Using Parent Engagement to Improve the Wellbeing of Black Premature Infants With Chronic Lung Disease

NCT06474767 | Not Yet Recruiting DMC

• 1 other identifier: IRB00447949
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this pilot study is to test the feasibility and acceptability of a collaborative goal setting intervention to improve parent engagement of Black preterm infants with chronic lung disease in primary care. Preliminary impact on child and parent outcomes will also be explored. The main questions it aims to answer are: 1) Will parents complete a pre-visit questionnaire that asks about goals for the child? 2) Does use of the pre-visit questionnaire help parents to achieve self-identified goals? Participants will fill out a pre-visit questionnaire prior to the child's well visit. The participants will then complete two surveys after the visit (1 week and 2 months after).

Conditions

Chronic Lung Disease

Outcome Measures

Primary Outcomes (4)

• Feasibility as measured by number of interventions completed

  Number of participants who complete the pediatric collaborative goal setting intervention out of the number of consented participants who are sent a link prior to the child's well visit

  Day 0

• Feasibility as measured by the time it takes participant to complete intervention

  Amount of time (minutes) that participant has the pediatric collaborative goal setting intervention open

  Day 0

• Feasibility as measured by the number of goals submitted by each participant

  Number of goals submitted by each participant through the pediatric collaborative goal setting intervention

  Day 0

• Acceptability of the intervention as assessed by the Acceptability of Intervention Measure (AIM) scale

  Measured by the Acceptability of Intervention Measure (AIM) scale - a 4 item survey with 5 point Likert scales from Completely Disagree to Completely Agree. Score ranges from 4 to 20, where higher scores indicate greater acceptability.

  Day 7 post-intervention

Secondary Outcomes (4)

• Goal attainment as assessed by number of goals submitted

  Day 60 post-intervention

• Participation activation as measured by Parent Patient Activation Measure 10

  Day 60 post-intervention

• Participant's child's respiratory symptoms as measured by self-report

  Day 60 post-intervention

• Participant's child's use of the emergency department for breathing symptoms as measured by self-report

  Day 60 post-intervention

Study Arms (1)

Pediatric Collaborative Goal Setting Participant

EXPERIMENTAL

Participants will receive pediatric collaborative goal setting (P-CGS) intervention one to three days prior to the child's identified well visit and will be asked to complete it before or at the time of the visit. Participants will identify 1 goal for the child's health and the parent's own health, covering both medical and social domains. Participants will then be prompted to share the content with the child's provider when asked about the parent's priorities during the child's visit. One week and two months after the child's well visit where pediatric collaborative goal setting was used, participants will complete follow up surveys.

Behavioral: P-CGS (Pediatric Collaborative Goal Setting)

Interventions

P-CGS (Pediatric Collaborative Goal Setting) BEHAVIORAL

Electronic questionnaire sent to participants ahead of a pediatric primary care well child visit, assessing goals for themselves and the child's health with prompt to share with providers during visit

Pediatric Collaborative Goal Setting Participant

Eligibility Criteria

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

You may qualify if:

• Parent/legal guardian of child born prior to 37 weeks gestational age
• Parent/legal guardian of child with diagnosis of chronic lung disease or bronchopulmonary dysplasia, as defined by the child's clinical team at the time of hospital discharge
• Parent/legal guardian of child who identifies that child's race as Black
• English speaking

You may not qualify if:

• Parent/legal guardian of child enrolled in palliative care or hospice services at time of hospital discharge
• Parent/legal guardian of child older than 12 months chronological age

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Officials

• Brandon M Smith, MD MPH

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandon M Smith, MD MPH

CONTACT

443-997-5437; brandon.smith@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09