Clinical trial NCT04312945: Affective Social Buffering
Official title: Affective Social Buffering
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Stress
Adolescent Behavior
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 187
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Cortisol AUCi
timeFrame: 2 hours
measure: Change Heart Rate Response
timeFrame: 2 hours
measure: Left amygdala: Task-related brain activity during Hariri Task
timeFrame: 2 hours
measure: Left amygdala: Task-related brain activity during IAPS GoNoGo Task
timeFrame: 2 hours
measure: Right amygdala: Task-related brain activity during Hariri Task
timeFrame: 2 hours
measure: Right amygdala: Task-related brain activity during IAPS GoNoGoTask
timeFrame: 2 hours
measure: Left insula: Task-related brain activity during Hariri Task
timeFrame: 2 hours
measure: Left insula: Task-related brain activity during IAPS GoNoGo Task
timeFrame: 2 hours
measure: Right insula: Task-related brain activity during Hariri Task
timeFrame: 2 hours
measure: Right insula: Task-related brain activity during IAPS GoNoGo Task
timeFrame: 2 hours
measure: Dorsomedial prefrontal cortex (dmPFC): Task-related brain activity during Hariri Task
timeFrame: 2 hours
measure: Dorsomedial prefrontal cortex (dmPFC): Task-related brain activity during IAPS GoNoGo Task
timeFrame: 2 hours
measure: Amygdala-vmPFC: Psychophysiological interaction (PPI) functional connectivity during Hariri Task
timeFrame: 2 hours
measure: Amygdala-vmPFC: Psychophysiological interaction (PPI) functional connectivity during IAPS GoNoGo Task
timeFrame: 2 hours
measure: Amygdala-dmPFC: Psychophysiological interaction (PPI) functional connectivity during Hariri Task
timeFrame: 2 hours
measure: Amygdala-dmPFC: Psychophysiological interaction (PPI) functional connectivity during IAPS GoNoGo Task
timeFrame: 2 hours
measure: Change in EDA during Hariri Task
timeFrame: 2 hours
measure: Change in EDA during IAPS GoNoGo Task
timeFrame: 2 hours
measure: EDA at Rest
timeFrame: 2 hours
Secondary outcomes:
measure: Change in Self Report of Stress
timeFrame: 2 hours
measure: Change in Accuracy during Hariri Task
timeFrame: 2 hours
measure: Change in Accuracy during IAPS GoNoGo Task
timeFrame: 2 hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Megan Gunnar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Kathleen Thomas, PhD
role: PRINCIPAL_INVESTIGATOR
References: