Virtual Mentorship to Support Maternal and Infant Health and Wellbeing: Assessing the Impact and Efficacy of NurturePA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Parental Stress
研究概览
简要总结
The primary objective of this study is to determine whether the NurturePA text-based mentorship program reduces maternal stress and depressive symptoms, increases maternal knowledge, and increases engagement in language and literacy practices among new mothers relative to the control condition of periodic informational texts at the four-month data collection point.
详细描述
Context: New parents in the US are typically offered little if any support with the transition to parenthood, despite the difficulty many families experience during this time and the importance of positive early parent-child interactions to children's future school and life outcomes.
Objectives: This study seeks to evaluate the impact of the NurturePA text-based mentorship program on maternal and infant health and wellbeing.
Study Design: Randomized control trial Setting/Participants: Participants will be recruited from the West Penn Hospital Maternity Ward. 200 participants (100 treatment, 100 control) will be recruited. They must be first or second time mothers of a focal infant of full term gestational age and normal birthweight. They must be current residents of Allegheny County and plan to remain in Allegheny County for the next two years.
Study Interventions and Measures: Treatment participants will be enrolled in the NurturePA text-based mentorship program and assigned a mentor with whom they can communicate. Control participants will receive periodic texts from NurturePA with information about child safety and health.
This study will measure maternal mood and stress, engagement in parent-child language and literacy activities, maternal knowledge, and child developmental outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Resident of Allegheny County
- •First time mother or mother of one other child
- •Gestational age of focal infant at birth is at or above 34 weeks
- •Birthweight of focal infant at or above 4 pounds (1814 grams)
- •Focal infant leaving hospital with mother (e.g. no extended NICU stay)
- •Planning to remain living in Allegheny County for at least two years
- •No more than one other child living full time and being cared for in the home (including non-biological children)
排除标准
- •History of substance abuse disorder
- •Parents/guardians who, in the opinion of the Investigator, may be non-adherent with study schedules or procedures.
结局指标
主要结局
Parental Stress
时间窗: 4 months from study start
We will measure parental stress using self-administered subscales from the parent domain of the Parenting Stress Index (4th Edition): isolation, attachment, depression, child reinforces parent, and parent competence (15 minutes; Abidin, 2012). As we are omitting subscales that are not of interest, we cannot generate an overall score. Each subscale can be scored individually. Each subscale has a number of items scored 1 (strongly disagree) to 5 (strongly agree). The number of items per subscale and therefore the subscale score ranges vary. The ranges for each subscale are as follows: isolation (6-30), attachment (7-35), depression (9-45), child reinforces parent (6-30), and parent competence (11-55). Subscale scores are calculated by summing each of the responses that correspond with the subscale. Higher scores indicate higher levels of stress, which is considered to be a worse outcome. Percentile scores corresponding to each of the subscale raw scores are also available.
Parental stress
时间窗: 18 months from study start
We will measure parental stress at 18 months from study start using two of three self-administered subscales of the Parenting Stress Index Short Form (Fourth Edition): parental distress and parent-child dysfunctional interaction (10 minutes; Abidin, 2012). We will be reporting individual measurements, rather than change over time. As we are omitting subscales that are not of interest to our project, we cannot generate an overall score for the parent domain. However, each subscale can be scored individually. Each subscale has a number of items scored 1 (strongly disagree) to 5 (strongly agree). Each subscale has 12 items and thus score ranges of 12-60. Subscale scores are calculated by summing each of the responses that correspond with the subscale. Higher scores indicate higher levels of stress, which is considered to be a worse outcome. Percentile scores corresponding to each of the subscale raw scores are also available.
次要结局
- Maternal Knowledge(4 months from study start)
- Engagement in Language and Literacy Activities(18 months from study start)
- Child Development(18 months from study start)
- WIC Usage(4 and 18 months from study start)
- Edinburgh Postnatal Depression Scale(4 months from start of the study)
- Early Language and Development Screening(4 and 18 months from study start)
研究者
Lindsay Page
Assistant Professor
University of Pittsburgh