Clinical trial NCT06323967: Growing Strong Study of Unconditional Cash Transfers Plus Peer Support for Families With Babies in Homeless Shelters
Official title: Growing Strong Study of Unconditional Cash Transfers Plus Voluntary Peer Support to Reduce Shelter Stays and Improve Family Well-being for Families With Babies in New York City Homeless Shelters
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Time to Shelter Exit
Family Well-being
Child Well-being
Keywords: family homelessness
direct cash transfer
unconditional cash transfer
housing affordability
income inequality
child poverty
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Women in Need (Win)
name: The Samuels Group
name: New York City Center for Innovation through Data Intelligence (CIDI)
First posted: 2024-03-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment to 1) active treatment and 2) active comparison. A third, passive comparison group will be constructed and followed anonymously via administrative records.
Primary purpose: TREATMENT

Brief summary: The Growing Strong program tests a novel approach to helping families with young children living in homeless shelters, namely offering guaranteed, unconditional cash gifts that families can use as they wish plus voluntary peer support. The assumption behind this approach is that families know best how to allocate resources to meet their own individual needs. While there are a number of Direct Cash Transfer studies taking place around the country, the investigator(s) are unaware of any that have tested the relationship of receiving cash on homelessness among families specifically. To be eligible to participate in the study, families must reside in a homeless shelter and have at least one child under two years of age living with them in shelter. The investigator(s) have tied eligibility to the age of the youngest child in the household because rates of shelter use are highest among this population and because the costs associated with young children increase such families' financial burdens.

A total of 200 families will be enrolled in the study. One hundred families in the active intervention group will receive $1,500 per month ("substantial cash") for 24 months ($18,000 annually) and may also elect to receive peer support services. One hundred families in the active comparison group will receive $50 per month ("nominal cash") for 24 months ($600 annually) and will not have access to the peer support services. A third, passive comparison group will receive usual care within the homeless shelter system in the same metropolitan area (New York City) as participants in both cash gift groups. This group of families will be followed only in administrative records.

The main research questions are: does providing substantial, unconditional cash transfers plus access to voluntary peer support services over 24 months a) reduce the length of time in shelter for families with young children and/or b) improve other aspects of family and child well-being relative to providing nominal cash transfers alone or usual care.

Detailed description: In the Growing Strong study, 200 families residing in the Women in Need (Win) homeless shelter system who have at least one child under two years of age living with them in shelter and who have been found "eligible" for shelter by New York City will participate. Families will be assigned to one of two cash gift conditions. One hundred families will be assigned to the active intervention group and will receive $1,500 per month via debit card for 24 months ($18,000 annually) to use as they wish along with access to free, voluntary peer support services. One hundred families will be assigned to the active comparison group and receive $50 per month via debit card for 24 months ($600 annually) to use as they wish but will not have access to the peer support services. A passive comparison group will be constructed from the administrative data of propensity-matched families within in the New York City homeless shelter system who would have met the criteria to participate in the study had they resided in one of the Win target shelters. This study is funded by a grant to Win from a private foundation, thus all target shelters are operated by Win.

Design

The Growing Strong study design is quasi-experimental with intentional assignment at the shelter level rather than experimental with random assignment at the family or shelter level for several reasons. Participants were not randomized at the family level in order to eliminate the possibility that comparably situated families living in the same shelter could enroll in the study and yet receive very different cash amounts. Participants were not randomized at the shelter level because there were too few shelters in the final design (three) for randomization to balance the characteristics of families across conditions in expectation. The overall sample size for families was limited by the substantial cost of the intervention (between $600 - $18,000 plus costs of peer support annually per family).

Families can be assigned to treatment conditions based on their shelter placements because New York City makes placement decisions in a quasi-random fashion based on the availability and size of shelter rooms/apartments. Accordingly, the investigator(s) have selected three shelters within the Win shelter system that are as closely matched as possible on room sizes and other characteristics that affect placements. All families in the two smaller shelters (which are geographically proximal to one another) will be assigned to one study condition. Those at the larger shelter (which is farther away) will be assigned to the other study condition. The underlying, quasi-random City placement process should equate the two groups in expectation. The investigator(s) will check whether families in the two groups are in fact well-matched and control for any differences between them during analysis if needed.

