ParentingRTGNCT04226053
Room to Grow Evaluation for Children
A study testing Parenting, Child Development in people with Parenting and Child Development, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parenting, Child Development
- What is being tested?
- Parenting, Child Development
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2017to 4 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cannot read/write English and/or Spanish
- Male
- Past third trimester
- Already given birth
- Mid to high income
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University - Columbia Population Research Center (CPRC)
New York, New York, 10032
About this study
Official title: Comprehensive Early Childhood Parenting Supports and Children's Health and Development
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.
Read the 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.
- Conditions
- Parenting, Child Development
- Being tested
- Parenting, Child Development
- Keywords
- Poverty, Children, Social support, Practical support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting, Child DevelopmentOther
The treatment group will consist of mothers that were randomly selected to receive Room to Grow services, which include three years of social and practical support for the mother and baby. The research-informed program model combines tailored, one-on-one sessions with an expert clinical social worker in-person every three months, provision of essential baby items including books, toys, clothing, and equipment (retail value of in-kind items over three years averages $10,000), and connections to vital community resources (e.g., housing, entitlements, child care, social services).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The treatment group will consist of mothers who were randomly selected to receive Room to Grow services, which include three years of social and practical support for the mother and baby through a combination of one-on-one sessions with an expert clinical social worker in-person every three months and provision of essential baby items and equipment. Receives: Other: Parenting, Child Development |
| Control Group | No intervention | The control group will consist of mothers who will not receive Room to Grow services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Score of Depressive Symptoms Using the CES-D Scale
The Center for Epidemiological Studies-Depression (CES-D), is a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
The Baseline and 25-month surveys included 12 items from the scale, and the 10.5-month survey included 7 items. The subscale scores range from 0 - 21 and 0 - 36, respectively. Higher scores indicate greater depressive symptoms.
Measured: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
Mean Score of Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) is a widely used instrument for measuring the perception of general stress. This 14-item scale measures how stressful or uncontrollable participants find their lives. Respondents rate the frequency of their feelings and thoughts related to events and situations that occurred in the last month. Individual scores on the PSS can range from 0-40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
The Baseline and 10.5-month surveys included 4 items from the scale. The 25-month survey included 6 items. Scores ranged from 0 - 16 and 0 - 24, respectively. Higher scores indicate higher perceived stress levels.
Measured: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
Mean Score of Parental Sense of Competence Using PSOC Scale
The Parenting Sense of Competence Scale (PSOC). The PSOC measures parental competence on two dimensions: Satisfaction and Efficacy. It is a 17-item Likert-scale questionnaire (on a 6-point scale ranging from strongly agree [1] to strongly disagree [6]), with nine questions under Satisfaction and eight under Efficacy. Satisfaction section examines the parents' anxiety, motivation and frustration, while the Efficacy section looks at the parents' competence, capability levels, and problem-solving abilities in their parental role. Scores range from 17-102. A higher score indicates a higher parenting sense of competency.
The Baseline and the 10.5-month surveys included 5 items from the scale with a modified 4-point scale ranging from strongly agree [1] to strongly disagree [4]. The 25-month survey included 8 items with the modified 4-point scale. Scores ranged from 4 - 20 and 4 - 32, respectively, with higher scores indicating a higher parenting sense of competency.
Measured: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
Mean Score of the Confusion, Hubbub, and Order Scale (CHAOS)
The Confusion, Hubbub, and Order Scale (CHAOS) is a questionnaire filled out by parents that is designed to assess the level of confusion and disorganization in the child's home environment. The statements are scored using a 4-point scoring system. The questionnaire consists of 15 statements, to each of which a parent or caregiver responds (1) True, or (0) False (scoring was adjusted for items that required reverse coding). Scores ranged from 0-15.
The Baseline and the 10.5-month surveys included 2 items from the scale with a modified 4-point scale ranging from 0 - 3: 0 = Not at all like your own home; 1 = A little bit like your own home; 2 = Somewhat like your own home; 3 = Very much like your own home. The 25-month survey included 5 items from the scale. Item scores were averaged and ranged from 0 - 3. A higher score represents characteristics of a more chaotic, disorganized, and hurried home.
