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

Addressing Low-Income Families' Basic Social Needs at Pediatric Visits: the WE CARE Project

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.

Study Overview

• Status: Completed
• Conditions: Low Income Families Basic Social Needs
• Intervention / Treatment: Behavioral: Basic Needs Surveillance (BNS) protocol

• Study Type: Interventional
• Enrollment (Actual): 336
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Arvin Garg
    • Dorchester, Massachusetts, United States, 02124
      • Codman Square Health Center
    • Dorchester, Massachusetts, United States, 02125
      • Upham's Corner Health Center
    • Dorchester, Massachusetts, United States, 02122
      • Dorchester House Multi-Service Center
    • Dorchester, Massachusetts, United States, 02121
      • Harvard Street Neighborhood Health Center
    • Dorchester, Massachusetts, United States, 02122
      • Neponset Health Center
    • Roslindale, Massachusetts, United States, 02131
      • Greater Roslindale Medical and Dental Center
    • Roxbury, Massachusetts, United States, 02119
      • The Dimock Center
    • South Boston, Massachusetts, United States, 02127
      • South Boston Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Enrollment in new community-based resources and services	when index child is 1 yr of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food insecurity		when index child is one yr of age
Maternal depression		when index child is one yr of age
preventative care adherence, child health, child maltreatment		when index child is one yr of age
referrals received by mother at index well-child care visit	referrals received for any of the 6 following unmet needs (food, housing, employment, education, childcare, heat)	1st well-child care visit
contact of community resource	self-report of contact of a community resource for one of the 6 unmet needs (food, housing, employment, childcare, education, heat)	child is 9 months of age
unmet basic needs	food, housing, employment, education, childcare, heat	12 month follow-up
parenting stress, maternal life satisfaction		12 month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
unmet basic needs	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.	at enrollment

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Arvin Garg, MD, MPH, Boston Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): January 5, 2017
• Last Update Submitted That Met QC Criteria: January 4, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: low-income; well-child care visit; community resource
• Other Study ID Numbers: 4R00HD056160-02 (U.S. NIH Grant/Contract)