Adolescent BehaviorNCT04311996

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

A study testing Friend and target, Friend support and unfamiliar peer and target in people with Adolescent Behavior and Social Stress, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 11 to 14 yearsHealthy volunteers can take part
Conditions the study is for: Adolescent Behavior, Social Stress
What is being tested?: Friend and target, Friend support and unfamiliar peer and target
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 269 participants
Where: 1 siteUnited States
Study dates: 25 Oct 2021to 24 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 11 to 14 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Minnesota
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

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).

Read the 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.

Conditions: Adolescent Behavior, Social Stress
Being tested: Friend and target, Friend support, unfamiliar peer and target, alone
Medical subject headings: Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Friend and targetOther
random assignment to Friend and Target Both condition
Friend supportOther
random assignment to Friend Provides Support condition
unfamiliar peer and targetOther
random assignment to Unfamiliar Peer and Target condition
aloneOther
random assignment to Alone condition

Study groups in NCT04311996
Study group	Role	What they receive
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). Receives: 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). Receives: 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). Receives: 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). Receives: Other: alone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 2 hours

Secondary outcomes (1)

Self Report of Stress
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.
Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Oct 202124 Jun 2023

First posted17 Mar 2020
Study start25 Oct 2021
Primary completion24 Jun 2023
Study completion24 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 269 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04311996
Sponsor's protocol ID: STUDY00006378-3
Status last verified: Feb 2025
First submitted: 13 Mar 2020
Last updated: 24 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Adolescent Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Social Buffering Continue to be Effective Over the Peripubertal Period When Friends Share the Stressor Experience?
ClinicalTrials.gov ID: NCT04311996
Acronym / sponsor ID: STUDY00006378-3
Conditions: Adolescent Behavior, Social Stress
Study type: Interventional
Recruitment status: Completed
Enrolment: 269 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: 25 Oct 2021 (actual)
Primary completion: 24 Jun 2023 (actual)
Study completion: 24 Jun 2023 (actual)
First posted: 17 Mar 2020 (actual)
Results: Posted 24 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Experimental: Friend and Target Both	Experimental	Other: Friend and targetThere 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).
Experimental: Friend Provides Support	Experimental	Other: Friend supportThere 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).
Experimental: Unfamiliar Peer and Target	Experimental	Other: unfamiliar peer and targetThere 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).
Experimental: Alone	Experimental	Other: aloneThere 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).

Who may qualify

Ages: 11 to 14 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Friend and targetrandom assignment to Friend and Target Both condition	Other	Experimental: Friend and Target Both
Friend supportrandom assignment to Friend Provides Support condition	Other	Experimental: Friend Provides Support
unfamiliar peer and targetrandom assignment to Unfamiliar Peer and Target condition	Other	Experimental: Unfamiliar Peer and Target
alonerandom assignment to Alone condition	Other	Experimental: Alone

Primary outcome

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.
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.

1 secondary outcome

Self Report of Stress
Time frame: 2 hours

Results and safety

Results posted to the registry on 24 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: Friend and Target Both	63	61
Experimental: Friend Provides Support	72	65
Experimental: Unfamiliar Peer and Target	65	62
Experimental: Alone	69	68

Primary outcome: Cortisol AUCi

Time frame: 2 hours. Mean (Standard Deviation). Unit: (ug/dl)*minutes

Measure	Experimental: Friend and Target Both n = 61	Experimental: Friend Provides Support n = 63	Experimental: Unfamiliar Peer and Target n = 61	Experimental: Alone n = 66
Value	0.0043 (0.06)	0.0256 (0.06)	0.0177 (0.05)	0.022 (0.06)

Population analysed: 256 participants were completed, with 61 Friend and Target Both, 65 Friend Support, 62 Unfamiliar Peer, and 68 Alone. For each outcomes, all available analyzable data were included in results, sometimes resulting in lower n.

Primary outcome: sAA AUCi

Time frame: 2 hours. Mean (Standard Deviation). Unit: (ug/mL)*minute

Measure	Experimental: Friend and Target Both n = 53	Experimental: Friend Provides Support n = 56	Experimental: Unfamiliar Peer and Target n = 55	Experimental: Alone n = 65
Value	0.0364 (0.12)	0.0434 (0.09)	0.0021 (0.14)	0.0255 (0.08)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Friend and Target Both	0 of 63 (0%)	0 of 63 (0%)	0 of 63
Friend Provides Support	0 of 72 (0%)	0 of 72 (0%)	0 of 72
Unfamiliar Peer	0 of 65 (0%)	0 of 65 (0%)	0 of 65
Alone	0 of 69 (0%)	0 of 69 (0%)	0 of 69

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Megan Gunnar, PhD principal investigator

University of Minnesota

Kathleen Thomas, PhD principal investigator

University of Minnesota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Friend and target, Friend support and unfamiliar peer and target in people with Adolescent Behavior and Social Stress, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cortisol AUCi (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04311996.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.