Using Parent Engagement to Improve the Wellbeing of Black Premature Infants With Lung Disease
NCT Number: NCT06474767
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Lung Disease
Interventions: BEHAVIORAL: P-CGS (Pediatric Collaborative Goal Setting)
Sponsor: Johns Hopkins University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2026-07-01
Completion Date: 2027-06-30

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).

Primary Outcome Measures: 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: 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