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A Qualitative Cognitive Interview Study to Evaluate Comprehensibility and Content Validity of a Caregiver Observer-reported Assessment and a Clinician-reported Assessment of Acute Pain in Infants and Young Children Who Are 0 to <2 Years of Age.
Led by Duke University · Updated on 2025-09-09
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
F
Food and Drug Administration (FDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the clarity and content validity of caregiver and clinician assessments designed to measure acute pain in infants and young children aged from birth to under 2 years. The study focuses on developing reliable Clinical Outcome Assessments (COAs) and endpoints that can be used in clinical trials for pain treatments targeted at this young population. This qualitative phase is part of a broader effort to improve pain assessment tools specifically for infants and toddlers. Participants will engage in approximately 60-minute semi-structured cognitive interviews conducted by trained interviewers via phone or Zoom. Caregivers will describe their child's pain experiences and provide feedback on the observer-reported outcome (ObsRO) measures. Clinicians will review video examples of infants and young children in pain and provide ratings using clinician-reported outcome (ClinRO) measures, followed by detailed evaluations of the assessment tools' components. This approach aims to improve both sets of assessments by probing their instructions, questions, and response options. During the study, caregivers and clinicians will share their perspectives through in-depth interviews, providing qualitative data to help refine the pain assessment tools. Researchers will analyze how well participants understand the assessments and whether the tools include all relevant pain indicators. The study involves minimal risk but includes measures to protect confidentiality. Participation includes consenting to interviews and, for caregivers, possibly sharing medical record information. The study is expected to continue until August 2026.
CONDITIONS
Brief Title
COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Caregivers must care for a child aged 0 to under 2 years who has experienced acute pain in the past four weeks from specific conditions such as disease, surgery, injury, or congenital issues
- Caregivers must be over 18 years old
- Caregivers must speak and understand English or Spanish
- Caregivers must be willing and able to provide informed consent and allow access to the child's medical records
- Clinicians must practice in a clinical care environment
- Clinicians must work with pediatric patients aged 0 to under 2 years treated for acute pain
- Clinicians must spend more than 50% of their clinical time caring for pediatric patients
- Clinicians must hold a relevant clinical title such as physician, clinical pharmacist, nurse practitioner, physician's assistant, or nurse with BSN/RN or higher
- Clinicians must be over 18 years old
- Clinicians must speak and understand English
- Clinicians must be willing and able to provide informed consent
You will not qualify if you...
- Lack of access to a telephone or computer for interview participation
- For caregivers, having a child with acute pain who was premature at less than 32 weeks corrected gestational age at enrollment and no other eligible child
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (phone or zoom)
Duration - Approximately 1 hour
Participants complete a semi-structured qualitative cognitive interview to assess their understanding and provide feedback on clinical outcome assessments of acute pain in infants and young children aged 0 to under 2 years.
1 interview visit (phone or zoom)
Trial Site Locations
Total: 1 location
1
Duke Clinical Research Institute
Durham, North Carolina, United States, 27701
Actively Recruiting
Research Team
S
Sophie Wang, MBBS, MHS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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