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

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ClinicalTrials.gov Identifier: NCT04311996
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : March 14, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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).

Condition or disease Intervention/treatment Phase
Adolescent Behavior Social Stress Other: Questionnaires Other: TSST Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Does Social Buffering Continue to be Effective Over the Peripubertal Period When Friends Share the Stressor Experience?
Actual Study Start Date : October 25, 2021
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Arm Intervention/treatment
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: Questionnaires
The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.

Other: TSST
Participants will, via an online session, complete the TSST which is a standardized speech & math performance known to elicit a cortisol stress response.
Other Name: Trier Social Stress Test

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

Other: TSST
Participants will, via an online session, complete the TSST which is a standardized speech & math performance known to elicit a cortisol stress response.
Other Name: Trier Social Stress Test

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

Other: TSST
Participants will, via an online session, complete the TSST which is a standardized speech & math performance known to elicit a cortisol stress response.
Other Name: Trier Social Stress Test

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

Other: TSST
Participants will, via an online session, complete the TSST which is a standardized speech & math performance known to elicit a cortisol stress response.
Other Name: Trier Social Stress Test




Primary Outcome Measures :
  1. Change in Cortisol AUCi [ Time Frame: 2 hours ]
    8 samples will be taken during the course of the assessment. Area under the curve from initial (baseline) will be calculated and used in the analyses.

  2. Change in salivary Alpha Amylase, AUCi [ Time Frame: 2 hours ]
    salivary Alpha Amylase is used to index autonomic/sympathetic function. From 3 of the saliva samples already taken during the course of the assessment, alpha amylase will be determined by assay. Area under the curve will be calculated during periods of stress (social evaluation) and non-stress (no evaluation) during the course of the assessment. Outcome is reported as the difference between condition scores.


Secondary Outcome Measures :
  1. Self Report of Stress [ Time Frame: 2 hours ]
    The Self Report of Stress is an 8-item questionnaire assessing participant level of stress at various time points across the session. Items are rated on a 5 point Likert scale. Total score is the unweighted mean of item scores. Total scores range from 0 to 40, with higher scores indicating greater stress. The assessment will be administered at baseline (no stress) and during a period of stress. The outcome will be reported as the difference between the baseline period and experimental stress period.



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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04311996


Contacts
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Contact: Bonny Donzella 6126244351 donzella@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Bonny Donzella    612-624-4351    donzella@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Megan Gunnar, PhD University of Minnesota
Principal Investigator: Kathleen Thomas, PhD University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04311996    
Other Study ID Numbers: STUDY00006378-3
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: March 14, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No