Purposeful Parenting: Enhanced Anticipatory Guidance for the First Year of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Responsive Parenting
研究概览
简要总结
Pediatricians' provision of parenting-focused anticipatory guidance often does not meet parents' needs; the few studies that have investigated primary-care based strategies to promote positive parenting rely on time-intensive, high-cost interventions, thereby limiting their generalizability. Therefore, the Purposeful Parenting was developed as a universal program of enhanced anticipatory guidance. At each well-child visit in the first year of a child's life, Purposeful Parenting provides parents with: 1) scripted anticipatory guidance and handouts focused on the child's emerging social-emotional and linguistic (SEL) skills, brain development and the importance of responsive parenting; and 2) a "reminder" item (e.g., a "Smile at Me" onesie) that allows for in-office role modeling and promotes practicing of an age-specific, nurturing parent-child interaction. If an in-office intervention is missed (e.g. parent cancels visit, interventionist out sick) the intervention will be delivered by telephone if possible by the site-based clinical interventionists and the "reminder" items will be mailed.
详细描述
The investigators will conduct a two-phase study. Phase I (months 1-4) will entail a brief pilot of Purposeful Parenting in three Boston-based health centers to optimize quality and logistical details. Phase II (months 5-36) will determine, with a parallel group randomized controlled trial (RCT), whether delivering Purposeful Parenting leads to increased responsive parenting at the intervention's conclusion (in intervention vs control parents), assessed using a validated observational measure. The investigators will enroll 260 low-income families with a full term newborn infant who present for well-child care. Families randomized to the control group will receive usual anticipatory guidance at each well-child visit in the first 12 months of life. Families randomized to the intervention group will receive usual anticipatory guidance plus Purposeful Parenting. As secondary outcomes, the investigators will explore the degree to which Purposeful Parenting (in intervention vs control parents) increases parental knowledge about responsive parenting and child development, reduces parenting stress and improves perceptions of parenting self-efficacy (via validated parental self-report measures) at the conclusion of the intervention. Investigators will explore potential differences by study group in child SEL development at the conclusion of the intervention. In addition, investigators will examine differences in the above listed outcomes are 6 months following the intervention. The RCT will include the collection of process level data including cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Families (parent >=18 years of age) with a newborn, born at >= 34 weeks, presenting for well-child care
- •Family plans to remain at that practice
- •English or Spanish speaking
排除标准
- •Debilitating chronic condition; prematurity (<34 weeks gestation)
研究组 & 干预措施
Purposeful Parenting
Families randomized to the intervention group will receive their pediatric provider's usual anticipatory guidance plus Purposeful Parenting.
干预措施: Purposeful Parenting (Behavioral)
Control Group
Families randomized to the control group will receive usual anticipatory guidance, delivered at the discretion of their pediatric provider, at each well-child visit in the first 12 months of life.
结局指标
主要结局
Responsive Parenting
时间窗: 6 months post intervention (child is 18 months)
Responsive parenting will be assessed using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLOTM), which involves an observer watching a 10 minute videotaped interaction to assess interaction between a parent and her infant or toddler. The PICCOLO is well-validated with inter-rater reliability=0.77; scale reliability=0.78; content, construct and predictive validity are acceptable.
Responsive Parenting
时间窗: At intervention conclusion (child is 12 months)
Responsive parenting will be assessed using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLOTM), which involves an observer watching a 10 minute videotaped interaction to assess interaction between a parent and her infant or toddler. The PICCOLO is well-validated with inter-rater reliability=0.77; scale reliability=0.78; content, construct and predictive validity are acceptable.
次要结局
- Parental knowledge of infant/toddler development, health and safety, and positive parenting practices(At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months))
- Parenting stress(At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months))
- Satisfaction and confidence in parenting skills(At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months))
研究者
Megan Bair-Merritt
Associate Professor of Pediatrics
Boston Medical Center