Clinical trial NCT01303458: Addressing Low-Income Families' Basic Social Needs at Pediatric Visits
Official title: Addressing Low-Income Families' Basic Social Needs at Pediatric Visits: the WE CARE Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Income Families Basic Social Needs
Keywords: community resource
well-child care visit
low-income
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-02-24
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Enrollment in new community-based resources and services
timeFrame: when index child is 1 yr of age
Secondary outcomes:
measure: Food insecurity
timeFrame: when index child is one yr of age
measure: Maternal depression
timeFrame: when index child is one yr of age
measure: preventative care adherence, child health, child maltreatment
timeFrame: when index child is one yr of age
measure: referrals received by mother at index well-child care visit
timeFrame: 1st well-child care visit
measure: contact of community resource
timeFrame: child is 9 months of age
measure: unmet basic needs
timeFrame: 12 month follow-up
measure: parenting stress, maternal life satisfaction
timeFrame: 12 month follow-up
Other outcomes:
measure: unmet basic needs
timeFrame: at enrollment
Locations:
city: Boston
country: United States
facility: Arvin Garg
state: Massachusetts
city: Dorchester
country: United States
facility: Harvard Street Neighborhood Health Center
state: Massachusetts
city: Dorchester
country: United States
facility: Dorchester House Multi-Service Center
state: Massachusetts
city: Dorchester
country: United States
facility: Neponset Health Center
state: Massachusetts
city: Dorchester
country: United States
facility: Codman Square Health Center
state: Massachusetts
city: Dorchester
country: United States
facility: Upham's Corner Health Center
state: Massachusetts
city: Roslindale
country: United States
facility: Greater Roslindale Medical and Dental Center
state: Massachusetts
city: Roxbury
country: United States
facility: The Dimock Center
state: Massachusetts
city: South Boston
country: United States
facility: South Boston Community Health Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Arvin Garg, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.