Addressing Low-Income Families' Basic Social Needs at Pediatric Visits
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Purpose
This research project is aimed to address low-income families' basic social needs (housing, food, employment, education, childcare, utilities) within the context of pediatric primary care. This project builds upon the PI's prior study at Hopkins which demonstrated a positive impact of a similar intervention on pediatric residents' screening and referral to community agencies. This study will specifically test whether a further strengthened intervention--Basic Needs Surveillance (BNS) protocol-- can lead to greater maternal enrollment in community resources and receipt of eligible benefits. In addition, we will measure the intervention's impact on maternal well-being, and compliance with well-child care (WCC) visits.
The project will take place at eight community health centers in the Greater Boston Area. The centers will be randomized to either an intervention or control site. Mothers who bring their infant in for a WCC visit from birth to 6 months will be eligible. They will be followed until their child is one year of age. Study subjects will complete two self-administered surveys (baseline, follow-up), and one brief telephone interview (when their infant is 9 months old). Pediatric providers will also be subjects; and will fill out a demographic questionnaire at the time of enrollment.
The BNS intervention will consist of 4 components: 1) WE CARE survey which mothers will fill out in the waiting room prior to their child's WCC visits; 2) Family Resource book containing 1-page information sheets on resources, that providers will have access to in exam rooms; 3) a Community Resource Coordinator who will assist families link to available resources, and update providers; 4) Training Session which will provide a 1 hr overview of the intervention to providers.
Families attending the control health centers will receive standard of care. Enrolled mothers will be offered the intervention at the end of the 12-month follow-up interview. When follow-up data collection is complete, the PI will offer the control sites the opportunity to implement the BNS protocol.
| Condition | Intervention |
|---|---|
|
The Focus of This Study is to Address Low-income Families' Basic Social Needs at Pediatric Visits. |
Behavioral: Basic Needs Surveillance (BNS) protocol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Addressing Low-Income Families' Basic Social Needs at Pediatric Visits: the WE CARE Project |
- Enrollment in community-based resources and services [ Time Frame: when index child is 1 yr of age ] [ Designated as safety issue: No ]
- Food insecurity [ Time Frame: when index child is one yr of age ] [ Designated as safety issue: No ]
- Maternal depression [ Time Frame: when index child is one yr of age ] [ Designated as safety issue: No ]
- preventative care adherence and child health [ Time Frame: when index child is one yr of age ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 336 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention arm
Study subjects will receive the Basic Needs Surveillance (BNS) intervention.
|
Behavioral: Basic Needs Surveillance (BNS) protocol
The BNS intervention will consist of 4 components: 1) WE CARE survey which mothers will fill out in the waiting room prior to their child's WCC visits; 2) Family Resource book containing 1-page information sheets on resources, that providers will have access to in exam rooms; 3) a Community Resource Coordinator who will assist families link to available resources, and update providers; 4) Training Session which will provide a 1 hr overview of the intervention to providers
|
|
No Intervention: Control arm
Study subjects in the control arm will receive the standard of care.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Mothers (18 yrs or older) who bring their infant between the ages of birth and 6 months for a well-child care visit
- Medical providers who provide care to pediatric patients at the participating community health centers
Exclusion Criteria:
- Foster parent
- Mothers who anticipate changing their infant's site for care
- Mothers who are non-English or non-Spanish speaking
- Infants with hx of prematurity (born before 32 weeks)
- Infants with chronic cardiac or respiratory diseases
- Previously enrolled mother
Contacts and Locations| Contact: Arvin Garg, MD, MPH | 617-414-3817 | arvin.garg@bmc.org |
| United States, Massachusetts | |
| Arvin Garg | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Principal Investigator: Arvin Garg, MD | |
| Codman Square Health Center | Recruiting |
| Dorchester, Massachusetts, United States, 02124 | |
| Dorchester House Multi-Service Center | Recruiting |
| Dorchester, Massachusetts, United States, 02122 | |
| Harvard Street Neighborhood Health Center | Recruiting |
| Dorchester, Massachusetts, United States, 02121 | |
| Upham's Corner Health Center | Recruiting |
| Dorchester, Massachusetts, United States, 02125 | |
| Neponset Health Center | Recruiting |
| Dorchester, Massachusetts, United States, 02122 | |
| Greater Roslindale Medical and Dental Center | Recruiting |
| Roslindale, Massachusetts, United States, 02131 | |
| The Dimock Center | Recruiting |
| Roxbury, Massachusetts, United States, 02119 | |
| South Boston Community Health Center | Recruiting |
| South Boston, Massachusetts, United States, 02127 | |
| Principal Investigator: | Arvin Garg, MD, MPH | Boston Medical Center |
More Information
No publications provided
| Responsible Party: | Arvin Garg, MD, Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT01303458 History of Changes |
| Other Study ID Numbers: | 4R00HD056160-02, 4R00HD056160-02 |
| Study First Received: | February 23, 2011 |
| Last Updated: | February 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Boston Medical Center:
|
community resource well-child care visit low-income |
ClinicalTrials.gov processed this record on May 21, 2013