NCT04211155

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2023

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 27, 2025

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

3.7 years

First QC Date

November 7, 2019

Results QC Date

June 3, 2024

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (15)

  • Change in Cortisol AUCi

    Area under the curve from initial (baseline) will be calculated and used in the analyses. Description = 9 saliva samples are collected during the course of the assessment. These samples are collected at (1) arrival for training purposes; T=0, (2) scan preparation; T=35 minutes, (3) entering scanner; T=55 minutes, (4) pre-TSST; T=75 minutes, (5) post-TSST; T=100 minutes, (6) pre-math alone; T=110 minutes, (7) post-math alone; T=120 minutes, (8) exiting scanner; T=130 minutes, (9) departure; T=140 minutes. Area under the curve at intercept (AUCi) is calculated using samples 2-7 with sample 2 as the intercept.

    2 hours, approx

  • 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 (reported in beats per minutes) from validated software (BIOPAC) which is calculated using a regression algorithm. The outcome measure will be reported as the difference between heart rate response during the period of stress and period of non-stress.

    2 hours

  • Dorsal Anterior Cingulate: Task-related Brain Activity (Judged Math vs. Math Alone)

    The difference in fMRI BOLD signal intensity in the bilateral dorsal anterior cingulate cortex (dACC) between the social evaluative stress condition (judged math) and non-stress condition (math without judges). Mean group differences in signal intensity between the two math tasks were extracted from a brain region defined by the Harvard-Oxford brain atlas anterior cingulate cortex thresholded at 50% confidence and dorsal to the genu of the corpus callosum.

    2 hours

  • Left Anterior Insula: Task-related Brain Activity (Judged Math vs. Math Alone)

    The difference in fMRI BOLD signal intensity in the left anterior insula between the social evaluative stress condition (judged math) and non-stress condition (math without judges). Mean group differences in signal intensity between the two math tasks were extracted from a brain region defined by the Harvard-Oxford brain atlas left insula thresholded at 50% confidence and anterior to the region's midpoint.

    2 hours

  • Right Anterior Insula: Task-related Brain Activity (Judged Math vs. Math Alone)

    The difference in fMRI BOLD signal intensity in the right anterior insula between the social evaluative stress condition (judged math) and non-stress condition (math without judges). Mean group differences in signal intensity between the two math tasks were extracted from a brain region defined by the Harvard-Oxford brain atlas right insula thresholded at 50% confidence and anterior to the region's midpoint.

    2 hours

  • Ventromedial Prefrontal Cortex: Task-related Brain Activity (Judged Math vs. Math Alone)

    The difference in fMRI BOLD signal intensity in the bilateral ventromedial prefrontal cortex (vmPFC) between the social evaluative stress condition (judged math) and non-stress condition (math without judges). Mean group differences in signal intensity between the two math tasks were extracted from a brain region defined by the combination of Harvard-Oxford brain atlas frontal pole, frontal medial cortex, and subcallosal cortex thresholded at 50% confidence and ventral to the genu of the corpus callosum and medial to the lateral edges of the Harvard-Oxford brain atlas frontal medial cortex.

    2 hours

  • Left Dorsolateral Prefrontal Cortex: Task-related Brain Activity (Judged Math vs. Math Alone)

    The difference in fMRI BOLD signal intensity in the left dorsolateral prefrontal cortex (left dlPFC) between the social evaluative stress condition (judged math) and non-stress condition (math without judges). Mean group differences in signal intensity between the two math tasks were extracted from a brain region defined by the Harvard-Oxford brain atlas left middle frontal gyrus thresholded at 50% confidence.

    2 hours

  • Right Dorsolateral Prefrontal Cortex: Task-related Brain Activity (Judged Math vs. Math Alone)

    The difference in fMRI BOLD signal intensity in the right dorsolateral prefrontal cortex (right dlPFC) between the social evaluative stress condition (judged math) and non-stress condition (math without judges). Mean group differences in signal intensity between the two math tasks were extracted from a brain region defined by the Harvard-Oxford brain atlas right middle frontal gyrus thresholded at 50% confidence.