Procedures

As the shelter operator, Win has information about families who are deemed eligible for shelter, including information to determine whether a family meets the Growing Strong eligibility criteria. Win administrative staff will notify the Win staff member who is the liaison to the study when a family meets the criteria to participate. This staff member will explain the study to families. Families who meet the criteria and would like to learn more will be referred for potential enrollment.

Families who choose to enroll will take part in a baseline survey and be invited to participate in follow-up surveys 6, 18 and 30 months later. The baseline survey collects data on demographic characteristics, family composition, work experience, income, finances, adult health and well-being (including use of alcohol and drugs), food security, social support, parenting, family routines, and child development. Measures refer to the adult participant (typically the mother), the family as a whole, or the young child who makes the family eligible for the study (the target child). Follow-up surveys mostly consist of the same measures taken at baseline plus additional information about housing and neighborhoods. The 30-month follow-up survey, which will take place 6 months after the family has stopped receiving cash, will also examine how the family is faring without the cash support.

The research team will conduct qualitative interviews with 15 families in each of the active study groups. These 30 families will be representative of the overall sample with respect to demographic characteristics. The qualitative interviews will ask about respondents' experiences in the study, including the cash (e.g., what they used it for, how it changed things for them) and the peer support services (e.g., did services help them to get out of shelter and, if so, how). In addition to probing the topics in the quantitative surveys, qualitative interviews will ask about respondents' goals and family processes. Qualitative interviews will take place 6, 18, and 30 months after enrollment.

Families who choose to enroll in the study will provide consent for us to collect administrative data for members of their household from various state and local agencies. Administrative data will include length of stay in shelters, returns to shelter, involvement with child protective services, income from employment, and emergency and routine health care, among other things. Administrative data will be used to compare outcomes for the families enrolled in Growing Strong to those of similar families outside of the study who receive usual care in the New York City homeless shelter system. Administrative data will be collected by New York City's Center for Innovation through Data Intelligence (CIDI).

Safeguards

Growing Strong has received a waiver from New York State that exempts cash gifts from the study in income calculations for benefits provided or mediated by the state (e.g., TANF) for as long as the participant is enrolled. Though families are not expected to withdraw from the study, they may do so at any time, effectively ending the protection of the waiver if they choose to continue to receive the cash gifts (which are unconditional) after withdrawal.

In an effort to hold families harmless, the investigator(s) have developed procedures that protect families' benefits under the waiver to the greatest extent possible. More specifically, the research team will wait to collect all administrative data except shelter exit time until after families have received their cash gifts in full (e.g., after 24 months of participation). Thus, any families who wish to withdraw from the study can time the withdrawal to occur after receiving the final cash gift but before administrative data are pulled for their household. A dedicated Win staff member will help families who choose to withdraw with the timing of withdrawal in order to protect/preserve their benefits under the waiver. Though the study has this safeguard in place, families are not expected to choose to withdraw from the study.

The study has also been granted a Certificate of Confidentiality from the National Institutes of Health. This means that the study cannot release or use information that identifies families in any action or suit without the agreement of the family. This protection includes civil, criminal, administrative, and/or legislative proceedings at the federal, state, and/or local level.

Outcomes

The primary outcome is length of time between families' being found eligible for shelter and shelter exit assessed with survival analysis (Cox proportional hazards).

The investigator(s) will test for differences between the active intervention and active comparison groups on additional outcomes at each follow-up point controlling for race and language of interview as covariates. If the majority of participants are not women, as anticipated, analyses will also include controls for gender. If overall differences between groups at baseline exceed chance estimates, analyses will control for baseline measures that differ beyond p \< .1. If follow-up rates fall below 90%, analyses will also control for propensity to respond to follow-up surveys in order to account for any differential attrition.

Following the practices of other studies of interventions to assist families experiencing homelessness, analyses will use a .10 level for statistical significance and not adjust for multiple testing. To avoid preferential selection of outcomes ("cherry-picking"), the investigator(s) have designated a single primary outcome and one or at most two measures per outcome domain as "key secondary outcomes" to feature in all reports.

Following the 30-month/final follow-up interview, the investigator(s) will use hierarchical linear models with time points (max = 4) nested within respondents to examine trends over time. Increases in most measures of well-being are expected as families in both groups stabilize in housing as well as treatment-by-time interactions showing the superiority of outcomes for the active intervention group.

