Child DevelopmentNCT06445712
Examining the Role of Pain in the Link Between Early Childhood Adversity and Psychopathology
A study testing Parental Support Cold Pressor Task in people with Child Development, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Child Development
- What is being tested?
- Parental Support Cold Pressor Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 23 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects who have been enrolled in our ongoing CARE study
Who cannot join
- Subjects who have not participated in the CARE study
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory for Child Brain Development
St Louis, Missouri, 63108
About this study
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.
Read the 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.
- Conditions
- Child Development
- Being tested
- Parental Support Cold Pressor Task
- Keywords
- Pain, Early Life Adversity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental Support Cold Pressor TaskBehavioural
Child will submerge their hand in cold water alone and holding the hand of a parent.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Parental Support Cold Pressor Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Tolerance
Time hand is held in cold water
Measured: 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)]
Measured: 0-60 seconds after experiencing stimulus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 May 2024
- Primary completion23 Mar 2025
- Study completion23 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445712
- Sponsor's protocol ID
- 202312107
- Other IDs
- UL1TR002345
- Status last verified
- Jan 2026
- First submitted
- 22 May 2024
- Last updated
- 27 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Role of Pain in the Link Between Early Childhood Adversity and Psychopathology
- ClinicalTrials.gov ID
- NCT06445712
- Acronym / sponsor ID
- 202312107
- Conditions
- Child Development
- Keywords
- Pain, Early Life Adversity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 23 Mar 2025 (actual)
- Study completion
- 23 Mar 2025 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Posted 27 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain Assessment | Experimental | Behavioral: Parental Support Cold Pressor TaskChildren 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). |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Subjects who have been enrolled in our ongoing CARE study
Key exclusion criteria (1 listed)
- Subjects who have not participated in the CARE study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parental Support Cold Pressor TaskChild will submerge their hand in cold water alone and holding the hand of a parent. | Behavioural | Pain Assessment |
Primary outcome
Pain Tolerance
Time frame: 0-120 seconds
Time hand is held in cold water
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)]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental Support Cold Pressor Task in people with Child Development, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Tolerance (time frame: 0-120 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.