NCT06445712

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2025

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 27, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

May 22, 2024

Results QC Date

December 17, 2025

Last Update Submit

January 26, 2026

Conditions

Keywords

PainEarly Life Adversity

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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).

Behavioral: Parental Support Cold Pressor Task

Interventions

Child will submerge their hand in cold water alone and holding the hand of a parent.

Pain Assessment

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subjects who have been enrolled in our ongoing CARE study

You may not qualify if:

  • Subjects who have not participated in the CARE study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory for Child Brain Development

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Susan Perlman
Organization
Washington University in St. Louis

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2024

First Posted

June 6, 2024

Study Start

May 1, 2024

Primary Completion

March 23, 2025

Study Completion

March 23, 2025

Last Updated

January 27, 2026

Results First Posted

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations