N/A N=208 Randomized Basic Science

Neural Correlates of the Shift in Social Buffering of Social Evaluative Threat

Social Stress · Adolescent Behavior

Bottom Line

View on ClinicalTrials.gov: NCT04211155 ↗

Enrolled (actual)

208

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Change in Cortisol AUCi — -0.04; 0.02; -0.01 (ug/dl)*minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Questionnaires (Other); MRI (Other)
Age: Pediatric · 11+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Cortisol AUCi	-0.04; 0.02; -0.01	—
PRIMARY Change Heart Rate Response	6.09; 4.82; 4.18	—
PRIMARY Dorsal Anterior Cingulate: Task-related Brain Activity (Judged Math vs. Math Alone)	0.07369; 0.09059; 0.1669	—
PRIMARY Left Anterior Insula: Task-related Brain Activity (Judged Math vs. Math Alone)	0.06186; 0.0807; 0.1336	—
PRIMARY Right Anterior Insula: Task-related Brain Activity (Judged Math vs. Math Alone)	0.02742; 0.05733; 0.09256	—
PRIMARY Ventromedial Prefrontal Cortex: Task-related Brain Activity (Judged Math vs. Math Alone)	0.02742; 0.05733; 0.09256	—
PRIMARY Left Dorsolateral Prefrontal Cortex: Task-related Brain Activity (Judged Math vs. Math Alone)	0.11; 0.08843; 0.1492	—
PRIMARY Right Dorsolateral Prefrontal Cortex: Task-related Brain Activity (Judged Math vs. Math Alone)	0.05686; 0.06929; 0.1659	—
PRIMARY Amygdala-vmPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)	0.0225; -0.0180; 0.0131	—
PRIMARY Amygdala-left dlPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)	0.0332; -0.0492; -0.0263	—
PRIMARY Amygdala-right dlPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)	0.0548; 0.0716; 0.1069	—
PRIMARY Hypothalamus-vmPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)	0.0079; 0.0424; 0.0416	—
PRIMARY Hypothalamus-left dlPFC Connectivity: fMRI Functional Connectivity (Speech vs. Rest)	0.0269; -0.0068; 0.0010	—
PRIMARY Hypothalamus-right dlPFC Connectivity: fMRI Functional Connectivity (Speech vs. Rest)	-0.0318; 0.0109; 0.0058	—
PRIMARY Change in Salivary Alpha Amylase, AUCi	4.77; 6.76; 6.32	—
SECONDARY Self Report of Stress	1.74; 1.5; 1.81	—
SECONDARY Peer Acceptance/Rejection	3.55; 3.54; 3.51	—
SECONDARY Behavioral Inhibition	0.64; 0.7; 0.69	—
SECONDARY Internalizing Symptoms	0.24; 0.24; 0.25	—
SECONDARY Externalizing Symptoms	0.13; 0.12; 0.07	—
SECONDARY Time Since Awakening	7.92; 8.15; 8.58	—
SECONDARY Pretax Family Income. Potential Covariate	9; 8; 8	—
SECONDARY Parental Average Education Level. Potential Covariate	4.5; 4.5; 4.5	—
SECONDARY Caffeine or Nicotine Within 1 Hour of Testing. Potential Covariate	0; 0; 0	—
SECONDARY Granger Score	0.03; 0.19; 0.11	—
SECONDARY Quality of Relationship With Primary Parent, BSV Positive Attachment Scale	3.25; 3.12; 3.15	—
SECONDARY Quality of Relationship With Close Friend, BSV Positive Attachment Scale	3.36; 3.37; 3.43	—

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04211155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.