Measured: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
Mean Score of Cognitive Stimulation in the Home (STIMQ)
STIMQ is a measure of cognitive stimulation in the home consisting of 4 subscales: Availability of Learning Materials (ALM), Reading, Parental Involvement in Developmental Advance (PIDA), and Parental Verbal Responsivity (PVR).
The 10-month \& 25-month surveys contained 4 of the 7 items in the PVR scale to measure cognitive stimulation. Respondents reported on the frequency of verbal responsiveness during everyday routines with their child.
The full PVR scale uses an 8-point response scale ranging from 0 (never) - 7 (every day) and total scores range from 0 - 49 for preschool-age children.
A modified 4-point response scale ranging from 1 (not at all) - 4 (every day). The average score of the four items was used and total scores ranged from 1-4. A higher score represents more responsivity and reflects greater stimulation in the home (a more favorable outcome).
Measured: 10.5 months after birth of child; 25 months after birth of child
Mean Score of Aggravation in Parenting Scale
A measurement of stress experienced by parents associated with caring for children. It measures the amount of parenting stress brought on by changes in employment, income or other factors in the parent's life. Research has shown that high levels of aggravation in parenting are related to mothers' employment status and to child behavior problems. High stress and aggravation in parents are associated with poor cognitive and socioemotional development of young children. 6 of the 9 items in the scale were included in the surveys. Response categories being (0) Strongly agree, (1) Somewhat agree, (2) Somewhat disagree, (3) Strongly disagree. This 0-3 score is reverse coded, and items are averaged to create an overall score with higher scores indicating more stress. Total scores ranged from 0-3.
Measured: 10.5 months after birth of child; 25 months after birth of child
Number of Toys and Goods in the Home
Subjects are asked if they have certain types of developmentally appropriate toys and games in the categories of symbolic play (doll, toy pots, small car), art (crayons, Play-Doh, paint), adaptive/fine motor toys (puzzle, shape sorter, pop-up toy), language (toy letters or numbers, toys that make animal sounds) and life-size toys (toy car or animal for child to ride). Respondents can answer yes/no for each (1=yes, 0=no). Subjects were asked about 13 items in the 10-month survey and 16 items in the 25-month survey. Items were replaced or supplemented for age-appropriateness at each wave. Item responses were tallied resulting in scores ranging from 0-13 and 0-16, respectively. A higher score or number of developmentally appropriate toys and goods in the home reflects a more favorable outcome for the child.
Measured: 10.5 months after birth of child; 25 months after birth of child
Worry Enough Money for Baby Scale Score
Subjects are asked to rate (on a scale of 1-10) how worried they are about having enough money to cover their baby's expenses with 1 being "Not at all worried" and 10 being "Very worried". A lower score indicates less concern and is therefore favorable.
Measured: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
Mean Score of Parent Supportiveness Using the 3-bag Task
The 3-bag task utilizes a semi-structured play protocol in which the parent-child dyad is instructed to play with the toys in each of three bags in a predetermined sequence. The semi-structured play interactions are videotaped and the parent-child behaviors scored in accordance with the 3-bag task coding scales used in the National Institute of Child Health and Human Development Study of Early Child Care. Parent supportiveness is the average of three measures: maternal sensitivity, positive affect, and the extent to which the parent provides cognitive stimulation while interacting with their child. Scoring for all three considers both the quantity and quality or intensity of behavioral indicators observed for each; a score of 1 represents virtually no evidence of the particular behavior and a score of 7 indicates very high levels of the behavior. As an average of the three, parent supportiveness follows the same scoring scheme and higher scores represent a more favorable outcome.
Measured: At follow-up in-person meeting (42-72 months after birth of child)
Mean Score of Parent Detachment Using 3 Bag-task
The 3-bag task utilizes a semi-structured play protocol in which the parent-child dyad is instructed to play with the toys in each of three bags in a predetermined sequence. The semi-structured play interactions are videotaped and the parent-child behaviors scored in accordance with the 3-bag task coding scales used in the NICHD Study of Early Child Care. The parent detachment scale is based on observations of the parent's awareness of, attention to, and engagement with the child. Behavioral indicators of detachment include being consistently inattentive, being inconsistently attentive, and/or interacting with the child in a perfunctory or indifferent manner. Scoring considers both the quantity of behavioral indicators observed and the quality or intensity of the behaviors. A score of 1 represents very low detachment and score of 7 indicates very high detachment. A lower score represents a more favorable outcome.
