- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00397644
Assisting Low-Income Families at Pediatric Well-Child Care Visits
October 31, 2023 updated by: Johns Hopkins University
Enhancing a Medical Home for Vulnerable Children by Addressing Family Psychosocial Problems at Well-Child Care Visits: THE WE CARE Project
The objective of this study is to evaluate the impact and feasibility of a practice-based intervention on the discussion and referral of family psychosocial topics at well-child care visits at a medical home for low-income children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Many low-income families have family psychosocial problems such as unemployment, housing difficulties, and food insecurity.
Pediatric guidelines that pediatricians should be discussing and assisting these families.
However, to date few routine do.
The primary hypotheses for this study is that the WE CARE (Well-child care visit, Evaluation, Community resources, Advocacy, Referral, Education)intervention would increase the discussion and referral rates for family psychosocial problems at well-child care visits.
Study Type
Interventional
Enrollment
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Harriet Lane Clinic at Johns Hopkins Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Caregivers of children aged 2 months to 10 years who present for well-child care visit at a pediatric clinic
Exclusion Criteria:
- Non-English speaking
- Foster parents
- Previously enrolled parent
- No access to telephone
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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Discussion of family psychosocial problem
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Referral of family psychosocial problem
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Contacting community resources
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Arvin Garg, MD, MPH, Johns Hopkins School of Medicine
- Principal Investigator: Janet Serwint, MD, Johns Hopkins School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kalra N, Hooker L, Reisenhofer S, Di Tanna GL, Garcia-Moreno C. Training healthcare providers to respond to intimate partner violence against women. Cochrane Database Syst Rev. 2021 May 31;5(5):CD012423. doi: 10.1002/14651858.CD012423.pub2.
- Garg A, Butz AM, Dworkin PH, Lewis RA, Thompson RE, Serwint JR. Improving the management of family psychosocial problems at low-income children's well-child care visits: the WE CARE Project. Pediatrics. 2007 Sep;120(3):547-58. doi: 10.1542/peds.2007-0398.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Study Completion
June 1, 2006
Study Registration Dates
First Submitted
November 7, 2006
First Submitted That Met QC Criteria
November 7, 2006
First Posted (Estimated)
November 9, 2006
Study Record Updates
Last Update Posted (Actual)
November 1, 2023
Last Update Submitted That Met QC Criteria
October 31, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 20060351
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.