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Social Support for Stress in Children and Adolescents
N/A
Recruiting
Led By Megan Gunnar, PhD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Must not have
History of serious medical illness (e.g., cancer, organ transplant)
Youth taking beta-adrenergic medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at how well parents can help relieve stress in children of different ages, and whether friends have the same effect.
Who is the study for?
This trial is for adolescents with normal hearing, vision, and language skills. It's not for those with autism, tattoos that interfere with MRI scans, severe claustrophobia, certain medications like beta-blockers or glucocorticoids, psychiatric or neurological disorders, serious medical conditions like cancer or organ transplants, pregnancy, congenital/chromosomal disorders (e.g., Down Syndrome), or metal implants/piercings/braces.
What is being tested?
The study aims to understand how parental support helps reduce stress in teenagers during scary situations and if this changes as they grow up. It also looks at whether friends or strangers can provide similar comfort. Participants will answer questionnaires and undergo MRI scans.
What are the potential side effects?
There are no direct side effects from the interventions since they involve non-invasive procedures such as filling out questionnaires and undergoing MRI scans. However, individuals prone to anxiety may experience discomfort during the aversive conditioning.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of a serious illness like cancer or an organ transplant.
Select...
I am a young person taking beta-blocker medications.
Select...
I have a condition like Down Syndrome or cerebral palsy.
Select...
I am a young person currently taking glucocorticoids.
Select...
I have been diagnosed with a psychiatric or neurological disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Amygdala-dmPFC by Task: Psychophysiological interaction (PPI) functional connectivity during threat conditioning
Amygdala-vmPFC by Task: Psychophysiological interaction (PPI) functional connectivity during threat conditioning
Change Heart Rate Response
+9 moreSecondary study objectives
Change in Self Report of Stress
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Primary ParentExperimental Treatment2 Interventions
Participants will be randomly assigned to one of 4 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, Experimenter, No Social Partner.
Group II: No Social PartnerExperimental Treatment2 Interventions
Participants will be randomly assigned to one of 4 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, Experimenter, No Social Partner.
Group III: ExperimenterExperimental Treatment2 Interventions
Participants will be randomly assigned to one of 4 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, Experimenter, No Social Partner.
Group IV: Close FriendExperimental Treatment2 Interventions
Participants will be randomly assigned to one of 4 conditions that differ by who is with them in the MRI scanner room: Primary Parent, Close Friend, Experimenter, No Social Partner.
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,434 Previous Clinical Trials
1,621,443 Total Patients Enrolled
Megan Gunnar, PhDPrincipal InvestigatorUniversity of Minnesota
3 Previous Clinical Trials
568 Total Patients Enrolled
Kathleen Thomas, PhDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
400 Total Patients Enrolled
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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