Affective Social Buffering

NCT04312945 | Completed Results

• 1 other identifier: STUDY00006378-2
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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 social partners.

Conditions

Social Stress; Adolescent Behavior

Outcome Measures

Primary Outcomes (19)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

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

• EDA at Rest

  EDA response amplitude during rest.

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

Secondary Outcomes (3)

• Change in Self Report of Stress

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

• Change in Accuracy During Hariri Task

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

• Change in Accuracy During IAPS GoNoGo Task

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

Study Arms (3)

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.

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.

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.

Other: Questionnaires; Other: MRI

Interventions

Questionnaires OTHER

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

Close Friend; No Social Partner; Primary Parent

MRI OTHER

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

Close Friend; No Social Partner; Primary Parent

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Adolescent Behavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Bonny Donzella
• Organization: University of Minnesota

donzella@umn.edu

6126244351

Study Officials

• Megan Gunnar, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Kathleen Thomas, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 18, 2020
• Study Start: July 17, 2023
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2026-01

Locations

US (1)