Does Social Buffering Continue to be Effective Over the Peripubertal Period When Friends Share the Stressor Experience?

February 2, 2025 updated by: University of Minnesota
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Adolescents experience social evaluation stress frequently. However, it is likely that often they are not alone, but with friends who are also going through the same experience. Thus, it is possible that under these conditions, social buffering by friends does not wane over the peripubertal period. Participants will be assigned to social conditions while engaging in an evaluative stressor task.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
269

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Friend and Target Both
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
random assignment to Friend and Target Both condition
Experimental: Experimental: Friend Provides Support
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
random assignment to Friend Provides Support condition
Experimental: Experimental: Unfamiliar Peer and Target
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
random assignment to Unfamiliar Peer and Target condition
Experimental: Experimental: Alone
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
random assignment to Alone condition

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cortisol AUCi
Time Frame: 2 hours
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
Time Frame: 2 hours
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self Report of Stress
Time Frame: 2 hours
Self-report of stress using a Likert-type scale with 5 levels of stress felt: (1) Not At All, (2) A Little, (3) Some, (4) A Lot, (5) A Whole Lot. Level of stress was reported for at these points during the assessment: (1) How stressed did you feel when you first connected on the video call and saw the experimenter?, (2) How stressful was the period of time before we started the video?, (3) How stressful did you feel while watching the video?, (4) How stressful was the period of time when you were preparing your speech and thinking about what to say?, (5) How stressful was giving the speech?, (6) How stressful was the math portion?, (7) How stressed do you feel now, after the speech and math portions are done? Self reported stress was computed as the mean of items (4, 5, 6) - item 1.
2 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hours Since Awakening. Potential Covariate
Time Frame: day of testing session

Participants report the number of hours between waking up on the day of assessment and the start of the TSST test.

This is only a potential covariate for cortisol, which follows a circadian rhythm.
day of testing session
Pretax Family Income. Potential Covariate
Time Frame: calendar year previous to TSST session
Parents report on gross family income on an 11-point ordinal scale: (1) Less than $15,000, (2) $15,001 to $25,000, (3) $25,001 to $35,000, (4) $35,001 to $50,000, (5) $50,001 to $75,000, (6) $75,001 to $100,000, (7) $100,001 to $125,000, (8) $125,001 to $150,000, (9) $150,001 to $175,000, (10) $175,001 to 200,000, (11) $200,001 or more
calendar year previous to TSST session
Parental Average Education Level. Potential Covariate
Time Frame: lifetime
Parents report education level for both parents on a 6-point ordinal scale: (1) Less than high school degree, (2) High school or GED, (3) Associate degree, college academia program, (4) Bachelor's degree, (5) Master's degree, (6) Professional and/or Doctorate degree. Average of parents' education is calculated and reported.
lifetime
Number of Adults in the Home. Potential Covariate
Time Frame: day of TSST session
Parents report on how many adults are living in the home.
day of TSST session
Caffeine or Nicotine Use. Potential Covariate
Time Frame: 1-2 hours prior to TSST session
Youth report on whether they consumed caffeine or nicotine in the 1-2 hours prior to the TSST assessment. Coded as no=0, yes=1. Used as a potential covariate for heart rate and neuroendocrine measures.
1-2 hours prior to TSST session
Granger Score. Potential Covariate
Time Frame: day of 2 hour TSST session
The Granger score (ordinal, modeled continuously) is a score based on work by Doug Granger of medications that can affect activity of the HPA axis, weighted by significance of potential impact (Granger, Hibel, Fortunato, & Kapelewski, 2009). Each medication taken is given a score of 0, 1, or 2, and all medication scores for a participant is summed, resulting in scores from 0 to infinity. Lower scores are less likely to influence cortisol. Potential Covariate
day of 2 hour TSST session
Quality of Relationship With Primary Parent, BSV Positive Attachment Scale. Potential Covariate
Time Frame: 2 hour TSST session
Network of Relationships Inventory (NRI) reported by youth for their primary parent on how much they experience various emotions or incidents (e.g. How much free time do you spend with this person?), reported on a 5-point scale: (1) Little or None, (2) Somewhat, (3) Very Much, (4) Extremely Much, (5) The Most. Mean scores calculated from all positive attachment items, range 1-5. Potential Covariate. This self report reflects the general current state of the relationship, without a specific timeframe, and was obtained during the TSST session.
2 hour TSST session
Quality of Relationship With Close Friend, BSV Positive Attachment Scale. Potential Covariate
Time Frame: 2 hour TSST session
Network of Relationships Inventory (NRI) reported by youth for their close friend on how much they experience various emotions or incidents (e.g. How much free time do you spend with this person?), reported on a 5-point scale: (1) Little or None, (2) Somewhat, (3) Very Much, (4) Extremely Much, (5) The Most. Mean scores calculated from all positive attachment items, ranging 1-5. Potential Covariate. This self report reflects the general current state of the relationship, without a specific timeframe, and was obtained during the TSST session.
2 hour TSST session
Peer Acceptance/Rejection. Potential Covariate
Time Frame: 2 hour TSST session
Scale on the MacArthur Health and Behavior Questionnaire, 5pt scale (1-5), high scores indicate peer acceptance. This report reflects the general current state of the youth, without a specific timeframe, and was obtained during the TSST session.
2 hour TSST session
Behavioral Inhibition. Potential Covariate
Time Frame: 2 hour TSST session
Scale on the MacArthur Health and Behavior Questionnaire, 3pt scale (0,1,2), high scores indicate inhibition. This report reflects the general current state of the youth, without a specific timeframe, and was obtained during the TSST session.
2 hour TSST session
Internalizing Symptoms. Potential Covariate
Time Frame: 2 hour TSST session
Higher order measure from the MacArthur Health and Behavior Questionnaire, 3pt scale (0,1,2), high scores indicate Internalizing. This report reflects the general current state of the youth, without a specific timeframe, and was obtained during the TSST session.
2 hour TSST session
Externalizing Symptoms. Potential Covariate
Time Frame: 2 hour TSST session
Higher order measure from the MacArthur Health and Behavior Questionnaire, 3pt scale (0,1,2), high scores indicate externalizing. This report reflects the general current state of the youth, without a specific timeframe, and was obtained during the TSST session.
2 hour TSST session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Megan Gunnar, PhD, University of Minnesota
  • Principal Investigator: Kathleen Thomas, PhD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00006378-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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