Measured: At follow-up in-person meeting (42-72 months after birth of child)
Mean Proportion Correct Score on Working Memory Span Performance
This task measures working memory. Working memory involves holding information in short-term storage and attending to one item (i.e., a house) while overcoming interference from the other (i.e., an animal or color). The task requires children to perform the operation of naming and holding in mind two pieces of information simultaneously and to activate one while overcoming interference occurring from the other. The task becomes more difficult as the number of houses increases. In the pretest phase, it is established that children can name both the colors and the animals in the task. Children then receive three 1-house trials, three 2-house trials, and three 3-house trials. There are 18 items. Individually, incorrect items receive a score of 0 and correct items receive a score of 1. Item scores are averaged and the total score on this activity is a proportion correct score of all items which ranges from 0 to 1.
Measured: At follow-up in-person meeting (42- 72 months after birth of child)
Mean Proportion Correct Score on Inhibitory Motor Control Performance
This task measures inhibitory motor control and is a standard go no-go task. Children are presented with a large green button on the screen that makes a "popping" sound when it is touched. Children are instructed to touch the button every time that they see an animal (the 'go' response) except when that animal is a pig (the 'no-go' response). No-go responses vary in difficulty depending on how many go responses preceded them. In the pretest phase, children are asked to identify all of the animals. During administration items, the task is presented in varying numbers of go trials prior to each no-go trial, including, in standard order, 1-go, 3-go, 3-go, 5-go, 1-go, 5-go, 7-go and 7-go. There are 40 items. Individually, incorrect items receive a score of 0 and correct items receive a score of 1. Item scores are averaged and the total score on this activity is a proportion correct score of all items ranging from 0 to 1.
Measured: At follow-up in-person meeting (42-72 months after birth of child)
Mean Proportion Correct Score on Attention Shifting Performance
This task measures attention shifting and requires children to use flexible thinking. For the initial trials in the task, children are presented with two pictures (animals, flowers, etc.) that are similar along a single dimension of color, shape, or size. Initially, the child is explicitly told how two of the pictures are the same in some way. Then, the child is presented with a third picture alongside the original two and asked to state how the new picture is similar to one of the original pictures. This task requires the child to shift his/her attention from the initial dimension of similarity to a new dimension of similarity. In the most difficult, items all of the pictures are presented at once and children are prompted to identify both dimensions of similarity. There are 30 items. Incorrect items receive a score of 0 and correct items receive a score of 1. Item scores are averaged and the total score on this activity is a proportion correct score of all items ranging from 0 to 1.
Measured: At follow-up in-person meeting (42-72 months after birth of child)
Mean Language Total Standard Score
The Receptive One-Word Picture Vocabulary Test, Fourth Edition (ROWPVT-4) is a norm-referenced assessment that tests an individual's ability to match a spoken word with an image of an object, action, or concept. The test targets the ability to understand the meaning of words spoken and name what is depicted on a test plate without context. Scores range from 55 - 145. This is a standardized language assessment based on a mean of 100 and a standard deviation of 15. Scores of 85-115 are considered to be within the average range of functioning. Scores above 115 are considered above average and scores below 85 are considered below average. Scores from this measure indicate that a child's receptive vocabulary is above average, below average, or equivalent to their peers of the same age.
Measured: At follow-up in-person meeting (42-72 months after birth of child)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start31 Mar 2017
- Primary completion4 Oct 2023
- Study completion4 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Chris Wimer, Columbia University
- Investigators
- Christopher Wimer, PhD, Principal investigator, Senior Research Scientist at CPRC, School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226053
- Sponsor's protocol ID
- AAAR1340
- Other IDs
- P2CHD058486
- Acronym
- RTG
- Status last verified
- May 2026
- First submitted
- 9 Jan 2020
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23302300Duncan 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.
PubMed 21688900Chaudry 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.
PubMed 27044698Duncan, G.J., Magnuson, K., Kalil, A. et al. Soc Indic Res (2012) 108: 87. https://doi.org/10.1007/s11205-011-9867-9
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.
PubMed 27044688Wimer 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.
