Norwalk Drop-In Family Nurture Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Mother-child session interest
研究概览
简要总结
The purpose of this study is two-fold: 1) to examine the feasibility of the Drop-In model of Family Nurture Intervention (FNI); and 2) to collect pilot data concerning the mother's response to the Drop-In model of FNI and short term effects of participation. Feasibility of the Program will be measured through costs, staffing, space availability, and uptake. Participation in the Drop-In entails weekly visits for FNI. The investigators hypothesize that the Family Nurture Intervention will show feasibility through attendance and positive response to the Drop-In format. The investigators also expect the Family Nurture Intervention to improve mother's perceived well-being and mother-child emotional connection.
详细描述
Family Nurture Intervention (FNI) is a novel family-based program that facilitates mother-child emotional connection and co-regulation. Many current interventions aim at helping the child to self-regulate with or without the mother's help. However, the ability of the mother-child dyad to promote optimal development is dependent on their ability to co-regulate. The interactive co-regulation between the mother and the child shapes the behavior of both the mother and the child.
This study aims to investigate the feasibility and short term effects of participation in the Family Nurture Intervention for preschool aged children with developmental and behavior problems. Mothers and children will be engaged by Nurture Specialists in comforting and calming interactions to co-regulate with each other during weekly group sessions with the support of study staff. Intervention sessions will occur over the course of eight weeks, and each mother will decide how many sessions to attend.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 24 Months 至 78 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother is fluent in English or Spanish
- •Mother is 18 years of age or older at the time of consent
- •Mother-child pair does not demonstrate emotional connection as measured by the WECS
- •Child is between the ages of 2 to 4½ years at date of enrollment (child must be younger than 4 years and 9 months at baseline assessment) or between 2 to 4½ at date of enrollment in study AAAQ9547
- •Child resides with mother
排除标准
- •The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral Palsy
- •The child has a diagnosis of Autism Spectrum Disorder
- •The child has severe motor or physical disability
- •Mother currently presents with psychosis or is currently taking antipsychotic medication
- •Current maternal drug and/or alcohol abuse
- •Mother is more than four months pregnant
- •Mother and/or infant has a medical condition or contagion that precludes intervention components
- •Mother is unable to commit to study schedule
结局指标
主要结局
Mother-child session interest
时间窗: 8 weeks
Study staff will track interest level and engagement with FNI through weekly forms and notes; mothers will be asked to give feedback on their experience of the study at the completion of eight weeks.
Change in videotaped Welch Lap Test
时间窗: 8 weeks
Mother-child 5-minute videotaped interactions, recorded weekly after each session, will be assessed for social engagement and emotional connection via the Welch Emotional Connection Screen (WECS). The Welch Emotional Connection Scale (WECS) construct is emotional connection between mother and child, which the investigators hypothesize predicts optimal development. There are four items on the WECS: Mutual Attraction, Mutual Vocal Exchange, Mutual Facial Engagement, and Mutual Sensitivity/Reciprocity. Each item is rated on a scale from 1 to 3 in 0.25 increments with a score of 3 considered optimal. There is also a binary question to the rater asking if the pair is emotionally connected - yes or no. The mother and child are scored as a pair, not individually.
次要结局
未报告次要终点