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NCT Number: NCT06474767

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

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).

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Key information

Conditions

Chronic Lung Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Feasibility as measured by number of interventions completed

    Time frame: Day 0

    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

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

    Time frame: Day 0

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

  3. Feasibility as measured by the number of goals submitted by each participant

    Time frame: Day 0

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

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

    Time frame: Day 7 post-intervention

    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.

Secondary outcomes

  1. Goal attainment as assessed by number of goals submitted

    Time frame: Day 60 post-intervention

    Number of goals submitted as part of pediatric collaborative goal setting that were accomplished by participant since intervention

  2. Participation activation as measured by Parent Patient Activation Measure 10

    Time frame: Day 60 post-intervention

    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.

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

    Time frame: Day 60 post-intervention

    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.

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

    Time frame: Day 60 post-intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brandon M Smith, MD MPH

CONTACT

[email protected]

443-997-5437

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2024
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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