Chronic Lung DiseaseNCT06474767
Using Parent Engagement to Improve the Wellbeing of Black Premature Infants With Chronic Lung Disease
A study testing P-CGS (Pediatric Collaborative Goal Setting) in people with Chronic Lung Disease, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Lung Disease
- What is being tested?
- P-CGS (Pediatric Collaborative Goal Setting)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
- Conditions
- Chronic Lung Disease
- Being tested
- P-CGS (Pediatric Collaborative Goal Setting)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-CGS (Pediatric Collaborative Goal Setting)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: P-CGS (Pediatric Collaborative Goal Setting) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 7 post-intervention
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 60 post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Dec 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brandon M Smith, MD MPH, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474767
- Sponsor's protocol ID
- IRB00447949
- Status last verified
- Jul 2026
- First submitted
- 20 Jun 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Health Disparities in Chronic Lung Disease for Preterm Infants Through Parent Engagement
- ClinicalTrials.gov ID
- NCT06474767
- Acronym / sponsor ID
- IRB00447949
- Conditions
- Chronic Lung Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Collaborative Goal Setting Participant | Experimental | Behavioral: P-CGS (Pediatric Collaborative Goal Setting)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Pediatric Collaborative Goal Setting Participant |
Primary outcome
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
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
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
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.
4 secondary outcomes
Goal attainment as assessed by number of goals submitted
Time frame: Day 60 post-intervention
Participation activation as measured by Parent Patient Activation Measure 10
Time frame: Day 60 post-intervention
Participant's child's respiratory symptoms as measured by self-report
Time frame: Day 60 post-intervention
Participant's child's use of the emergency department for breathing symptoms as measured by self-report
Time frame: Day 60 post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brandon M Smith, MD MPH principal investigator
Johns Hopkins School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing P-CGS (Pediatric Collaborative Goal Setting) in people with Chronic Lung Disease, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandon M Smith, MD MPH (443-997-5437, brandon.smith@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by number of interventions completed (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.