 Participants n=9 Participants	2 Participants n=220 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: 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.

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.

Outcome measures

Measure	Close Friend n=56 Participants 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.	No Social Partner n=54 Participants 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.	Primary Parent n=57 Participants 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.
Cortisol AUCi	-68.0959 (ug/dL)*minutes Standard Deviation 239.64667	-106.9105 (ug/dL)*minutes Standard Deviation 227.39856	-93.6397 (ug/dL)*minutes Standard Deviation 182.94398

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Close Friend n=28 Participants 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.	No Social Partner n=32 Participants 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.	Primary Parent n=26 Participants 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.
Change Heart Rate Response	.707 beats per minute Standard Deviation 2.418	1.343 beats per minute Standard Deviation 3.106	.543 beats per minute Standard Deviation 3.818

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Measure	Close Friend n=53 Participants 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.	No Social Partner n=55 Participants 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.	Primary Parent n=56 Participants 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.
Left Amygdala: Task-related Brain Activity During Hariri Task	0.245 % change in BOLD signal Standard Deviation 0.153	0.232 % change in BOLD signal Standard Deviation 0.151	0.231 % change in BOLD signal Standard Deviation 0.136

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Measure	Close Friend n=51 Participants 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.	No Social Partner n=56 Participants 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.	Primary Parent n=54 Participants 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.
Left Amygdala: Task-related Brain Activity During IAPS GoNoGo Task	.29334 % change in BOLD signal Standard Deviation .18174	.29397 % change in BOLD signal Standard Deviation .15677	0.28073 % change in BOLD signal Standard Deviation .15741

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Measure	Close Friend n=53 Participants 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.	No Social Partner n=55 Participants 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.	Primary Parent n=56 Participants 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.
Right Amygdala: Task-related Brain Activity During Hariri Task	0.273 % change in BOLD signal Standard Deviation 0.164	0.297 % change in BOLD signal Standard Deviation 0.151	0.275 % change in BOLD signal Standard Deviation 0.140

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Measure	Close Friend n=51 Participants 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.	No Social Partner n=56 Participants 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.	Primary Parent n=54 Participants 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.
Right Amygdala: Task-related Brain Activity During IAPS GoNoGoTask	0.29021 % change in BOLD signal Standard Deviation 0.18815	0.33038 % change in BOLD signal Standard Deviation 0.15398	0.30121 % change in BOLD signal Standard Deviation 0.19301

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Measure	Close Friend n=53 Participants 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.	No Social Partner n=55 Participants 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.	Primary Parent n=56 Participants 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.
Left Insula: Task-related Brain Activity During Hariri Task	0.0007 % change in BOLD signal Standard Deviation 0.153	-0.018 % change in BOLD signal Standard Deviation 0.129	-0.008 % change in BOLD signal Standard Deviation 0.124

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Measure	Close Friend n=51 Participants 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.	No Social Partner n=56 Participants 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.	Primary Parent n=54 Participants 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.
Left Insula: Task-related Brain Activity During IAPS GoNoGo Task	.02078 % change in BOLD signal Standard Deviation .15591	.00809 % change in BOLD signal Standard Deviation .15488	.01627 % change in BOLD signal Standard Deviation .14347

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Measure	Close Friend n=53 Participants 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.	No Social Partner n=55 Participants 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.	Primary Parent n=56 Participants 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.
Right Insula: Task-related Brain Activity During Hariri Task	0.0004 % change in BOLD signal Standard Deviation 0.144	-0.017 % change in BOLD signal Standard Deviation 0.100	-0.012 % change in BOLD signal Standard Deviation 0.136

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Measure	Close Friend n=51 Participants 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.	No Social Partner n=56 Participants 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.	Primary Parent n=54 Participants 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.
Right Insula: Task-related Brain Activity During IAPS GoNoGo Task	.01356 % change in BOLD signal Standard Deviation .18215	-0.00077 % change in BOLD signal Standard Deviation .12285	.01504 % change in BOLD signal Standard Deviation .14045

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Measure	Close Friend n=53 Participants 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.	No Social Partner n=55 Participants 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.	Primary Parent n=56 Participants 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.
Dorsomedial Prefrontal Cortex (dmPFC): Task-related Brain Activity During Hariri Task	0.093 % change in BOLD signal Standard Deviation 0.218	0.108 % change in BOLD signal Standard Deviation 0.227	0.048 % change in BOLD signal Standard Deviation 0.190