    2 hours

  • Amygdala-vmPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)

    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 difference in functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

    2 hours

  • Amygdala-left dlPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)

    For each participant, signal intensity (unitless measure) will be measured using fMRI in the amygdala over a five-minute recording period. Signal intensity will also be measured using fMRI in the left dorsolateral prefrontal cortex (dlPFC) 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 difference in functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

    2 hours

  • Amygdala-right dlPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)

    For each participant, signal intensity (unitless measure) will be measured using fMRI in the amygdala over a five-minute recording period. Signal intensity will also be measured using fMRI in the right dorsolateral prefrontal cortex (dlPFC) 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 difference in functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

    2 hours

  • Hypothalamus-vmPFC Connectivity: fMRI Functional Connectivity (Speech Prep vs. Rest)

    For each participant, signal intensity (unitless measure) will be measured using fMRI in the hypothalamus over a five-minute recording period. Signal intensity will also be measured using fMRI in the bilateral 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 difference in functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

    2 hours

  • Hypothalamus-left dlPFC Connectivity: fMRI Functional Connectivity (Speech vs. Rest)

    For each participant, signal intensity (unitless measure) will be measured using fMRI in the hypothalamus over a five-minute recording period. Signal intensity will also be measured using fMRI in the left dorsolateral prefrontal cortex (dlPFC) 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 difference in functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

    2 hours

  • Hypothalamus-right dlPFC Connectivity: fMRI Functional Connectivity (Speech vs. Rest)

    For each participant, signal intensity (unitless measure) will be measured using fMRI in the hypothalamus over a five-minute recording period. Signal intensity will also be measured using fMRI in the right dorsolateral prefrontal cortex (dlPFC) 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 difference in functional connectivity value (r, or correlation coefficient) for each buffering condition/group.

    2 hours

  • Change in Salivary Alpha Amylase, AUCi

    salivary Alpha Amylase is used to index autonomic/sympathetic function. 9 saliva samples are collected during the course of the assessment. These samples are collected at (1) arrival; T=0, (2) scan preparation; T=35 minutes, (3) entering scanner; T=55 minutes, (4) pre-TSST; T=75 minutes, (5) post-TSST; T=100 minutes, (6) pre-math alone; T=110 minutes, (7) post-math alone; T=120 minutes, (8) exiting scanner; T=130 minutes, (9) departure; T=140 minutes. 4 samples (3-6) are assayed for salivary alpha amylase in micrograms per milliliter (sAA). Area under the curve at intercept (AUCi) is calculated using samples 3-6 with sample 3 as the intercept.

    2 hours

Secondary Outcomes (12)

  • Self Report of Stress

    2 hours

  • Peer Acceptance/Rejection

    Parent report of child's general experience, collected over 30 minutes

  • Behavioral Inhibition

    Parent report of child's general experience, collected over 30 minutes

  • Internalizing Symptoms

    Parent report of child's general experience, collected over 30 minutes

  • Externalizing Symptoms

    Parent report of child's general experience, collected over 30 minutes

  • +7 more secondary outcomes

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, Experimenter, No Social Partner.

Other: QuestionnairesOther: MRI

Experimenter

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, Experimenter, No Social Partner.

Other: QuestionnairesOther: 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, Experimenter, No Social Partner.

Other: QuestionnairesOther: MRI

Interventions

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

ExperimenterNo Social PartnerPrimary Parent
MRIOTHER

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

ExperimenterNo Social PartnerPrimary Parent

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Bonny Donzella
Organization
University of Minnesota

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

November 7, 2019

First Posted

December 26, 2019

Study Start

October 18, 2019

Primary Completion

June 24, 2023

Study Completion

June 24, 2023

Last Updated

March 30, 2026

Results First Posted

March 27, 2025

Record last verified: 2026-03

Locations