Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06323967
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-03-14
Brief Title:
Growing Strong Study of Unconditional Cash Transfers Plus Peer Support for Families With Babies in Homeless Shelters
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 investigators 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 investigators 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 1500 per month substantial cash for 24 months 18000 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 andor b improve other aspects of family and child well-being relative to providing nominal cash transfers alone or usual care
A total of 200 families will be enrolled in the study One hundred families in the active intervention group will receive 1500 per month substantial cash for 24 months 18000 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 andor 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 1500 per month via debit card for 24 months 18000 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 - 18000 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 roomsapartments Accordingly the investigators 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 investigators 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 eg what they used it for how it changed things for them and the peer support services eg 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 Citys 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 eg 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 investigators 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 eg 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 protectpreserve 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 andor legislative proceedings at the federal state andor 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 investigators 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 investigators 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-monthfinal follow-up interview the investigators 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
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 - 18000 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 roomsapartments Accordingly the investigators 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 investigators 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 eg what they used it for how it changed things for them and the peer support services eg 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 Citys 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 eg 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 investigators 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 eg 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 protectpreserve 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 andor legislative proceedings at the federal state andor 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 investigators 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 investigators 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-monthfinal follow-up interview the investigators 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None