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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Arvin Garg, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01303458
First received: February 23, 2011
Last updated: April 1, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Enrollment in new community-based resources and services [ Time Frame: when index child is 1 yr of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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, child health, child maltreatment [ Time Frame: when index child is one yr of age ] [ Designated as safety issue: No ]
  • referrals received by mother at index well-child care visit [ Time Frame: 1st well-child care visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    food, housing, employment, education, childcare, heat

  • parenting stress, maternal life satisfaction [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • unmet basic needs [ Time Frame: at enrollment ] [ Designated as safety issue: No ]
    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.


Enrollment: 336
Study Start Date: January 2011
Study Completion Date: June 2013
Primary Completion Date: May 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303458

Locations
United States, Massachusetts
Arvin Garg
Boston, Massachusetts, United States, 02118
Codman Square Health Center
Dorchester, Massachusetts, United States, 02124
Dorchester House Multi-Service Center
Dorchester, Massachusetts, United States, 02122
Upham's Corner Health Center
Dorchester, Massachusetts, United States, 02125
Harvard Street Neighborhood Health Center
Dorchester, Massachusetts, United States, 02121
Neponset Health Center
Dorchester, Massachusetts, United States, 02122
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
Investigators
Principal Investigator: Arvin Garg, MD, MPH Boston Medical Center
  More Information

No publications provided

Responsible Party: Arvin Garg, Assistant Professor of Pediatrics, 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: April 1, 2014
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 October 30, 2014