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Completed

NCT Number: NCT01303458

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arvin Garg, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basic Needs Surveillance (BNS) protocol

Behavioral

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

Primary outcomes

  1. Enrollment in new community-based resources and services

    Time frame: when index child is 1 yr of age

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 24, 2011
Registry last updated
Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.