- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04311996
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
269
Phase
- 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 Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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).
|
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).
|
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).
|
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).
|
random assignment to Alone condition
|
What is the study measuring?
Primary Outcome Measures
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
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
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
Investigators
- 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)
October 25, 2021
Primary Completion (Actual)
June 24, 2023
Study Completion (Actual)
June 24, 2023
Study Registration Dates
First Submitted
March 13, 2020
First Submitted That Met QC Criteria
March 13, 2020
First Posted (Actual)
March 17, 2020
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 2, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID 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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