Social Buffering During Aversive Conditioning

Adolescent Behavior Clinical Trial

Official title:

Social Buffering During Aversive Conditioning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04312945
• Other study ID #: STUDY00006378-2
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: July 2023
• Source: University of Minnesota
• Contact: Bonny Donzella
• Phone: 6126244351
• Email: donzella[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this experiment is to determine the mechanisms through which parental buffering of stress physiology during aversive conditioning diminishes with pubertal development and whether this diminution of effectiveness extends to social buffering by peers (best friends) and/or other unfamiliar social partners (e.g., experimenters).

Description:

On visit one, the participant will 1) be seen by a nurse who will complete a pubertal assessment exam, 2) complete questionnaires, including ones on pubertal development, screening for MRI safety, and quality of relations with parents and friends. The participant will also have a chance to experience a simulated MRI in order to determine whether they will be comfortable in an actual MRI.

Within 2 weeks the participant will return to the University where they will undergo the following protocol. Participants will be randomly assigned to one of 4 conditions that differ by who is with them in the scanner room: Primary Parent, Close Friend, Experimenter, No Social Partner. (N=50 per condition, 25 male, 25 female).

Once at the Center for Magnetic Resonance Research, participants and the individual who will be with the participant in the scanning room will undergo an MRI safety screening (the repeat of what was completed over the phone). Girls will be shown to a changing room where the investigators will privately question them about any possibility of pregnancy. All participants will provide a urine sample for oxytocin assessment. Then 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 aversive (fear) conditioning paradigms, none using a social and one using a non-social stimulus. The investigators will use a 3T Siemens Prisma scanner with a standard 32-channel phased array head coil.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Social Stress

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cortisol AUCi	8 samples will be taken during the course of the assessment. Area under the curve from initial (baseline) will be calculated and used in the analyses.	2 hours
Primary	Change Heart Rate Response	Heart rate will be derived from the EKG signal collected during periods of stress (social evaluation) and non-stress (no evaluation) during the course of the assessment. The variable, heart rate response, is a numeric output (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 stress and period of non-stress.	2 hours
Primary	Left amygdala: Task-related brain activity during threat conditioning	The difference in fMRI signal intensity (unitless measure) in the left amygdala between the threat and safety cues during the acquisition of conditioned threat.	2 hours
Primary	Right amygdala: Task-related brain activity during threat conditioning	The difference in fMRI signal intensity (unitless measure) in the right amygdala between the threat and safety cues during the acquisition of conditioned threat.	2 hours
Primary	Left insula: Task-related brain activity during threat conditioning	The difference in fMRI signal intensity (unitless measure) in the left insula between the threat and safety cues during the acquisition of conditioned threat.	2 hours
Primary	Right insula: Task-related brain activity during threat conditioning	The difference in fMRI signal intensity (unitless measure) in the right insula between the threat and safety cues during the acquisition of conditioned threat.	2 hours
Primary	Dorsomedial prefrontal cortex (dmPFC): Task-related brain activity during threat conditioning	The difference in fMRI signal intensity (unitless measure) in the bilateral dorsomedial prefrontal cortex (dmPFC) between the threat and safety cues during the acquisition of conditioned threat.	2 hours
Primary	Amygdala-vmPFC by Task: Psychophysiological interaction (PPI) functional connectivity during threat conditioning	For each participant, signal intensity (unitless measure) will be measured using fMRI in the bilateral amygdala over a five-minute recording period. Signal intensity will also be measured using fMRI in the ventromedial prefrontal cortex (vmPFC) over the same period of time. A bivariate correlation will be conducted for these two data sets to determine functional connectivity, which will be reported as the r value of the correlation. This outcome measure will be reported as the mean functional connectivity value (r, or correlation coefficient) for each task condition/group.	2 hours
Primary	Amygdala-dmPFC by Task: Psychophysiological interaction (PPI) functional connectivity during threat conditioning	For each participant, signal intensity (unitless measure) will be measured using fMRI in the bilateral amygdala over a five-minute recording period. Signal intensity will also be measured using fMRI in the bilateral dorsomedial prefrontal cortex (dmPFC) over the same period of time. A bivariate correlation will be conducted for these two data sets to determine functional connectivity, which will be reported as the r value of the correlation. This outcome measure will be reported as the mean functional connectivity value (r, or correlation coefficient) for each task condition/group.	2 hours
Primary	Conditioning Effect: Stimulus valence	Conditioning effect will be measured as the difference in self-reported stimulus valence, defined as pleasure or aversion to the study stimulus, between CS+ and CS- tasks over time. Stimulus valence will be measured on a 5-point Likert scale for each of 40-50 trials for each the CS+ and CS+ conditions. The mean of all CS+ trials and CS- trials is calculated and outcome is reported has the difference between the two.	2 hours
Primary	Conditioning Effect: Stimulus arousal	Conditioning effect will be measured as the difference in self-reported stimulus arousal, defined as the intensity of pleasure or aversion to the study stimulus, between CS+ and CS- tasks over time. Stimulus arousal will be measured on a 5-point Likert scale for each of 40-50 trials for each the CS+ and CS+ conditions. The mean of all CS+ trials and CS- trials is calculated and outcome is reported has the difference between the two.	2 hours
Primary	Conditioning Effect: Mean Unconditioned Stimulus (UCS) expectancy	Conditioning effect will be measured as the difference in self-reported UCS expectancy, defined as how likely a task is to cause pleasure or aversion, between CS+ and CS- tasks over time. Stimulus arousal will be measured on a 7-point Likert scale for each of 40-50 trials for each the CS+ and CS+ conditions. The mean of all CS+ trials and CS- trials is calculated and outcome is reported has the difference between the two.	2 hours
Secondary	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.	2 hours