- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04226053
성장의 여지 어린이를 위한 평가 (RTG)
포괄적인 조기 아동 양육 지원 및 아동의 건강 및 발달
연구 개요
상세 설명
RtG의 혁신적인 프로그램의 목표는 부모가 자녀가 학습할 준비가 된 학교에 입학하고 교육, 직업 및 시민권에서 잠재력을 최대한 발휘할 수 있는 가능성을 높이는 것입니다. 치료적, 정신역동적 접근과 가족과의 견고한 3년 간의 관계는 양육 방법과 가족 시스템의 안정성에서 지속 가능하고 장기적인 변화를 위한 촉매 역할을 하도록 설계되었습니다. 비판적으로, 그리고 양육 및 아동 발달 개선을 목표로 하는 다른 프로그램과 달리 RtG는 구체적인 물질적 지원을 제공하는 것이 경제적 스트레스를 줄이고 부족한 자원을 확보함으로써 저소득 가정에 대한 상담 및 추천의 효과를 향상시킨다고 믿습니다. 이 프로그램은 저소득 가정과 그 자녀를 위한 양육 지원의 중요성, 자녀의 건강과 발달을 강화하는 데 있어 구체적인 물질적 지원과 빈곤 감소의 중요성, 유아기가 자녀 양육에 효과적인 시기라는 인식에 대한 수십 년간의 연구를 기반으로 합니다. 장기적인 결과에 영향을 미치는 중요한 지원을 제공합니다. 저소득 산모에게 육아를 지원하는 가정방문모델 등 다양한 프로그램이 좋은 성과를 내고 있다. 소득, 빈곤, 아동의 건강과 발달 사이의 관계를 확립한 수십 년간의 상관관계 연구 끝에 소득이 아동 결과에 중요하다는 설득력 있는 인과적 증거를 제공하는 새로운 문헌이 등장했습니다. 이 연구의 두 계통은 초기 아동기가 저소득 아동과 그 가족의 재산에 지속적인 변화를 가져올 수 있는 취약성의 핵심 기간임을 분명히 시사하는 추가 연구를 기반으로 합니다. 이 연구는 육아 지원과 물질적 지원의 의미 있는 제공을 결합하는 중재를 테스트함으로써 이 문헌을 기반으로 할 것입니다.
RtG의 평가는 양육 교육과 사회적 및 물질적 지원의 결합된 가치를 테스트할 수 있는 전례 없는 기회를 제공합니다. 이 프로젝트는 어린 아이들의 초기 건강과 발달을 촉진하기 위해 소득 지원, 육아 교육 및 지역 사회 서비스와의 연결을 결합하는 혁신적인 접근 방식을 활용합니다. 양육 및 소득 지원 프로그램은 각각 저소득 및 중산층 가족의 긍정적인 건강 및 발달을 촉진하는 것을 목표로 하지만 너무 자주 고립되어 작동하여 부모와 자녀의 건강 및 발달의 불균형을 줄이는 능력을 잠재적으로 제한합니다. RtG의 혁신적인 모델은 이러한 서비스의 결합 효과를 테스트할 수 있는 기회를 제공하고 이러한 프로그램 구성 요소의 시너지 효과에 대해 실무자와 정책 입안자에게 귀중한 정보를 제공합니다. 제안된 연구는 이 혁신적인 모델이 생후 1년 동안 주요 근접 결과에 대한 입증 가능한 효과를 달성할 수 있다는 예비 증거를 보여줌으로써 초기 아동기 분야의 변화를 촉진할 수 있으며 저소득 가정의 필요. 이 연구의 결과는 어린 아이들의 건강과 발달에 실질적인 영향을 미치기 위해 물질적 지원, 자원에 대한 연결 및 양육 지원을 결합하는 보다 통합된 접근 방식으로 현장을 안내할 수 있습니다. Room to Grow와 그에 대한 평가는 유아기 공간에서 건강 문화 및 관련 정책 개발에 분명한 기여를 할 것입니다. 이것은 물질적 지원의 실질적이고 힘을 실어주는 제공과 함께 육아 및 지역사회 지원의 조합을 제공하는 최초의 RCT가 될 것입니다. 많은 양육 프로그램은 발달에 적합한 책이나 장난감을 제공하지만, 생후 첫 3년 동안 대략 $10,000에 해당하는 소매 지원을 제공하는 것은 매우 드뭅니다. 이를 통해 RtG와 같은 모델이 다양한 배경을 가진 어린이들 사이의 건강 격차를 줄이고 건강 문화를 구축하는 데 도움이 되는 초기 아동 양육 프로그램을 변화시킬 수 있는지 여부를 확인할 수 있습니다. 조직과 경영진은 프로그램 제공 및 커리큘럼에서 무엇이 잘 작동하고 개선될 수 있는지에 대해 더 많이 이해하기 위해 평가 프로젝트에서 배우기를 기대합니다. RtG 팀은 의도적으로 데이터를 사용하여 의사 결정을 알리는 문화를 만들었으며 RCT 결과의 전체 범위를 이해하기를 기대합니다. RtG는 현재 공식 전략 계획 프로세스의 일환으로 향후 5년에 걸친 확장 계획을 개발하고 있습니다. 조직은 궁극적으로 조직이 운영되는 각 도시인 뉴욕과 보스턴에서 두 배 이상의 가족에게 서비스를 제공하기를 희망합니다. 현재까지의 내부 평가 결과는 매우 고무적입니다. 다른 재단과 정부 기관(또는 민간 기부자)이 로버트 우드 존슨 재단의 지원을 기반으로 구축하고 연구원들이 시간이 지남에 따라 이 프로젝트에서 생성된 초기 모멘텀을 확장할 수 있기를 바라는 것이 연구원들의 희망입니다.
이 프로젝트는 근접 결과를 조사하도록 설계되었습니다. 장기적으로 연구팀은 이러한 근접 결과를 바탕으로 궁극적으로 학령기까지 아동을 추적하고 RCT 프로젝트에 포함되는 아동의 수를 크게 확장하기를 희망합니다.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10032
- Columbia University - Columbia Population Research Center (CPRC)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 여성
- 16세 이상이어야 합니다.
- 임신 3분기(28~34주)
- Room to Grow 프로그램 기준 충족
- 저소득
- 서비스가 필요함
제외 기준:
- 영어 및/또는 스페인어를 읽고 쓸 수 없음
- 남성
- 지난 3분기
- 이미 출산
- 중상위 소득
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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치료 그룹은 엄마와 아기를 위한 3년간의 사회적 및 실질적 지원을 포함하는 Room to Grow 서비스를 받기 위해 무작위로 선택된 엄마들로 구성됩니다.
연구 정보 프로그램 모델은 3개월마다 전문 임상 사회 복지사와의 맞춤형 일대일 세션을 결합하여 책, 장난감, 의류 및 장비를 포함한 필수 아기 용품 제공(현물 품목의 소매가) 3년 동안 평균 $10,000), 중요한 지역 사회 자원(예: 주택, 자격, 보육, 사회 복지 서비스)에 대한 연결.
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간섭 없음: Control Group
The control group will consist of mothers who will not receive Room to Grow services.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean Score of Depressive Symptoms Using the CES-D Scale
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Christopher Wimer, PhD, Senior Research Scientist at CPRC, School of Social Work
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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