- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06445712
Examining the Role of Pain in the Link Between Early Childhood Adversity and Psychopathology
January 26, 2026 updated by: Washington University School of Medicine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
St Louis, Missouri, United States, 63108
- Laboratory for Child Brain Development
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Subjects who have been enrolled in our ongoing CARE study
Exclusion Criteria:
- Subjects who have not participated in the CARE study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pain Assessment
Children will submerge their hand in cold water and be asked to hold it in as long as possible.
They will do this both alone and holding the hand of a parent (counterbalanced).
|
Child will submerge their hand in cold water alone and holding the hand of a parent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Tolerance
Time Frame: 0-120 seconds
|
Time hand is held in cold water
|
0-120 seconds
|
|
Pain Sensitivity
Time Frame: 0-60 seconds after experiencing stimulus
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2024
Primary Completion (Actual)
March 23, 2025
Study Completion (Actual)
March 23, 2025
Study Registration Dates
First Submitted
May 22, 2024
First Submitted That Met QC Criteria
May 31, 2024
First Posted (Actual)
June 6, 2024
Study Record Updates
Last Update Posted (Actual)
January 27, 2026
Last Update Submitted That Met QC Criteria
January 26, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202312107
- UL1TR002345 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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