TMW Center for Early Learning + Public Health Community-Wide Demonstration Project
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 8
- 主要终点
- Parental Cognition and Conduct Toward the Infant Scale (PACOTIS)
研究概览
简要总结
The TMW Center is launching a community-wide demonstration project in partnership with the Children's Services Council of Palm Beach County, Florida, in which the TMW interventions will be delivered at scale through partners who work with families across health, education, and social service systems. The goal of this partnership is to reach 60% of all families with children age birth through three with at least one TMW intervention over the five-year partnership, with a significant percentage of families receiving more than one intervention. The TMW Center will evaluate the efficacy of the multiple intervention approach in impacting parent knowledge, beliefs, and behavior and child developmental outcomes, and develop an implementation model that can be used in other communities.
详细描述
The treatment community will consist of all participants enrolled in one or more of the 3Ts Interventions (3Ts-Newborn, 3Ts-Well Baby, 3Ts-Let's Talk!) The 3Ts interventions, the educational curricula designed by the TMW Center) were named for the three easy to use strategies that are shared with parents to support their child's development: Tune In, Talk More, and Take Turns.
To compare outcomes and evaluate effectiveness of the interventions, a comparison community will be selected beginning in 2021. To define the sample of comparison families, the TMW Center and CSC will work to find a comparison hospital with similar socioeconomic characteristics and child developmental outcomes as the treated community. Then within this comparison group, the researchers will define a sample of comparison families who have similar individual characteristics as the treated families (based on data shared by CSC and baseline data the researchers will collect). They will complete the same surveys as the treatment community but will not be offered the interventions.
The following describes the ideal progression through the full intervention and study timeline. However, participants are able to join during any intervention time point (e.g. 3Ts-Newborn, or the third 3Ts-Well Baby video time point, etc), even if they have not completed previous study measures. Whenever a participant engages 3Ts interventions for the first time, they will complete the eConsent module prior to receiving any intervention content. They will complete only the surveys applicable to the time point of their enrollment and beyond, according to the study timeline. Similarly, if they choose to skip certain interventions or survey time points, they will still be able to complete the later time points. The researchers will not ask participants to complete any missed intervention or survey time points or require them to complete any skipped interventions or surveys. Participants selected in the comparison group will complete only the activities here labeled 'Data Collection.'
Data collection: Baseline These measures will be collected at the parent's first interaction with the TMW study, regardless of intervention time point. Following the eConsent, participants will be asked to provide contact information and basic demographic information (parent name, parent DOB, child DOB). Then participants will be asked to fill out one survey, the Survey of Parental Expectations and Knowledge about Language Learning (SPEAK) that assess their knowledge and beliefs of child language and cognitive development. The version of the SPEAK to be used will depend on the child's age and at which intervention they are completing the baseline measures. If the participant's baseline is at the 3Ts-Newborn Intervention, the parent will complete SPEAK-20. If done at the start of the 3Ts-Well Baby Intervention, participants will complete the Baby SPEAK-10. eConsent and surveys will be collected digitally through the secure online platform.
Intervention 1: 3Ts-Newborn This intervention is completed with parents of newborns in the postpartum mother-baby unit in the hospital. Participants will complete the 3Ts-Newborn educational intervention as part of Florida's Universal Infant Screen. After completing the eConsent module and filling out the demographics survey, parents will complete the SPEAK-20 survey using the tablet. After this, they will watch the 12 minute education intervention video, also on the tablet. Finally, parents will complete the Baby SPEAK-10 survey using the tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be able to understand English or Spanish
- •Must be the parent/caregiver of a child in the target range of the intervention (at birth for the 3Ts-Newborn, 0-6 months for 3Ts-Well Baby and 0-3 years for 3Ts-Let's Talk!). For this study, the parent is defined as person with custody of the child.
排除标准
- •Parents under the age of 18 who are not emancipated minors
- •Parents who do not have legal custody of their child
- •Parents who do not speak enough English or Spanish to receive their educational information in that language.
结局指标
主要结局
Parental Cognition and Conduct Toward the Infant Scale (PACOTIS)
时间窗: Up to 3-years of age
A self-report measure of the respondent's perceived impact on their child's development. Scores for each of the 5 items range from 0 ('Not at all what I think') to 10 ('Exactly what I think'). A lower score indicates a better outcome
MacArthur-Bates Communicative Development Inventories-Short Form (MCDI-SF)
时间窗: Up to 3-years of age
Parent report measure of words that their child understands and says. For a list of words, a parent marks whether a child 'understands', 'understands and says' or 'neither understands nor says.' Each column is tallied and higher counts in the 'understands and says' column indicate better outcomes
StimQ - Reading Subscale
时间窗: Up to 3-years of age
A questionnaire that is designed to explore the different kinds of activities that primary caregivers engage in with their infant child, preschool child, or toddler and their role in promoting cognitive stimulation for the child. Items 1-4 are scored on a scale of 0-4 based on how often a parent engages in certain behaviors. Items 5-10 are scored as a Yes (1 point) or No (0 points). A higher score indicates a better outcome
Survey of Parental Expectations and Knowledge (SPEAK)
时间窗: Up to 3-years of age
Measures parental knowledge and expectations of how their children learn language at different ages. Some items about beliefs of appropriate age of exposure are rated on a 6-point scale ranging from: 1 "As an infant (0 to 6 moths)" to 6 "In elementary school (6 years and up)" Other items are rated on a 4-point Likert scale ranging from 1 (definitely true), 2 (probably true), 3 (probably not true) to 4 (definitely not true). Scores range from 0 to 71, and scoring of each item is based a criterion scale, with 0 points given to the most incorrect response and 1 additional point given to each progressively more correct response. A higher score correlates to a better outcome and indicates a higher parental knowledge.
次要结局
未报告次要终点
