Trial Outcomes & Findings for Room to Grow Evaluation for Children (NCT NCT04226053)

Participants were recruited based on referrals shared with the Room to Grow program from hospital staff and non-profit agencies across New York City (NYC). Participants that agreed to study participation and scheduled their baseline appointment were randomized to either the treatment or control group. The first participant was enrolled in March 2017 and the last participant was enrolled in July 2018.

320 participants were enrolled and randomized to treatment. Children born during the study were not considered enrolled, however, they did contribute to assessments in the final study period.

Room to Grow Evaluation for Children

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.