Addressing Low-Income Families' Basic Social Needs at Pediatric Visits

Study Description

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Brief Summary:

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Primary Outcome Measures :

1. Enrollment in new community-based resources and services [ Time Frame: when index child is 1 yr of age ]

Secondary Outcome Measures :

1. Food insecurity [ Time Frame: when index child is one yr of age ]
2. Maternal depression [ Time Frame: when index child is one yr of age ]
3. preventative care adherence, child health, child maltreatment [ Time Frame: when index child is one yr of age ]
4. 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)
5. 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)
6. unmet basic needs [ Time Frame: 12 month follow-up ]
   food, housing, employment, education, childcare, heat
7. parenting stress, maternal life satisfaction [ Time Frame: 12 month follow-up ]

Other Outcome Measures:

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

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Locations

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

Sponsors and Collaborators

Boston Medical Center

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:	Arvin Garg, MD, MPH	Boston Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Garg A, Toy S, Tripodis Y, Silverstein M, Freeman E. Addressing social determinants of health at well child care visits: a cluster RCT. Pediatrics. 2015 Feb;135(2):e296-304. doi: 10.1542/peds.2014-2888. Epub 2015 Jan 5.

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
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