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

Addressing Health Disparities in Chronic Lung Disease for Preterm Infants Through Parent Engagement

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Lung Disease
• Intervention / Treatment: Behavioral: P-CGS (Pediatric Collaborative Goal Setting)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brandon M Smith, MD MPH; Phone Number: 443-997-5437; Email: brandon.smith@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pediatric Collaborative Goal Setting Participant; 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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goal attainment as assessed by number of goals submitted	Number of goals submitted as part of pediatric collaborative goal setting that were accomplished by participant since intervention	Day 60 post-intervention
Participation activation as measured by Parent Patient Activation Measure 10	Measured by the Parent Patient Activation Measure scale - a 7 item survey with 4 point Likert scales (total score range 7-28) from Disagree Strongly to Agree Strongly with higher scores indicating a better outcome.	Day 60 post-intervention
Participant's child's respiratory symptoms as measured by self-report	Frequency of rescue inhaler use and symptoms of wheezing, rated on 5 point Likert scale (total score range 1-5) from Never to Every day with higher scores indicating more use and worse outcome. This is a survey instrument constructed by the study team.	Day 60 post-intervention
Participant's child's use of the emergency department for breathing symptoms as measured by self-report	Frequency of emergency department visits, rated on 5 point Likert scale (total score range 1-5) from Never to Every day with higher scores indicating more use and worse outcome. This is a survey instrument constructed by the study team.	Day 60 post-intervention

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Brandon M Smith, MD MPH, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: IRB00447949

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No