- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03719976
Prepared Parents Helping Kids
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).
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19148
- Bhutanese American Organization - Philadelphia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult age 18 years or older
- Parent of a child <18 years
- Nepali-speaking
- Resident of the US for <10 years
Exclusion Criteria:
- Scheduled to move away from the study location (e.g., to another city) before the end of the 6-session intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthcare navigation workshops
All enrolled caregivers and parents will partake in the group-based educational intervention.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in retainment of health care navigation skills from baseline
Time Frame: 9 months
|
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.
|
9 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Katherine Yun, MD MHS, Children's Hospital of Philadelphia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 18-015474
- 1K23HD082312-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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