Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002345 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain Assessment | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parental Support Cold Pressor Task | Behavioral | Child will submerge their hand in cold water alone and holding the hand of a parent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Tolerance | Time hand is held in cold water | 0-120 seconds |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory for Child Brain Development | St Louis | Missouri | 63108 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). Parental Support Cold Pressor Task: Child will submerge their hand in cold water alone and holding the hand of a parent. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). Parental Support Cold Pressor Task: Child will submerge their hand in cold water alone and holding the hand of a parent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Tolerance | Time hand is held in cold water | Posted | Mean | Standard Deviation | seconds | 0-120 seconds |
|
|
From start of data collection on participation day to subject leaving the laboratory (approximately 1.5 to 2 hours)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). Parental Support Cold Pressor Task: Child will submerge their hand in cold water alone and holding the hand of a parent. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Perlman | Washington University in St. Louis | 3142861700 | PERLMANSUSAN@wustl.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2025 | Dec 17, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| 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)] | Posted | Mean | Standard Deviation | units on a scale | 0-60 seconds after experiencing stimulus |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
Not provided
Not provided
Not provided