PubMed 34149135
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Early Childhood Parenting Supports and Children's Health and Development
- ClinicalTrials.gov ID
- NCT04226053
- Acronym / sponsor ID
- RTG / AAAR1340
- Conditions
- Parenting, Child Development
- Keywords
- Poverty, Children, Social support, Practical support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 4 Oct 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Posted 22 May 2026
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Parenting, Child DevelopmentThe treatment group will consist of mothers who were randomly selected to receive Room to Grow services, which include three years of social and practical support for the mother and baby through a combination of one-on-one sessions with an expert clinical social worker in-person every three months and provision of essential baby items and equipment. |
| Control Group | No intervention | –The control group will consist of mothers who will not receive Room to Grow services. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- Must be at least 16 years old
- In third trimester (weeks 28-34) of pregnancy
- Meet Room to Grow program criteria
- Low-Income
Key exclusion criteria (5 listed)
- Cannot read/write English and/or Spanish
- Male
- Past third trimester
- Already given birth
- Mid to high income
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 |
|---|---|---|
| Parenting, Child DevelopmentThe treatment group will consist of mothers that were randomly selected to receive Room to Grow services, which include three years of social and practical support for the mother and baby. The research-informed program model combines tailored, one-on-one sessions with an expert clinical social worker in-person every three months, provision of essential baby items including books, toys, clothing, and equipment (retail value of in-kind items over three years averages $10,000), and connections to vital community resources (e.g., housing, entitlements, child care, social services). | Other | Intervention Group |
Primary outcome
Mean Score of Depressive Symptoms Using the CES-D Scale
Time frame: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
The Center for Epidemiological Studies-Depression (CES-D), is a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The Baseline and 25-month surveys included 12 items from the scale, and the 10.5-month survey included 7 items. The subscale scores range from 0 - 21 and 0 - 36, respectively. Higher scores indicate greater depressive symptoms.
Mean Score of Perceived Stress Scale (PSS)
Time frame: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
The Perceived Stress Scale (PSS) is a widely used instrument for measuring the perception of general stress. This 14-item scale measures how stressful or uncontrollable participants find their lives. Respondents rate the frequency of their feelings and thoughts related to events and situations that occurred in the last month. Individual scores on the PSS can range from 0-40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. The Baseline and 10.5-month surveys included 4 items from the scale. The 25-month survey included 6 items. Scores ranged from 0 - 16 and 0 - 24, respectively. Higher scores indicate higher perceived stress levels.
Mean Score of Parental Sense of Competence Using PSOC Scale
Time frame: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
The Parenting Sense of Competence Scale (PSOC). The PSOC measures parental competence on two dimensions: Satisfaction and Efficacy. It is a 17-item Likert-scale questionnaire (on a 6-point scale ranging from strongly agree [1] to strongly disagree [6]), with nine questions under Satisfaction and eight under Efficacy. Satisfaction section examines the parents' anxiety, motivation and frustration, while the Efficacy section looks at the parents' competence, capability levels, and problem-solving abilities in their parental role. Scores range from 17-102. A higher score indicates a higher parenting sense of competency. The Baseline and the 10.5-month surveys included 5 items from the scale with a modified 4-point scale ranging from strongly agree [1] to strongly disagree [4]. The 25-month survey included 8 items with the modified 4-point scale. Scores ranged from 4 - 20 and 4 - 32, respectively, with higher scores indicating a higher parenting sense of competency.
Mean Score of the Confusion, Hubbub, and Order Scale (CHAOS)
Time frame: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
The Confusion, Hubbub, and Order Scale (CHAOS) is a questionnaire filled out by parents that is designed to assess the level of confusion and disorganization in the child's home environment. The statements are scored using a 4-point scoring system. The questionnaire consists of 15 statements, to each of which a parent or caregiver responds (1) True, or (0) False (scoring was adjusted for items that required reverse coding). Scores ranged from 0-15. The Baseline and the 10.5-month surveys included 2 items from the scale with a modified 4-point scale ranging from 0 - 3: 0 = Not at all like your own home; 1 = A little bit like your own home; 2 = Somewhat like your own home; 3 = Very much like your own home. The 25-month survey included 5 items from the scale. Item scores were averaged and ranged from 0 - 3. A higher score represents characteristics of a more chaotic, disorganized, and hurried home.
