Addressing Low-Income Families' Basic Social Needs at Pediatric Visits
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ClinicalTrials.gov Identifier: NCT01303458 |
Recruitment Status
:
Completed
First Posted
: February 24, 2011
Last Update Posted
: January 5, 2017
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Low Income Families Basic Social Needs | Behavioral: Basic Needs Surveillance (BNS) protocol | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 336 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Addressing Low-Income Families' Basic Social Needs at Pediatric Visits: the WE CARE Project |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | June 2013 |
Arm | Intervention/treatment |
---|---|
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.
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- Enrollment in new community-based resources and services [ Time Frame: when index child is 1 yr of age ]
- Food insecurity [ Time Frame: when index child is one yr of age ]
- Maternal depression [ Time Frame: when index child is one yr of age ]
- preventative care adherence, child health, child maltreatment [ Time Frame: when index child is one yr of age ]
- referrals received by mother at index well-child care visit [ Time Frame: 1st well-child care visit ]referrals received for any of the 6 following unmet needs (food, housing, employment, education, childcare, heat)
- contact of community resource [ Time Frame: child is 9 months of age ]self-report of contact of a community resource for one of the 6 unmet needs (food, housing, employment, childcare, education, heat)
- unmet basic needs [ Time Frame: 12 month follow-up ]food, housing, employment, education, childcare, heat
- parenting stress, maternal life satisfaction [ Time Frame: 12 month follow-up ]
- unmet basic needs [ Time Frame: at enrollment ]Questions from Children's HealthWatch survey used to measure 6 needs: food insecurity (18-item US food security scale), housing instability, education i.e., not completed high school, childcare, heat, employment.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303458
United States, Massachusetts | |
Arvin Garg | |
Boston, Massachusetts, United States, 02118 | |
Harvard Street Neighborhood Health Center | |
Dorchester, Massachusetts, United States, 02121 | |
Dorchester House Multi-Service Center | |
Dorchester, Massachusetts, United States, 02122 | |
Neponset Health Center | |
Dorchester, Massachusetts, United States, 02122 | |
Codman Square Health Center | |
Dorchester, Massachusetts, United States, 02124 | |
Upham's Corner Health Center | |
Dorchester, Massachusetts, United States, 02125 | |
Greater Roslindale Medical and Dental Center | |
Roslindale, Massachusetts, United States, 02131 | |
The Dimock Center | |
Roxbury, Massachusetts, United States, 02119 | |
South Boston Community Health Center | |
South Boston, Massachusetts, United States, 02127 |
Principal Investigator: | Arvin Garg, MD, MPH | Boston Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Arvin Garg, Assistant Professor of Pediatrics, Boston Medical Center |
ClinicalTrials.gov Identifier: | NCT01303458 History of Changes |
Other Study ID Numbers: |
4R00HD056160-02 ( U.S. NIH Grant/Contract ) |
First Posted: | February 24, 2011 Key Record Dates |
Last Update Posted: | January 5, 2017 |
Last Verified: | January 2017 |
Keywords provided by Arvin Garg, Boston Medical Center:
community resource well-child care visit low-income |