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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03719976
Other study ID # 18-015474
Secondary ID 1K23HD082312-01A
Status Completed
Phase N/A
First received
Last updated
Start date December 17, 2018
Est. completion date September 1, 2022

Study information

Verified date January 2023
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


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: 1. Requesting an interpreter; 2. Communicating with a health care facility by telephone; 3. Scheduling appointments; 4. Traveling to health care facilities and registering with the front desk; 5. Obtaining appointments with specialists; 6. 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Immigrant Caregiver Health Care Navigation for Children

Intervention

Other:
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.

Locations

Country Name City State
United States Bhutanese American Organization - Philadelphia Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of subjects enrolling in study and completing study visits Enrollment of the target sample and completion of the planned study visits by participants 9 months
Secondary 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. 9 months