COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06164028
Status
Recruiting
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Conditions

  • Acute Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • cognitive interview — OTHER
    Participants will take part in a semi-structured qualitative interview (\~1 hour).

Study Details

Evaluate the content validity and comprehensibility of a caregiver observer-reported outcome assessment and clinician-reported assessments for acute pain in children aged 0 to \<2 years. The primary objective of the Qualitative Protocol in the UH3 phase study is to establish or create reliable Clinical Outcome Assessments (COAs) and endpoints that can assess acute pain during clinical trials of pain therapeutics specifically designed for infants and young children (0 - \<2 years).

Key Dates

Start date
Aug 15, 2023
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Caregiver
    Participants will take part in a semi-structured qualitative interview (\~1 hour). The first set of questions will provide an opportunity for the caregiver to describe the type of conditions or injuries their child has experienced and how their child reacted to the potentially painful experiences. Subsequently, the cognitive interview scripts will be structured to evaluate different components of the questionnaire (ObsRO measure), including the instructions, the question stems, the response options, and other key aspects of the COA.Once the participant has completed the questionnaire, the interviewer will probe on additional issues related to informing the assessment of content validity.
  • Arm: Clinician
    Participants will take part in a semi-structured qualitative interview (\~1 hour). The first set of questions will provide an opportunity for the clinicians to describe observable indicators that a young child is in pain. 4 YouTube video links based on age groups (birth to 1 month,1 month to 6 months, 6 months to 12 months, and12 months to 24 months), will be reviewed by participants. Clinicians will be asked to rate the child's pain using the ClinRO measures while being probed for question content and understanding. Subsequently, the cognitive interview scripts will be structured to evaluate different components of the ClinRO measures, including the instructions, the question stems, the response options, and other key aspects of the COA. Once the participant has completed the questionnaire, the interviewer will probe on additional issues related to informing the assessment of content validity.

Primary Outcome Measure

Number of participants who understand features of the clinical outcome assessments [ Time Frame: Approximately 1 hour ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Clinical Research InstituteDurhamNorth Carolina27701
Sophie Wang, MBBS, MHS
[email protected]
919-668-5971

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