Clinical trial NCT04226053: Room to Grow Evaluation for Children
Official title: Comprehensive Early Childhood Parenting Supports and Children's Health and Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Child Development
Keywords: Poverty
Children
Social support
Practical support
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-01-13
Enrollment: 322
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This research project is a small-scale randomized controlled trial (RCT) of an innovative program based in New York City called Room to Grow (RtG). Room to Grow's mission is to enrich the lives of babies born into poverty throughout their critical first three years of development. The research-informed program model combines tailored, one-on-one sessions with an expert clinical social worker in-person every three months plus ongoing communication (via phone and email), provision of essential baby items, and connections to vital community resources. The goal of Room to Grow's innovative program is to help parents increase the probability that their children will enter school ready to learn and continue on to meet their full potential in education, work, and citizenship. The therapeutic, psychodynamic approach and robust three-year long relationship with families is designed to act as the catalyst for sustainable, long-term change in parenting methods and family system stability. Critically, and in contrast to other programs aimed at improving parenting and child development, Room to Grow believes that providing concrete material assistance enhances the effectiveness of counseling and referrals to low-income families by reducing economic stress and freeing up scarce resources.

Detailed description: The goal of RtG's innovative program is to help parents increase the probability that their children will enter school ready to learn and continue on to meet their full potential in education, work, and citizenship. The therapeutic, psychodynamic approach and robust three-year long relationship with families is designed to act as the catalyst for sustainable, long-term change in parenting methods and family system stability. Critically, and in contrast to other programs aimed at improving parenting and child development, RtG believes that providing concrete material assistance enhances the effectiveness of counseling and referrals to low-income families by reducing economic stress and freeing up scarce resources. The program builds on decades of research on the importance of parenting supports for low-income families and their children, the significance of concrete material support and poverty reduction in enhancing children's health and development, and the recognition that the early years are an effective time to provide critical supports that influence long-term outcomes. Numerous programs, such as home-visiting models that provide parenting supports to low-income new mothers have shown promising results. After decades of correlational research establishing relationships between income, poverty, and children's health and development, there is an emerging literature providing convincing causal evidence that income matters for child outcomes. Both strains of this research build upon additional research that clearly suggests early childhood is a key period of vulnerability where interventions can make a lasting difference in the fortunes of low-income children and their families. The research will build upon this literature, by testing an intervention that combines both parenting supports and meaningful provision of material support - in essence, assessing whether a combined approach can prove potentially more powerful than the sum of its parts.

The evaluation of RtG provides the unprecedented opportunity to test the combined value of parenting education with social and material supports. The project leverages an innovative approach that combines income supports, parenting education and connection to community services to promote the early health and development of young children. Both parenting and income support programs each aim to promote low- and moderate income families' positive health and development, but too often they work in isolation, potentially limiting their ability to reduce disparities in both parents' and children's health and development. RtG's innovative model provides an opportunity to test the combined effect of these services, and provide valuable information to practitioners and policy makers on the synergistic effects of these program components. The proposed research can facilitate change in the early childhood field by demonstrating preliminary evidence that this innovative model can achieve demonstrable effects on key proximal outcomes over the first year of life and provide a first step towards building the evidence for multi-pronged approaches to meeting the needs of low-income families. Findings from this study may guide the field towards more integrated approaches that combines material support, connection to resources, and parenting assistance to make real impacts in the health and development of young children. Room to Grow and its evaluation will provide clear contributions to the development of a culture of health and relevant policies in the early childhood space. This will be the first RCT that provides a combination of parenting and community supports with substantial and empowering provision of material support. Many parenting programs provide some developmentally appropriate books or toys, but it is incredibly rare to provide the retail equivalent of roughly $10,000 in support over the first three years of life. This will establish whether a model such as RtG's holds promise for transforming early childhood parenting programs in helping to build a culture of health and for reducing health disparities among children from divergent backgrounds. The organization and its leadership look forward to learning from the evaluation project in order to understand more about what's working well and what could be improved in the program delivery and curriculum. The team at RtG has purposefully created a culture that uses data to inform decision-making and looks forward to understanding the full scope of results from the RCT. RtG is currently developing plans for expansion over the next five years as part of a formal strategic planning process. The organization hopes to eventually serve double or more the number of families in each city where it operates, New York and Boston. Findings to date from internal evaluations are extremely encouraging. It is the researchers' hope that other foundations and government agencies (or private donors) will be excited to build upon support from the Robert Wood Johnson Foundation and that the researchers will be able to extend the initial momentum generated by this project over time.

