Evaluación de espacio para crecer para niños (RTG)
Apoyo integral para la crianza de los hijos en la primera infancia y salud y desarrollo de los niños
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
El objetivo del programa innovador de RtG es ayudar a los padres a aumentar la probabilidad de que sus hijos ingresen a la escuela listos para aprender y continúen alcanzando su máximo potencial en educación, trabajo y ciudadanía. El enfoque terapéutico, psicodinámico y la sólida relación de tres años con las familias está diseñado para actuar como catalizador para un cambio sostenible a largo plazo en los métodos de crianza y la estabilidad del sistema familiar. De manera crítica, y en contraste con otros programas destinados a mejorar la crianza y el desarrollo infantil, RtG cree que brindar asistencia material concreta mejora la efectividad del asesoramiento y las referencias a familias de bajos ingresos al reducir el estrés económico y liberar recursos escasos. El programa se basa en décadas de investigación sobre la importancia del apoyo a los padres para las familias de bajos ingresos y sus hijos, la importancia del apoyo material concreto y la reducción de la pobreza para mejorar la salud y el desarrollo de los niños, y el reconocimiento de que los primeros años son un momento eficaz para proporcionar apoyos críticos que influyan en los resultados a largo plazo. Numerosos programas, como los modelos de visitas domiciliarias que brindan apoyo para la crianza a las nuevas madres de bajos ingresos, han mostrado resultados prometedores. Después de décadas de investigación correlacional que establece relaciones entre los ingresos, la pobreza y la salud y el desarrollo de los niños, existe una literatura emergente que brinda evidencia causal convincente de que los ingresos son importantes para los resultados de los niños. Ambas líneas de esta investigación se basan en investigaciones adicionales que sugieren claramente que la primera infancia es un período clave de vulnerabilidad en el que las intervenciones pueden marcar una diferencia duradera en la suerte de los niños de bajos ingresos y sus familias. La investigación se basará en esta literatura, probando una intervención que combina apoyos para los padres y la provisión significativa de apoyo material; en esencia, evaluando si un enfoque combinado puede resultar potencialmente más poderoso que la suma de sus partes.
La evaluación de RtG brinda la oportunidad sin precedentes de probar el valor combinado de la educación para padres con apoyo social y material. El proyecto aprovecha un enfoque innovador que combina apoyos de ingresos, educación para padres y conexión con servicios comunitarios para promover la salud temprana y el desarrollo de los niños pequeños. Tanto los programas de crianza como los de apoyo a los ingresos tienen como objetivo promover la salud y el desarrollo positivos de las familias de ingresos bajos y moderados, pero con demasiada frecuencia funcionan de forma aislada, lo que puede limitar su capacidad para reducir las disparidades en la salud y el desarrollo de los padres y los niños. El modelo innovador de RtG brinda la oportunidad de probar el efecto combinado de estos servicios y brinda información valiosa a los profesionales y los responsables de la formulación de políticas sobre los efectos sinérgicos de estos componentes del programa. La investigación propuesta puede facilitar el cambio en el campo de la primera infancia al demostrar evidencia preliminar de que este modelo innovador puede lograr efectos demostrables en los resultados proximales clave durante el primer año de vida y proporcionar un primer paso hacia la construcción de evidencia para enfoques múltiples para cumplir con los objetivos. necesidades de las familias de escasos recursos. Los hallazgos de este estudio pueden guiar el campo hacia enfoques más integrados que combinen apoyo material, conexión a recursos y asistencia para padres para lograr un impacto real en la salud y el desarrollo de los niños pequeños. Room to Grow y su evaluación proporcionarán contribuciones claras al desarrollo de una cultura de salud y políticas relevantes en el espacio de la primera infancia. Este será el primer RCT que proporcione una combinación de apoyo para los padres y la comunidad con una provisión sustancial y empoderadora de apoyo material. Muchos programas para padres proporcionan algunos libros o juguetes apropiados para el desarrollo, pero es increíblemente raro proporcionar el equivalente minorista de aproximadamente $ 10,000 en apoyo durante los primeros tres años de vida. Esto establecerá si un modelo como el de RtG es prometedor para transformar los programas de crianza de los hijos en la primera infancia para ayudar a construir una cultura de la salud y reducir las disparidades de salud entre los niños de diferentes orígenes. La organización y su liderazgo esperan aprender del proyecto de evaluación para comprender más acerca de lo que funciona bien y lo que podría mejorarse en la ejecución del programa y el currículo. El equipo de RtG ha creado a propósito una cultura que utiliza datos para informar la toma de decisiones y espera comprender el alcance completo de los resultados del RCT. RtG actualmente está desarrollando planes de expansión para los próximos cinco años como parte de un proceso de planificación estratégica formal. La organización espera eventualmente servir al doble o más del número de familias en cada ciudad donde opera, Nueva York y Boston. Los hallazgos hasta la fecha de las evaluaciones internas son extremadamente alentadores. Los investigadores esperan que otras fundaciones y agencias gubernamentales (o donantes privados) se animen a aprovechar el apoyo de la Fundación Robert Wood Johnson y que los investigadores puedan extender el impulso inicial generado por este proyecto a lo largo del tiempo.