Secondary Outcome Notation

Secondary outcomes have been pre-specified and grouped into the following nine domains: Housing, Target Child Development, Parenting, Family Separation, Adult Well-Being, Domestic Violence, Financial Well-Being, Employment, and Health Care. Secondary outcomes are labeled as follows in subsequent sections of the pre-registration: Domain names are prepended to outcome names and an asterisk is appended to outcomes designated as "key" secondary outcomes. For example, the key secondary outcome "Family Use of Emergency Medical Care or Hospitalization" is labeled "Health Care: Family Use of Emergency Medical Care or Hospitalization\*."

Eligibility criteria: Note that New York City has a right to shelter. When a family applies for shelter, the City assigns them to a shelter temporarily while City workers determine whether the family is truly homeless. If so, the City will deem the family "eligible" for shelter. If not, the family must leave.

Inclusion Criteria:

* A family has been found "eligible" for shelter (as described above) within the past 30 days
* The family has a baby who meets the age criteria (under 2 years of age)
* There is an adult 18 or over who has custody of the child (typically the mother)
* The family speaks English or Spanish
* The family lives in a designated Win shelter

Exclusion Criteria:

* None: any family configuration is permissible

Primary outcomes:
measure: Time to shelter exit
timeFrame: 18 months
Secondary outcomes:
measure: Housing: Total time in shelter*
timeFrame: 30 months
measure: Housing: Housing Stability
timeFrame: 6 months to 30 months
measure: Target Child Development: Child Behavior Problems*
timeFrame: 30 months
measure: Target Child Development: Child Prosocial Behavior*
timeFrame: 30 months
measure: Target Child Development: Child Verbal Development
timeFrame: Baseline to 30 months
measure: Parenting: Chaos in the Home*
timeFrame: Baseline to 30 months
measure: Parenting: Early Learning Activities with Target Child*
timeFrame: 6 months to 30 months
measure: Parenting: Target-Child-Focused Expenditure Index
timeFrame: 6 months to 30 months
measure: Parenting: Household Routines
timeFrame: Baseline to 30 months
measure: Parenting: Parenting Stress
timeFrame: Baseline to 30 months
measure: Family Separation: Separation of Parent and Target Child (Cumulative at any time point)*
timeFrame: 6 months to 30 months
measure: Family Separation: Indicated Investigations, Preventive services, or Child Placement of Target Child by Child Protective Services (No/Yes)
timeFrame: 30 months
measure: Adult Well-Being: Adult Psychological Distress*
timeFrame: Baseline to 30 months
measure: Adult Well-Being: Adult Alcohol or Drug Abuse
timeFrame: Baseline to 30 months
measure: Adult Well-Being: Hope
timeFrame: Baseline to 30 months
measure: Domestic Violence: Adult Domestic Violence*
timeFrame: Baseline to 30 months
measure: Financial Well-Being: Food Insecurity*
timeFrame: Baseline to 30 months
measure: Financial Well-Being: Adult Economic Stress
timeFrame: Baseline to 30 months
measure: Financial Well-Being: Financial Well-Being as Measured by the Consumer Financial Protection Bureau Financial Well-Being Scale
timeFrame: Baseline to 30 months
measure: Financial Well-Being: Financial Hardship as Measured by the Urban Institute Well-Being and Basic Needs Survey
timeFrame: Baseline to 30 months
measure: Employment: Income from Employment in Most Recent Period*
timeFrame: 30 months
measure: Employment: Adult Work for Pay
timeFrame: Baseline to 30 months
measure: Health Care: Family Use of Emergency Medical Care or Hospitalization (Cumulative at any point)*
timeFrame: 30 months
measure: Health Care: Proportion of Target Child Immunizations Recommended by Age by the American Academy of Pediatrics
timeFrame: 30 months
measure: Health Care: Proportion of Well-Child Visits by Target Child Recommended by Age by the American Academy of Pediatrics
timeFrame: 30 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Win NYC Shelter System
state: New York
Study officials:
affiliation: Vanderbilt University
name: Marybeth Shinn, PhD
role: PRINCIPAL_INVESTIGATOR
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