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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

February 23, 2011
April 1, 2014
January 2011
May 2013   (final data collection date for primary outcome measure)
Enrollment in new community-based resources and services [ Time Frame: when index child is 1 yr of age ] [ Designated as safety issue: No ]
Enrollment in community-based resources and services [ Time Frame: when index child is 1 yr of age ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01303458 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
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.
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
The Focus of This Study is to Address Low-income Families' Basic Social Needs at Pediatric Visits.
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
  • Experimental: Intervention arm
    Study subjects will receive the Basic Needs Surveillance (BNS) intervention.
    Intervention: Behavioral: Basic Needs Surveillance (BNS) protocol
  • No Intervention: Control arm
    Study subjects in the control arm will receive the standard of care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
336
June 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01303458
4R00HD056160-02, 4R00HD056160-02
No
Arvin Garg, Boston Medical Center
Boston Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Arvin Garg, MD, MPH Boston Medical Center
Boston Medical Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP