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

NCT06164028 | Recruiting

• 1 other identifier: Pro00112874
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (2)

• Number of participants who understand features of the clinical outcome assessments

  Understanding (or clarity) of all features of the clinical outcome assessments (ObsRO measure or ClinRO measures) including, but not limited to, its instructions, questions, and response options.

  Approximately 1 hour

• Number of participants who find the indicators included in the clinical outcome assessments complete and relevant

  Completeness and relevance of indicators included in the clinical outcome assessments (ObsRO measure or ClinRO measures) for capturing observable behaviors in young children when she/he is reacting to painful experiences.

  Approximately 1 hour

Study Arms (2)

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.

Other: cognitive interview

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.

Other: cognitive interview

Interventions

cognitive interview OTHER

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

Caregiver; Clinician

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caregivers who cares for a child who is between 0 and 2 years and experiencing or has experienced acute pain. Clinicians who treats or works with pediatric patients who are between 0 and 2 years and being treated for acute pain.

You may qualify if:

• Caregivers
• Cares for a child who is both: Between 0 and \<2 years of age and experiencing or has experienced acute pain in the past four weeks in one of the following categories: Malignant or non-malignant visceral or hematologic disease; Surgery (or other procedure); Trauma or injury ; Congenital conditions
• Is over the age of 18 years
• Can speak and understand English or Spanish
• Is capable of and willing to provide informed consent for interview participation and to collect data from the child's medical record.
• Clinicians
• Practicing clinician in a clinical care environment
• Treats or works with pediatric patients who are between 0 and \<2 years of age AND being treated for acute pain.
• Cares for pediatric patients \>50% of their clinical time.
• Holds one of the following titles/positions: physician, clinical pharmacist (Pharm D), nurse practitioner, physician's assistant, nurse (with a BSN/RN or higher)
• Is over the age of 18 years
• Can speak and understand English
• Is capable of and willing to provide informed consent for interview participation.

You may not qualify if:

• Lack of access to a telephone or computer for interview
• For caregivers, has a child with acute pain who is premature at less than 32 weeks corrected gestational age at the time of enrollment and no other eligible child.

Sponsors & Collaborators

• Duke University: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 27701, United States

RECRUITING

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kanecia Zimmerman, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Wang, MBBS, MHS

CONTACT

919-668-5971; sophie.wang@duke.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 11, 2023
• Study Start: August 15, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)