Clinical trial NCT04211155: Neural Correlates of the Shift in Social Buffering of Social Evaluative Threat
Official title: Neural Correlates of the Shift in Social Buffering of Social Evaluative Threat in 11-14 Year Olds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Stress
Adolescent Behavior
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 208
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 in response to social evaluative threat 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).

Detailed 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 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 the investigators completed over the phone). Girls will be shown to a changing room where the investigators will privately question them about any possibility of pregnancy. 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 also be able to see two judges and hear the judges instructions when the participant is in the scanning control room. The participant will then complete a variant or the Trier Social Stress Test, a social evaluative stressor, which produces elevations in heart rate and cortisol.

When saliva is collected, the scanning bed is withdrawn from the barrel of the MRI machine and the participant will be able to see and briefly interact with the social partner while saliva is sampled for steroid collection. Once the scan is over the participant will return to a waiting area and complete additional questionnaires, provide additional saliva samples, and another urine sample.

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, approx
measure: Change Heart Rate Response
timeFrame: 2 hours
measure: Dorsal Anterior Cingulate: Task-related Brain Activity (Judged Math vs. Math Alone)
timeFrame: 2 hours
measure: Left Anterior Insula: Task-related Brain Activity (Judged Math vs. Math Alone)
timeFrame: 2 hours
measure: Right Anterior Insula: Task-related Brain Activity (Judged Math vs. Math Alone)
timeFrame: 2 hours
measure: Ventromedial Prefrontal Cortex: Task-related Brain Activity (Judged Math vs. Math Alone)
timeFrame: 2 hours
measure: Left Dorsolateral Prefrontal Cortex: Task-related Brain Activity (Judged Math vs. Math Alone)
timeFrame: 2 hours
measure: Right Dorsolateral Prefrontal Cortex: Task-related Brain Activity (Judged Math vs. Math Alone)
timeFrame: 2 hours
measure: Amygdala-vmPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)
timeFrame: 2 hours
measure: Amygdala-left dlPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)
timeFrame: 2 hours
measure: Amygdala-right dlPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)
timeFrame: 2 hours
measure: Hypothalamus-vmPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)
timeFrame: 2 hours
measure: Hypothalamus-left dlPFC Connectivity: fMRI Functional Connectivity (Speech vs. Rest)
timeFrame: 2 hours
measure: Hypothalamus-right dlPFC Connectivity: fMRI Functional Connectivity (Speech vs. Rest)
timeFrame: 2 hours
measure: Change in Salivary Alpha Amylase, AUCi
timeFrame: 2 hours
Secondary outcomes:
measure: Self Report of Stress
timeFrame: 2 hours
measure: Peer Acceptance/Rejection
timeFrame: Parent report of child's general experience, collected over 30 minutes
measure: Behavioral Inhibition
timeFrame: Parent report of child's general experience, collected over 30 minutes
measure: Internalizing Symptoms
timeFrame: Parent report of child's general experience, collected over 30 minutes
measure: Externalizing Symptoms
timeFrame: Parent report of child's general experience, collected over 30 minutes
measure: Time Since Awakening
timeFrame: reported at the beginning of the 2 hour session
measure: Pretax Family Income. Potential Covariate
timeFrame: Parent report, collected over 30 minutes
measure: Parental Average Education Level. Potential Covariate
timeFrame: Parent report, collected over 30 minutes
measure: Caffeine or Nicotine Within 1 Hour of Testing. Potential Covariate
timeFrame: Youth report, at start of 2 hour session
measure: Granger Score
timeFrame: Youth report at the beginning of the 2 hour session
measure: Quality of Relationship With Primary Parent, BSV Positive Attachment Scale
timeFrame: Youth report, collected over course of 30 minutes
measure: Quality of Relationship With Close Friend, BSV Positive Attachment Scale
timeFrame: Youth reported, collected over course of 30 minutes
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: