Social Circumstances, Parenting Techniques, and Infant Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in maternal mood and prevalence/severity of postpartum depression.
研究概览
简要总结
-
Investigators aim to assess a novel behavioral intervention (currently approved in Protocol #6285) behavioral intervention that promotes maternally-mediated behavioral changes in young infants to reduce the risk of postpartum depression in a group of low income women. More specifically, investigators aim to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior and thereby: (1) reduce the incidence and/or severity of postpartum maternal depression in low socioeconomic status (SES) women, and (2) improve the quality of mother-infant interaction and subsequent child development. Investigators will study:
-
The feasibility of applying this protocol with a low SES population
-
The effectiveness of the intervention compared to usual care
-
If the effects of the intervention can be detected in assessments of the quality of mother-infant interaction and infant neurocognitive development
-
Investigators aim to determine whether this behavioral intervention can affect infant development as measured by neurodevelopmental assessments and cortisol reactivity at 4 months of age.
详细描述
Developmental research consistently shows that postpartum depression has a negative impact on cognitive and emotional development during infancy and childhood. Low SES women face unique stressors and social challenges. Rates of postpartum depression are significantly higher in this group (23-33%) than in the general population (10-15%).
The purpose of this study is to understand how social circumstances, women's mood, and parenting techniques affect infant and child development. Specifically, investigators are interested in finding out whether a behavioral intervention, already being administered in IRB approved protocol #6285, targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, thereby reducing the incidence and/or severity of maternal depression and anxiety symptoms, improving the quality of the mother-infant interaction, and improving infant developmental outcomes.
By collecting stress reports from women from low SES backgrounds during pregnancy and the postpartum period and by conducting follow-up observational assessments of the quality of mother-infant interaction, infant learning, infant cortisol reactivity, and infant neurocognitive development, investigators hope to identify whether this intervention can effectively meet these aims.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy pregnant women between 24 and 38 weeks gestation (based on self-report)
- •Ages 18-45 (based on self-report)
- •English speaking (based on self-report)
- •Salary indicated to be at New York City standardized "Struggling level" or lower - $47,700 annual for a family of 4 (based on self-report)
- •Experiencing one or more of nine social adversity hardships (based on self report)
- •Experiencing a healthy pregnancy, free from any significant medical complication (based on self-report)
- •Receiving standard prenatal care (based on self-report)
排除标准
- •Multi-fetal pregnancy (based on self-report)
- •Smoking, illicit drug use, or alcohol use during pregnancy (based on self-report)
- •Acute medical illness or significant pregnancy complication (based on self-report)
- •Currently in weekly, individual psychotherapy - group therapy and psychiatric management ok (based on self-report)
- •Psychotic d/o; Bipolar I; Major Depressive d/o (based on M.I.N.I.)
结局指标
主要结局
Change in maternal mood and prevalence/severity of postpartum depression.
时间窗: 6 weeks postpartum, 10 weeks postpartum, 16 weeks postpartum
Investigators will be assessing and tracking the incidence and/or severity of postpartum depression with the use of mood and stress questionnaires (Hamilton Depression Scale, Hamilton Anxiety Scale, Perceived Stress Scale, Center for Epidemiological Studies Depression Scale) administered at 4-6 weeks postpartum, 10 weeks postpartum, and 16 weeks postpartum.
次要结局
- The effect of behavioral intervention for infants on infant development(4 months (infant age))
- The effect of behavioral intervention on infant sleep and fuss behavior(6 weeks, 4 months (infant age))
研究者
Catherine Monk
Professor of Medical Psychology
New York State Psychiatric Institute