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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04311996
Other study ID # STUDY00006378-3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 25, 2021
Est. completion date October 2024

Study information

Verified date March 2024
Source University of Minnesota
Contact Bonny Donzella
Phone 6126244351
Email donzella@umn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaires
The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.
TSST
Participants will, via an online session, complete the TSST which is a standardized speech & math performance known to elicit a cortisol stress response.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Cortisol AUCi 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 hours
Primary Change in salivary Alpha Amylase, AUCi 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. 2 hours
Secondary Self Report of Stress 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. 2 hours
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