儿童成长空间评价 (RTG)
全面的幼儿育儿支持和儿童健康与发展
研究概览
详细说明
RtG 创新计划的目标是帮助家长提高孩子进入学校学习并继续发挥其在教育、工作和公民身份方面的全部潜力的可能性。 治疗性的心理动力学方法以及与家庭长达三年的稳固关系旨在成为养育方式和家庭系统稳定性的可持续、长期变化的催化剂。 至关重要的是,与旨在改善育儿和儿童发展的其他计划相比,RtG 认为,提供具体的物质援助可以通过减轻经济压力和释放稀缺资源来提高对低收入家庭的咨询和转介的有效性。 该计划建立在数十年的研究基础上,这些研究涉及为低收入家庭及其子女提供育儿支持的重要性、具体的物质支持和减贫对促进儿童健康和发展的重要性,以及人们认识到早年是培养孩子的有效时间。提供影响长期结果的关键支持。 许多项目,例如为低收入新妈妈提供育儿支持的家访模式,已经显示出可喜的成果。 经过数十年建立收入、贫困与儿童健康和发展之间关系的相关研究,新出现的文献提供了令人信服的因果证据,证明收入对儿童的结果很重要。 这两项研究都建立在其他研究的基础上,这些研究清楚地表明,幼儿期是一个脆弱的关键时期,干预措施可以对低收入儿童及其家庭的命运产生持久的影响。 该研究将建立在这些文献的基础上,通过测试结合了育儿支持和有意义的物质支持提供的干预措施 - 本质上,评估组合方法是否可以证明比其各部分的总和更有效。
RtG 的评估提供了前所未有的机会来测试亲子教育与社会和物质支持的综合价值。 该项目利用创新方法,将收入支持、育儿教育和与社区服务的联系结合起来,以促进幼儿的早期健康和发展。 育儿和收入支持计划均旨在促进中低收入家庭的积极健康和发展,但它们往往孤立运作,可能会限制它们减少父母和儿童健康和发展差距的能力。 RtG 的创新模型提供了一个机会来测试这些服务的综合效果,并为从业者和政策制定者提供有关这些计划组成部分的协同效应的宝贵信息。 拟议的研究可以通过展示初步证据证明这种创新模型可以在生命的第一年对关键的近端结果产生可证明的影响来促进幼儿领域的变革,并为建立多管齐下的方法来满足低收入家庭的需要。 这项研究的结果可能会指导该领域采用更综合的方法,将物质支持、资源联系和育儿援助结合起来,对幼儿的健康和发展产生真正的影响。 Room to Grow 及其评估将为早期儿童领域健康文化和相关政策的发展做出明确贡献。 这将是第一个将育儿和社区支持与大量和授权的物质支持相结合的随机对照试验。 许多育儿计划提供一些适合发育的书籍或玩具,但在生命的前三年提供相当于零售价大约 10,000 美元的支持的情况非常罕见。 这将确定像 RtG 这样的模型是否有望改变早期儿童育儿计划,以帮助建立健康文化并减少来自不同背景的儿童之间的健康差异。 该组织及其领导层期待从评估项目中学习,以便更多地了解项目交付和课程中哪些方面运作良好以及哪些方面可以改进。 RtG 的团队有目的地创造了一种使用数据为决策提供信息的文化,并期待了解 RCT 结果的全部范围。 作为正式战略规划流程的一部分,RtG 目前正在制定未来五年的扩张计划。 该组织希望最终能够在其开展业务的每个城市(纽约和波士顿)为双倍或更多的家庭提供服务。 迄今为止,内部评估的结果非常令人鼓舞。 研究人员希望其他基金会和政府机构(或私人捐助者)会很高兴在罗伯特伍德约翰逊基金会的支持下继续发展,并且研究人员将能够随着时间的推移扩大该项目产生的初始势头。
该项目旨在调查近端结果。 从长远来看,研究团队希望在这些近期结果的基础上进一步发展,并最终追踪到学龄期的儿童,并大大增加纳入 RCT 项目的儿童人数。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
New York
-
New York、New York、美国、10032
- Columbia University - Columbia Population Research Center (CPRC)
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 女性
- 必须年满 16 岁
- 妊娠晚期(第 28-34 周)
- 满足成长空间计划标准
- 低收入
- 需要服务
排除标准:
- 不能读/写英语和/或西班牙语
- 男性
- 过去的第三个三个月
- 已经生了
- 中高收入
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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.
|
治疗组将由随机选择接受成长空间服务的母亲组成,其中包括为母亲和婴儿提供三年的社会和实践支持。
以研究为依据的计划模式结合了量身定制的一对一会议,每三个月与一位专业的临床社会工作者面对面,提供基本的婴儿用品,包括书籍、玩具、衣服和设备(实物物品的零售价值三年平均 10,000 美元),以及与重要社区资源(例如住房、福利、儿童保育、社会服务)的联系。
|
|
无干预:Control Group
The control group will consist of mothers who will not receive Room to Grow services.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Score of Depressive Symptoms Using the CES-D Scale
大体时间: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. |
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)
大体时间: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. |
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
大体时间: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. |
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)
大体时间: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. |
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)
大体时间: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). |
10.5 months after birth of child; 25 months after birth of child
|
|
Mean Score of Aggravation in Parenting Scale
大体时间: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.
|
10.5 months after birth of child; 25 months after birth of child
|
|
Number of Toys and Goods in the Home
大体时间: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.
|
10.5 months after birth of child; 25 months after birth of child
|
|
Worry Enough Money for Baby Scale Score
大体时间: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.
|
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
大体时间: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.
|
At follow-up in-person meeting (42-72 months after birth of child)
|
|
Mean Score of Parent Detachment Using 3 Bag-task
大体时间: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.
|
At follow-up in-person meeting (42-72 months after birth of child)
|
|
Mean Proportion Correct Score on Working Memory Span Performance
大体时间: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.
|
At follow-up in-person meeting (42- 72 months after birth of child)
|
|
Mean Proportion Correct Score on Inhibitory Motor Control Performance
大体时间: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.
|
At follow-up in-person meeting (42-72 months after birth of child)
|
|
Mean Proportion Correct Score on Attention Shifting Performance
大体时间: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.
|
At follow-up in-person meeting (42-72 months after birth of child)
|
|
Mean Language Total Standard Score
大体时间: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.
|
At follow-up in-person meeting (42-72 months after birth of child)
|
合作者和调查者
调查人员
- 首席研究员:Christopher Wimer, PhD、Senior Research Scientist at CPRC, School of Social Work
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.