The project is designed to investigate proximal outcomes. Over the long-term, the research team hopes to build upon these proximal outcomes and to eventually follow children through school-age, as well as greatly expand the number of children that are included in the RCT project.

Eligibility criteria: Inclusion Criteria:

* Female
* Must be at least 16 years old
* In third trimester (weeks 28-34) of pregnancy
* Meet Room to Grow program criteria
* Low-Income
* In need of services

Exclusion Criteria:

* Cannot read/write English and/or Spanish
* Male
* Past third trimester
* Already given birth
* Mid to high income

Primary outcomes:
measure: Change in Mean Score of Depressive Symptoms using the CES-D Scale
timeFrame: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
measure: Change in Mean Score of Perceived Stress Scale (PSS)
timeFrame: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
measure: Change in Mean Score of Parental Sense of Competence using PSOC Scale
timeFrame: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
measure: Change in Mean Score of the Confusion, Hubbub, and Order Scale (CHAOS)
timeFrame: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
measure: Change in Mean Score of Cognitive Stimulation in the Home (STIMQ)
timeFrame: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
measure: Change in Mean Score of Aggravation in Parenting Scale
timeFrame: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
measure: Number of Toys and Goods in the Home
timeFrame: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
measure: Worry Enough Money for Baby
timeFrame: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
measure: Change in mean score of Parent Supportiveness using the 3-bag task
timeFrame: At follow-up in-person meeting (42-72 months after birth of child)
measure: Change in mean score of Parent Detachment using 3 bag-task
timeFrame: At follow-up in-person meeting (42-72 months after birth of child)
measure: Change in Mean Score on Performance on Working Memory Span
timeFrame: At follow-up in-person meeting (42- 72 months after birth of child)
measure: Change in Mean Score on Inhibitory Motor Control Performance
timeFrame: At follow-up in-person meeting (42-72 months after birth of child)
measure: Change in Mean Score on Attention Shifting Performance
timeFrame: At follow-up in-person meeting (42-72 months after birth of child)
measure: Change in Language Total Standard Score
timeFrame: At follow-up in-person meeting (42-72 months after birth of child)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University - Columbia Population Research Center (CPRC)
state: New York
Study officials:
affiliation: Senior Research Scientist at CPRC, School of Social Work
name: Christopher Wimer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peacock S, Konrad S, Watson E, Nickel D, Muhajarine N. Effectiveness of home visiting programs on child outcomes: a systematic review. BMC Public Health. 2013 Jan 9;13:17. doi: 10.1186/1471-2458-13-17.
citation: Duncan GJ, Morris PA, Rodrigues C. Does money really matter? Estimating impacts of family income on young children's achievement with data from random-assignment experiments. Dev Psychol. 2011 Sep;47(5):1263-79. doi: 10.1037/a0023875.
citation: Chaudry A, Wimer C. Poverty is Not Just an Indicator: The Relationship Between Income, Poverty, and Child Well-Being. Acad Pediatr. 2016 Apr;16(3 Suppl):S23-9. doi: 10.1016/j.acap.2015.12.010.
citation: Duncan, G.J., Magnuson, K., Kalil, A. et al. Soc Indic Res (2012) 108: 87. https://doi.org/10.1007/s11205-011-9867-9
citation: Cates CB, Weisleder A, Mendelsohn AL. Mitigating the Effects of Family Poverty on Early Child Development through Parenting Interventions in Primary Care. Acad Pediatr. 2016 Apr;16(3 Suppl):S112-20. doi: 10.1016/j.acap.2015.12.015.
citation: Wimer C, Marti M, Brooks-Gunn J, Waldfogel J. Early Impacts of Room to Grow: A Multifaceted Intervention Supporting Parents and Children Age Zero to Three. Child Youth Serv Rev. 2021 Jul;126:106041. doi: 10.1016/j.childyouth.2021.106041. Epub 2021 Apr 30.