NCT04311996

Brief Summary

The purpose of this experiment is to determine whether social buffering by friends of stress physiology remains effective later in puberty when friends share the load versus when they provide support but are not undergoing the stressor with the target child. There are four conditions: (1) Friend and Target both undergo the stressor, (2) Friend provides support but does not undergo the stressor, (3) Unfamiliar Peer and Target undergo the stressor, and (4) Alone (no partner).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
269

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

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

First Submitted

Initial submission to the registry

March 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 25, 2021

Completed
1.7 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
1.7 years until next milestone

Results Posted

Study results publicly available

February 24, 2025

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

March 13, 2020

Results QC Date

May 28, 2024

Last Update Submit

February 2, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cortisol AUCi

    Cortisol response to the TSST, measured as Area Under the Curve, increase from baseline. 7 Samples were taken during the course of the assessment, at (1) arrival for training purposes; (2) after the calming video, 30 minutes after arrival; (3) after 5 minutes of speech preparation; (4) after 10+minutes of speech and math performance; (5) 15 minutes after sample 4; (6) 10 minutes after sample 5; (7) 10 minutes after sample 6. Area under the curve at intercept (AUCi) is calculated using samples 2-7 with sample 2 as the intercept.

    2 hours

  • sAA AUCi

    Salivary Alpha Amylase response to the TSST, measured as Area Under the Curve, increase from baseline. 7 Samples were taken during the course of the assessment, at (1) arrival for training purposes; (2) after the calming video, 30 minutes after arrival; (3) after 5 minutes of speech preparation; (4) after 10+minutes of speech and math performance; (5) 15 minutes after sample 4; (6) 10 minutes after sample 5; (7) 10 minutes after sample 6. Of those, samples (2, 4, 5) are assayed for salivary alpha amylase (sAA) in micrograms per milliliter. Area under the curve at intercept (AUCi) is calculated using samples 2, 4, 5 with sample 2 as the intercept.

    2 hours

Secondary Outcomes (1)

  • Self Report of Stress

    2 hours

Other Outcomes (12)

  • Hours Since Awakening. Potential Covariate

    day of testing session

  • Pretax Family Income. Potential Covariate

    calendar year previous to TSST session

  • Parental Average Education Level. Potential Covariate

    lifetime

  • +9 more other outcomes

Study Arms (4)

Experimental: Friend and Target Both

EXPERIMENTAL

There are four conditions: (1) Friend and Target both undergo the stressor, (2) Friend provides support but does not undergo the stressor, (3) Unfamiliar Peer and Target undergo the stressor, and (4) Alone (no partner).

Other: Friend and target

Experimental: Friend Provides Support

EXPERIMENTAL

There are four conditions: (1) Friend and Target both undergo the stressor, (2) Friend provides support but does not undergo the stressor, (3) Unfamiliar Peer and Target undergo the stressor, and (4) Alone (no partner).

Other: Friend support

Experimental: Unfamiliar Peer and Target

EXPERIMENTAL

There are four conditions: (1) Friend and Target both undergo the stressor, (2) Friend provides support but does not undergo the stressor, (3) Unfamiliar Peer and Target undergo the stressor, and (4) Alone (no partner).

Other: unfamiliar peer and target

Experimental: Alone

EXPERIMENTAL

There are four conditions: (1) Friend and Target both undergo the stressor, (2) Friend provides support but does not undergo the stressor, (3) Unfamiliar Peer and Target undergo the stressor, and (4) Alone (no partner).

Other: alone

Interventions

random assignment to Friend and Target Both condition

Experimental: Friend and Target Both

random assignment to Friend Provides Support condition

Experimental: Friend Provides Support

random assignment to Unfamiliar Peer and Target condition

Experimental: Unfamiliar Peer and Target
aloneOTHER

random assignment to Alone condition

Experimental: Alone

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • sufficient vision, hearing, and language skills to provide verbal and written assent
  • ability to see and read stimuli presented on the computer screen
  • ability to hear verbal instructions provided by the experimenter and judges

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)
  • serious psychiatric illness
  • systemic glucocorticoids or beta-adrenergic medication use

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

Single Person

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Limitations and Caveats

Note that while parents consented and completed questionnaires about their family or child, they are never the focus of analysis or considered enrolled in the study. They are consenting to their child's enrollment and reporting on their child's environment, health, and behavior.

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

March 13, 2020

First Posted

March 17, 2020

Study Start

October 25, 2021

Primary Completion

June 24, 2023

Study Completion

June 24, 2023

Last Updated

February 24, 2025

Results First Posted

February 24, 2025

Record last verified: 2025-02

Locations