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Measure	Close Friend n=51 Participants 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.	No Social Partner n=56 Participants 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.	Primary Parent n=54 Participants 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.
Dorsomedial Prefrontal Cortex (dmPFC): Task-related Brain Activity During IAPS GoNoGo Task	.02385 % change in BOLD signal Standard Deviation .20474	.00827 % change in BOLD signal Standard Deviation .17163	.02224 % change in BOLD signal Standard Deviation .20273

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Close Friend n=53 Participants 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.	No Social Partner n=55 Participants 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.	Primary Parent n=56 Participants 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.
Amygdala-vmPFC: Psychophysiological Interaction (PPI) Functional Connectivity During Hariri Task	-0.033 Z-score Standard Deviation 0.428	0.116 Z-score Standard Deviation 0.445	-0.033 Z-score Standard Deviation 0.453

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Close Friend n=50 Participants 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.	No Social Partner n=56 Participants 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.	Primary Parent n=54 Participants 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.
Amygdala-vmPFC: Psychophysiological Interaction (PPI) Functional Connectivity During IAPS GoNoGo Task	.01399 Z-score Standard Deviation .53853	-0.01128 Z-score Standard Deviation .49507	-0.11810 Z-score Standard Deviation .54062

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Close Friend n=53 Participants 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.	No Social Partner n=55 Participants 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.	Primary Parent n=56 Participants 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.
Amygdala-dmPFC: Psychophysiological Interaction (PPI) Functional Connectivity During Hariri Task	0.127 Z-score Standard Deviation 0.321	0.072 Z-score Standard Deviation 0.393	0.055 Z-score Standard Deviation 0.326

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Close Friend n=50 Participants 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.	No Social Partner n=56 Participants 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.	Primary Parent n=54 Participants 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.
Amygdala-dmPFC: Psychophysiological Interaction (PPI) Functional Connectivity During IAPS GoNoGo Task	.008081 Z-score Standard Deviation .30828	.04997 Z-score Standard Deviation .37726	.01220 Z-score Standard Deviation .43335

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Measure	Close Friend n=22 Participants 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.	No Social Partner n=23 Participants 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.	Primary Parent n=25 Participants 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.
Change in EDA During Hariri Task	.000659 microSiemens Standard Deviation .0089826	-0.01369 microSiemens Standard Deviation .0190926	.001569 microSiemens Standard Deviation .0221798

PRIMARY outcome

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

Population: 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.

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

Outcome measures

Measure	Close Friend n=23 Participants 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.	No Social Partner n=33 Participants 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.	Primary Parent n=24 Participants 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.
Change in EDA During IAPS GoNoGo Task	.003808 microSiemens Standard Deviation .0106093	.000465 microSiemens Standard Deviation .0141820	.002348 microSiemens Standard Deviation .0208932

PRIMARY outcome

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

Population: 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.

EDA response amplitude during rest.

Outcome measures

Measure	Close Friend n=26 Participants 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.	No Social Partner n=31 Participants 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.	Primary Parent n=28 Participants 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.
EDA at Rest	.0273 microSiemens Standard Deviation .01586	.0287 microSiemens Standard Deviation .02013	.0269 microSiemens Standard Deviation .01828

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Close Friend n=60 Participants 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.	No Social Partner n=59 Participants 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.	Primary Parent n=60 Participants 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.
Change in Self Report of Stress	.4500 scores on a scale Standard Deviation 1.20978	.3305 scores on a scale Standard Deviation 1.0692	0.0000 scores on a scale Standard Deviation .4500

SECONDARY outcome

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

Population: 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.

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

Outcome measures

Measure	Close Friend n=60 Participants 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.	No Social Partner n=59 Participants 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.	Primary Parent n=60 Participants 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.
Change in Accuracy During Hariri Task	-25.37 % change in accuracy Standard Deviation 24.261	-25.31 % change in accuracy Standard Deviation 19.498	-25.27 % change in accuracy Standard Deviation 16.717

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Close Friend n=59 Participants 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.	No Social Partner n=58 Participants 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.	Primary Parent n=59 Participants 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.
Change in Accuracy During IAPS GoNoGo Task	-0.86 % change in accuracy Standard Deviation 6.311	-2.50 % change in accuracy Standard Deviation 5.269	-2.01 % change in accuracy Standard Deviation 6.129

Adverse Events

Primary Parent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Close Friend

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Social Partner

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bonny Donzella

University of Minnesota

Phone: 6126244351

Email: donzella@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place