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

NCT ID: NCT06164028

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2026-08-31

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).

Detailed Description

The study aims to assess understandability (clarity) and content validity of the newly designed clinician-reported outcome (ClinRO) and the existing clinician-reported outcome (ClinRO) measures of acute pain in infants and young children who are 0 to <2 years of age.

This qualitative research employs 60-minute cognitive interviews conducted through phone or zoom by a trained interviewer. The study involves caregivers with children aged 0 to <2 years old who are experiencing or have experienced acute pain, and clinicians who dedicate at least half of their clinical time caring for pediatric patients within the same age range.

The data analysis will be of a qualitative nature and rely on in-depth interviews conducted with relatively limited sample sizes.

The study entails utilizing standard interview techniques and poses a negligible amount of risk. However, there is the potential risk of loss of confidentiality.

Conditions

Acute Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

cognitive interview

Intervention Type: OTHER

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

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.

cognitive interview

Intervention Type: OTHER

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

Interventions

cognitive interview

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kanecia Zimmerman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Clinical Research Institute

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sophie Wang, MBBS, MHS

Role: CONTACT

sophie.wang@duke.edu

919-668-5971

Facility Contacts

Sophie Wang, MBBS, MHS

Role: primary

sophie.wang@duke.edu

919-668-5971

Other Identifiers

Pro00112874

Identifier Type: -

Identifier Source: org_study_id