Mean Score of Cognitive Stimulation in the Home (STIMQ)
Time frame: 10.5 months after birth of child; 25 months after birth of child
STIMQ is a measure of cognitive stimulation in the home consisting of 4 subscales: Availability of Learning Materials (ALM), Reading, Parental Involvement in Developmental Advance (PIDA), and Parental Verbal Responsivity (PVR). The 10-month \& 25-month surveys contained 4 of the 7 items in the PVR scale to measure cognitive stimulation. Respondents reported on the frequency of verbal responsiveness during everyday routines with their child. The full PVR scale uses an 8-point response scale ranging from 0 (never) - 7 (every day) and total scores range from 0 - 49 for preschool-age children. A modified 4-point response scale ranging from 1 (not at all) - 4 (every day). The average score of the four items was used and total scores ranged from 1-4. A higher score represents more responsivity and reflects greater stimulation in the home (a more favorable outcome).
Mean Score of Aggravation in Parenting Scale
Time frame: 10.5 months after birth of child; 25 months after birth of child
A measurement of stress experienced by parents associated with caring for children. It measures the amount of parenting stress brought on by changes in employment, income or other factors in the parent's life. Research has shown that high levels of aggravation in parenting are related to mothers' employment status and to child behavior problems. High stress and aggravation in parents are associated with poor cognitive and socioemotional development of young children. 6 of the 9 items in the scale were included in the surveys. Response categories being (0) Strongly agree, (1) Somewhat agree, (2) Somewhat disagree, (3) Strongly disagree. This 0-3 score is reverse coded, and items are averaged to create an overall score with higher scores indicating more stress. Total scores ranged from 0-3.
Number of Toys and Goods in the Home
Time frame: 10.5 months after birth of child; 25 months after birth of child
Subjects are asked if they have certain types of developmentally appropriate toys and games in the categories of symbolic play (doll, toy pots, small car), art (crayons, Play-Doh, paint), adaptive/fine motor toys (puzzle, shape sorter, pop-up toy), language (toy letters or numbers, toys that make animal sounds) and life-size toys (toy car or animal for child to ride). Respondents can answer yes/no for each (1=yes, 0=no). Subjects were asked about 13 items in the 10-month survey and 16 items in the 25-month survey. Items were replaced or supplemented for age-appropriateness at each wave. Item responses were tallied resulting in scores ranging from 0-13 and 0-16, respectively. A higher score or number of developmentally appropriate toys and goods in the home reflects a more favorable outcome for the child.
Worry Enough Money for Baby Scale Score
Time frame: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
Subjects are asked to rate (on a scale of 1-10) how worried they are about having enough money to cover their baby's expenses with 1 being "Not at all worried" and 10 being "Very worried". A lower score indicates less concern and is therefore favorable.
Mean Score of Parent Supportiveness Using the 3-bag Task
Time frame: At follow-up in-person meeting (42-72 months after birth of child)
The 3-bag task utilizes a semi-structured play protocol in which the parent-child dyad is instructed to play with the toys in each of three bags in a predetermined sequence. The semi-structured play interactions are videotaped and the parent-child behaviors scored in accordance with the 3-bag task coding scales used in the National Institute of Child Health and Human Development Study of Early Child Care. Parent supportiveness is the average of three measures: maternal sensitivity, positive affect, and the extent to which the parent provides cognitive stimulation while interacting with their child. Scoring for all three considers both the quantity and quality or intensity of behavioral indicators observed for each; a score of 1 represents virtually no evidence of the particular behavior and a score of 7 indicates very high levels of the behavior. As an average of the three, parent supportiveness follows the same scoring scheme and higher scores represent a more favorable outcome.
Mean Score of Parent Detachment Using 3 Bag-task
Time frame: At follow-up in-person meeting (42-72 months after birth of child)
The 3-bag task utilizes a semi-structured play protocol in which the parent-child dyad is instructed to play with the toys in each of three bags in a predetermined sequence. The semi-structured play interactions are videotaped and the parent-child behaviors scored in accordance with the 3-bag task coding scales used in the NICHD Study of Early Child Care. The parent detachment scale is based on observations of the parent's awareness of, attention to, and engagement with the child. Behavioral indicators of detachment include being consistently inattentive, being inconsistently attentive, and/or interacting with the child in a perfunctory or indifferent manner. Scoring considers both the quantity of behavioral indicators observed and the quality or intensity of the behaviors. A score of 1 represents very low detachment and score of 7 indicates very high detachment. A lower score represents a more favorable outcome.
