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Affective Social Buffering

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Social Stress
Adolescent Behavior

Treatments

Other: MRI
Other: Questionnaires

Study type

Interventional

Funder types

Other

Identifiers

NCT04312945
STUDY00006378-2

Details and patient eligibility

About

The purpose of this experiment is to determine the mechanisms through which parental buffering of stress physiology during affective stimulus presentation diminishes with pubertal development and whether this diminution of effectiveness extends to social buffering by peers (best friends), in comparison to a lack of social partners.

Full description

On visit one, the participant will complete questionnaires, including ones on pubertal development, screening for MRI safety, and quality of relations with parents and friends.

Within 2 weeks the participant will return to the University where they will undergo the following protocol. Participants will be randomly assigned to one of 3 conditions that differ by who is with them in the scanner room: Primary Parent, Close Friend, No Social Partner. (N=50 per condition, 25 male, 25 female).

Once at the Center for Magnetic Resonance Research, participants and the individual who will be with the participant in the scanning room will undergo an MRI safety screening (the repeat of what was completed over the phone). Females will be shown to a changing room where the investigators will privately question them about any possibility of pregnancy. The participant will also have a chance to experience a simulated MRI in order to determine whether they will be comfortable in an actual MRI. Participants will be shown into the scanning control room and one more safety check will be performed before they enter the scanner room and the scanner. If they are in one of the social buffering conditions, the social buffering partner will also enter the scanning room and will sit to the side of the scanner.

The scanning bed will then be moved into the barrel of the MRI machine. The participant will be wearing head phones to protect his/her hearing and to receive instructions from the control room. The participant will then complete two emotionally evocative paradigms. The investigators will use a 3T Siemens Prisma scanner with a standard 32-channel phased array head coil.

Enrollment

202 patients

Sex

All

Ages

11 to 14 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • sufficient vision to complete assent and study procedures
  • sufficient hearing to complete assent and study procedures
  • sufficient language skills to provide verbal and written assent

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)
  • youth taking systemic glucocorticoids
  • youth taking beta-adrenergic medications
  • diagnoses of psychiatric illness, seizure disorder or other neurological disorders
  • contraindications for MRI (implanted medical device; presence of non-removal metal in or on the body, including piercings, orthodontic braces or certain permanent retainers)
  • known pregnancy
  • tattoos
  • history of significant claustrophobia

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

202 participants in 3 patient groups

Primary Parent
Experimental group
Description:
Participants will be randomly assigned to one of 3 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, No Social Partner. In this case, the primary parent was present in the MRI room during the assessment.
Treatment:
Other: Questionnaires
Other: MRI
Close Friend
Experimental group
Description:
Participants will be randomly assigned to one of 3 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend,No Social Partner. In this case, the close friend was present in the MRI room during the assessment.
Treatment:
Other: Questionnaires
Other: MRI
No Social Partner
Experimental group
Description:
Participants will be randomly assigned to one of 3 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, No Social Partner. In this case, no social partner was present in the MRI room during the assessment.
Treatment:
Other: Questionnaires
Other: MRI

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Bonny Donzella

Data sourced from clinicaltrials.gov

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