Low Income Families Basic Social NeedsNCT01303458
Addressing Low-Income Families' Basic Social Needs at Pediatric Visits
A study testing Basic Needs Surveillance (BNS) protocol in people with Low Income Families Basic Social Needs, run by Boston Medical Center at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Income Families Basic Social Needs
- What is being tested?
- Basic Needs Surveillance (BNS) protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Arvin Garg
Boston, Massachusetts, 02118
Harvard Street Neighborhood Health Center
Dorchester, Massachusetts, 02121
Dorchester House Multi-Service Center
Dorchester, Massachusetts, 02122
Neponset Health Center
Dorchester, Massachusetts, 02122
Codman Square Health Center
Dorchester, Massachusetts, 02124
Upham's Corner Health Center
Dorchester, Massachusetts, 02125
Greater Roslindale Medical and Dental Center
Roslindale, Massachusetts, 02131
The Dimock Center
Roxbury, Massachusetts, 02119
South Boston Community Health Center
South Boston, Massachusetts, 02127
About this study
Official title: 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.
Read more
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.
- Conditions
- Low Income Families Basic Social Needs
- Being tested
- Basic Needs Surveillance (BNS) protocol
- Keywords
- community resource, well-child care visit, low-income
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Needs Surveillance (BNS) protocolBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Study subjects will receive the Basic Needs Surveillance (BNS) intervention. Receives: Behavioral: Basic Needs Surveillance (BNS) protocol |
| Control arm | No intervention | Study subjects in the control arm will receive the standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment in new community-based resources and services
Measured: when index child is 1 yr of age
Secondary outcomes (7)
Food insecurity
Measured: when index child is one yr of age
Maternal depression
Measured: when index child is one yr of age
preventative care adherence, child health, child maltreatment
Measured: 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)
Measured: 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)
Measured: child is 9 months of age
unmet basic needs
food, housing, employment, education, childcare, heat
Measured: 12 month follow-up
parenting stress, maternal life satisfaction
Measured: 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Income Families Basic Social NeedsStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Arvin Garg, Boston Medical Center
- Investigators
- Arvin Garg, MD, MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303458
- Sponsor's protocol ID
- 4R00HD056160-02
- Other IDs
- 4R00HD056160-02
- Status last verified
- Jan 2017
- First submitted
- 23 Feb 2011
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25560448
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Low-Income Families' Basic Social Needs at Pediatric Visits: the WE CARE Project
- ClinicalTrials.gov ID
- NCT01303458
- Acronym / sponsor ID
- 4R00HD056160-02
- Conditions
- Low Income Families Basic Social Needs
- Keywords
- community resource, well-child care visit, low-income
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Basic Needs Surveillance (BNS) protocolStudy subjects will receive the Basic Needs Surveillance (BNS) intervention. |
| Control arm | No intervention | –Study subjects in the control arm will receive the standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Needs Surveillance (BNS) protocolThe 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 | Behavioural | Intervention arm |
Primary outcome
Enrollment in new community-based resources and services
Time frame: when index child is 1 yr of age
7 secondary outcomes
Food insecurity
Time frame: when index child is one yr of age
Maternal depression
Time frame: when index child is one yr of age
preventative care adherence, child health, child maltreatment
Time frame: when index child is one yr of age
referrals received by mother at index well-child care visit
Time frame: 1st well-child care visit
contact of community resource
Time frame: child is 9 months of age
unmet basic needs
Time frame: 12 month follow-up
parenting stress, maternal life satisfaction
Time frame: 12 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Derived from this study: PubMed 25560448Garg 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arvin Garg, MD, MPH principal investigator
Boston Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Needs Surveillance (BNS) protocol in people with Low Income Families Basic Social Needs, run by Boston Medical Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment in new community-based resources and services (time frame: when index child is 1 yr of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01303458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2017.