Immigrant Caregiver Health Care Navigation for ChildrenNCT03719976
Prepared Parents Helping Kids
A study testing Group-based educational intervention in people with Immigrant Caregiver Health Care Navigation for Children, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Learning to navigate the US health system is challenging for many new immigrants. This pilot study will determine whether an intervention to teach parents key skills needed to access health care for children is feasible and acceptable to immigrant parents. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immigrant Caregiver Health Care Navigation for Children
- What is being tested?
- Group-based educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2018to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult age 18 years or older
- Parent of a child <18 years
- Nepali-speaking
- Resident of the US for <10 years
Who cannot join
- Scheduled to move away from the study location (e.g., to another city) before the end of the 6-session intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Bhutanese American Organization - Philadelphia
Philadelphia, Pennsylvania, 19148
About this study
Official title: Prepared Parents Helping Kids: Teaching Health Care Navigation for Bhutanese Parents
Learning to navigate the US health system is challenging for many new immigrants. This pilot study will determine whether an intervention to teach parents key skills needed to access health care for children is feasible and acceptable to immigrant parents.
This study will also look for evidence of efficacy to inform the planning process for future, larger evaluations of the intervention (i.e., estimate effect sizes).
Read the detailed description
Parents-particularly those with limited English proficiency (LEP) and limited literacy-may require months or years of experiential learning to master fundamental health care navigation tasks, such as requesting an interpreter. Most programs teaching health care navigation skills are ad hoc and have not be evaluated.
In this study, Investigators will pilot a group-based educational intervention in which a bilingual community health worker will use an interactive curriculum to teach immigrant parents key skills needed to access health care for children.
Parents and caregivers for children <18 years will be enrolled in closed groups of 6-12 individuals. The 6-12 week intervention will comprise 6 meetings, each of which will be no longer than 75 minutes. Each meeting will focus on one of six skills:
- Requesting an interpreter;
- Communicating with a health care facility by telephone;
- Scheduling appointments;
- Traveling to health care facilities and registering with the front desk;
- Obtaining appointments with specialists;
- Calling 911 for an ambulance.
Each meeting will follow a pre-specified plan that will typically include welcoming activities, a review of prior material, introduction of new material, and a series of activities (e.g., role play) to practice key skills. Sessions will be interactive, culturally-appropriate, and held in parents' preferred language.
- Being tested
- Group-based educational intervention
- Keywords
- Refugee Health, Immigrant Health, Health care navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based educational interventionOther
The group-based educational intervention will use a bilingual Community Health Worker (CHW) who will teach parents key skills needed to access health care for children. Parents will be invited to attend 6 small, closed-group sessions held over 12 weeks and lasting no more than 75 minutes. Sessions will be interactive, culturally-appropriate, and held in parents' preferred language.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare navigation workshops | Experimental | All enrolled caregivers and parents will partake in the group-based educational intervention. Receives: Other: Group-based educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects enrolling in study and completing study visits
Enrollment of the target sample and completion of the planned study visits by participants
Measured: 9 months
Secondary outcomes (1)
Change in retainment of health care navigation skills from baseline
Change in Health Care Navigation Inventory (HCNI) Skills Subscale scores from baseline to post-intervention study visits. Scores can range from 12 to 60, with higher scores indicating better outcomes.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start17 Dec 2018
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immigrant Caregiver Health Care Navigation for ChildrenStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Katherine Yun, MD MHS, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719976
- Sponsor's protocol ID
- 18-015474
- Other IDs
- 1K23HD082312-01A1
- Status last verified
- Jan 2023
- First submitted
- 23 Oct 2018
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prepared Parents Helping Kids: Teaching Health Care Navigation for Bhutanese Parents
- ClinicalTrials.gov ID
- NCT03719976
- Acronym / sponsor ID
- 18-015474
- Keywords
- Refugee Health, Immigrant Health, Health care navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 25 Oct 2018 (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.
Learning to navigate the US health system is challenging for many new immigrants. This pilot study will determine whether an intervention to teach parents key skills needed to access health care for children is feasible and acceptable to immigrant parents.
This study will also look for evidence of efficacy to inform the planning process for future, larger evaluations of the intervention (i.e., estimate effect sizes).
Detailed description
Parents-particularly those with limited English proficiency (LEP) and limited literacy-may require months or years of experiential learning to master fundamental health care navigation tasks, such as requesting an interpreter. Most programs teaching health care navigation skills are ad hoc and have not be evaluated.
In this study, Investigators will pilot a group-based educational intervention in which a bilingual community health worker will use an interactive curriculum to teach immigrant parents key skills needed to access health care for children.
Parents and caregivers for children <18 years will be enrolled in closed groups of 6-12 individuals. The 6-12 week intervention will comprise 6 meetings, each of which will be no longer than 75 minutes. Each meeting will focus on one of six skills:
- Requesting an interpreter;
- Communicating with a health care facility by telephone;
- Scheduling appointments;
- Traveling to health care facilities and registering with the front desk;
- Obtaining appointments with specialists;
- Calling 911 for an ambulance.
Each meeting will follow a pre-specified plan that will typically include welcoming activities, a review of prior material, introduction of new material, and a series of activities (e.g., role play) to practice key skills. Sessions will be interactive, culturally-appropriate, and held in parents' preferred language.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare navigation workshops | Experimental | Other: Group-based educational interventionAll enrolled caregivers and parents will partake in the group-based educational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult age 18 years or older
- Parent of a child <18 years
- Nepali-speaking
- Resident of the US for <10 years
Key exclusion criteria (1 listed)
- Scheduled to move away from the study location (e.g., to another city) before the end of the 6-session intervention
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 |
|---|---|---|
| Group-based educational interventionThe group-based educational intervention will use a bilingual Community Health Worker (CHW) who will teach parents key skills needed to access health care for children. Parents will be invited to attend 6 small, closed-group sessions held over 12 weeks and lasting no more than 75 minutes. Sessions will be interactive, culturally-appropriate, and held in parents' preferred language. | Other | Healthcare navigation workshops |
Primary outcome
Number of subjects enrolling in study and completing study visits
Time frame: 9 months
Enrollment of the target sample and completion of the planned study visits by participants
1 secondary outcome
Change in retainment of health care navigation skills from baseline
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Katherine Yun, MD MHS principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based educational intervention in people with Immigrant Caregiver Health Care Navigation for Children, run by Children's Hospital of Philadelphia at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects enrolling in study and completing study visits (time frame: 9 months). 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 10 Jan 2023.