El proyecto está diseñado para investigar resultados próximos. A largo plazo, el equipo de investigación espera aprovechar estos resultados proximales y eventualmente seguir a los niños hasta la edad escolar, así como expandir en gran medida la cantidad de niños incluidos en el proyecto RCT.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University - Columbia Population Research Center (CPRC)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Descripción
Criterios de inclusión:
- Femenino
- Debe tener al menos 16 años
- En el tercer trimestre (semanas 28-34) de embarazo
- Cumplir con los criterios del programa Room to Grow
- De bajos ingresos
- En necesidad de servicios
Criterio de exclusión:
- No puede leer/escribir inglés y/o español
- Masculino
- Pasado el tercer trimestre
- Ya dio a luz
- Ingresos medios a altos
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervention Group
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.
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El grupo de tratamiento estará compuesto por madres que fueron seleccionadas al azar para recibir los servicios Room to Grow, que incluyen tres años de apoyo social y práctico para la madre y el bebé.
El modelo de programa basado en investigaciones combina sesiones individuales personalizadas con un trabajador social clínico experto en persona cada tres meses, provisión de artículos esenciales para bebés, incluidos libros, juguetes, ropa y equipo (valor minorista de artículos en especie durante tres años promedia $10,000) y conexiones a recursos vitales de la comunidad (por ejemplo, vivienda, derechos, cuidado infantil, servicios sociales).
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Sin intervención: Control Group
The control group will consist of mothers who will not receive Room to Grow services.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean Score of Depressive Symptoms Using the CES-D Scale
Periodo de tiempo: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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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. |
At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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Mean Score of Perceived Stress Scale (PSS)
Periodo de tiempo: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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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. |
At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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Mean Score of Parental Sense of Competence Using PSOC Scale
Periodo de tiempo: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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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. |
At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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Mean Score of the Confusion, Hubbub, and Order Scale (CHAOS)
Periodo de tiempo: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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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. |
At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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Mean Score of Cognitive Stimulation in the Home (STIMQ)
Periodo de tiempo: 10.5 months after birth of child; 25 months after birth of child
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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). |
10.5 months after birth of child; 25 months after birth of child
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Mean Score of Aggravation in Parenting Scale
Periodo de tiempo: 10.5 months after birth of child; 25 months after birth of child
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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.
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10.5 months after birth of child; 25 months after birth of child
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Number of Toys and Goods in the Home
Periodo de tiempo: 10.5 months after birth of child; 25 months after birth of child
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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.
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10.5 months after birth of child; 25 months after birth of child
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Worry Enough Money for Baby Scale Score
Periodo de tiempo: At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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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.
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At Baseline (weeks 28-34 of pregnancy); 10.5 months after birth of child; 25 months after birth of child
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Mean Score of Parent Supportiveness Using the 3-bag Task
Periodo de tiempo: At follow-up in-person meeting (42-72 months after birth of child)
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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.
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At follow-up in-person meeting (42-72 months after birth of child)
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Mean Score of Parent Detachment Using 3 Bag-task
Periodo de tiempo: At follow-up in-person meeting (42-72 months after birth of child)
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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.
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At follow-up in-person meeting (42-72 months after birth of child)
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Mean Proportion Correct Score on Working Memory Span Performance
Periodo de tiempo: At follow-up in-person meeting (42- 72 months after birth of child)
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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.
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At follow-up in-person meeting (42- 72 months after birth of child)
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Mean Proportion Correct Score on Inhibitory Motor Control Performance
Periodo de tiempo: At follow-up in-person meeting (42-72 months after birth of child)
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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.
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At follow-up in-person meeting (42-72 months after birth of child)
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Mean Proportion Correct Score on Attention Shifting Performance
Periodo de tiempo: At follow-up in-person meeting (42-72 months after birth of child)
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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.
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At follow-up in-person meeting (42-72 months after birth of child)
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Mean Language Total Standard Score
Periodo de tiempo: At follow-up in-person meeting (42-72 months after birth of child)
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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.
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At follow-up in-person meeting (42-72 months after birth of child)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Christopher Wimer, PhD, Senior Research Scientist at CPRC, School of Social Work
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- Duncan, 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AAAR1340
- P2CHD058486 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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