Mean Proportion Correct Score on Working Memory Span Performance
Time frame: At follow-up in-person meeting (42- 72 months after birth of child)
This task measures working memory. Working memory involves holding information in short-term storage and attending to one item (i.e., a house) while overcoming interference from the other (i.e., an animal or color). The task requires children to perform the operation of naming and holding in mind two pieces of information simultaneously and to activate one while overcoming interference occurring from the other. The task becomes more difficult as the number of houses increases. In the pretest phase, it is established that children can name both the colors and the animals in the task. Children then receive three 1-house trials, three 2-house trials, and three 3-house trials. There are 18 items. Individually, incorrect items receive a score of 0 and correct items receive a score of 1. Item scores are averaged and the total score on this activity is a proportion correct score of all items which ranges from 0 to 1.
Mean Proportion Correct Score on Inhibitory Motor Control Performance
Time frame: At follow-up in-person meeting (42-72 months after birth of child)
This task measures inhibitory motor control and is a standard go no-go task. Children are presented with a large green button on the screen that makes a "popping" sound when it is touched. Children are instructed to touch the button every time that they see an animal (the 'go' response) except when that animal is a pig (the 'no-go' response). No-go responses vary in difficulty depending on how many go responses preceded them. In the pretest phase, children are asked to identify all of the animals. During administration items, the task is presented in varying numbers of go trials prior to each no-go trial, including, in standard order, 1-go, 3-go, 3-go, 5-go, 1-go, 5-go, 7-go and 7-go. There are 40 items. Individually, incorrect items receive a score of 0 and correct items receive a score of 1. Item scores are averaged and the total score on this activity is a proportion correct score of all items ranging from 0 to 1.
Mean Proportion Correct Score on Attention Shifting Performance
Time frame: At follow-up in-person meeting (42-72 months after birth of child)
This task measures attention shifting and requires children to use flexible thinking. For the initial trials in the task, children are presented with two pictures (animals, flowers, etc.) that are similar along a single dimension of color, shape, or size. Initially, the child is explicitly told how two of the pictures are the same in some way. Then, the child is presented with a third picture alongside the original two and asked to state how the new picture is similar to one of the original pictures. This task requires the child to shift his/her attention from the initial dimension of similarity to a new dimension of similarity. In the most difficult, items all of the pictures are presented at once and children are prompted to identify both dimensions of similarity. There are 30 items. Incorrect items receive a score of 0 and correct items receive a score of 1. Item scores are averaged and the total score on this activity is a proportion correct score of all items ranging from 0 to 1.
Mean Language Total Standard Score
Time frame: At follow-up in-person meeting (42-72 months after birth of child)
The Receptive One-Word Picture Vocabulary Test, Fourth Edition (ROWPVT-4) is a norm-referenced assessment that tests an individual's ability to match a spoken word with an image of an object, action, or concept. The test targets the ability to understand the meaning of words spoken and name what is depicted on a test plate without context. Scores range from 55 - 145. This is a standardized language assessment based on a mean of 100 and a standard deviation of 15. Scores of 85-115 are considered to be within the average range of functioning. Scores above 115 are considered above average and scores below 85 are considered below average. Scores from this measure indicate that a child's receptive vocabulary is above average, below average, or equivalent to their peers of the same age.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23302300Peacock 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.
- Background: PubMed 21688900Duncan 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.
- Background: PubMed 27044698Chaudry 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.
- BackgroundDuncan, G.J., Magnuson, K., Kalil, A. et al. Soc Indic Res (2012) 108: 87. https://doi.org/10.1007/s11205-011-9867-9
- Background: PubMed 27044688Cates 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.
- Results publication: PubMed 34149135Wimer 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.
- Individual participant dataSharing planned: No
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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.
Christopher Wimer, PhD principal investigator
Senior Research Scientist at CPRC, School of Social Work
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting, Child Development in people with Parenting and Child Development, run by Columbia University at 1 site 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 6 inclusion and 5 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Score of Depressive Symptoms Using the CES-D Scale (time frame: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child). The study lists 14 primary outcomes in all. 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 NCT04226053, which also lists 6 linked publications.
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 22 May 2026.