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Completed

NCT Number: NCT06445712

Examining the Role of Pain in the Link Between Early Childhood Adversity and Psychopathology

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.

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Key information

Conditions

Child Development Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory for Child Brain Development

St Louis, Missouri, 63108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who have been enrolled in our ongoing CARE study

Exclusion criteria

  • Subjects who have not participated in the CARE study

Treatment and study plan

Parental Support Cold Pressor Task

Behavioral

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

Primary outcomes

  1. Pain Tolerance

    Time frame: 0-120 seconds

    Time hand is held in cold water

  2. 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)]

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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