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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06445712
Other study ID # 202312107
Secondary ID UL1TR002345
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date April 30, 2025

Study information

Verified date May 2024
Source Washington University School of Medicine
Contact Susan Perlman, PHD
Phone 3142738403
Email PERLMANSUSAN@wustl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to investigate the role of physical pain in the link between childhood adversity and later psychopathology. Children who are participating in a larger longitudinal study will be asked to submerge their hand in cold water and hold it in the cold water as long as possible. Participants will do this twice, once alone and once holding the hand of their parent, to examine the role of parental support in pain development. The study will examine self-report of pain and salivary cortisol response to pain. It is hypothesized that children who have been exposed to more adversity will experience increased pain response and increased psychopathology symptoms. It is expected that higher social support in the family will decrease this relationship.


Description:

This study will initiate a program of prospective research, linking early life adversity to both pain and psychopathology symptoms in the pre-adolescent period. This study will examine these links using an existing longitudinal sample of 6.5-9.5 year-old children experiencing familial stress. The project will examine the relationship between dysregulation and pain sensitivity from the behavioral perspective, but also through HPA axis dysregulation. Finally, the project will probe parental support as a moderator on the relationship between dysregulation and pain and psychopathology symptoms. The project will use a novel adaptation of the cold pressor test to examine experimental pain sensitivity as a function of parental support by including a condition in which the child holds the hand of their parent during the task. The project will also examine the neural basis of social support through parent-child brain synchronization. Support for the proposed model may indicate that interventions that increase parental support might decrease both pain and psychopathology.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 6 Years to 9 Years
Eligibility Inclusion Criteria: - Subjects who have been enrolled in our ongoing CARE study Exclusion Criteria: - Subjects who have not participated in the CARE study

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Parental Support Cold Pressor Task
Child will submerge their hand in cold water alone and holding the hand of a parent.

Locations

Country Name City State
United States Laboratory for Child Brain Development Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Tolerance Time hand is held in cold water 0-120 seconds
Primary Pain Sensitivity Self-reported score on the Visual Analogue Scale for Pain. Participants use a physical sliding scale to indicate how much pain they experienced [ higher numbers are equal to more pain; (no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)] 0-60 seconds after experiencing stimulus
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