Group Family Nurture Intervention: Short and Long Term Effects on Preschool Aged Children and Their Mothers at Children's Learning Centers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in Videotaped Interrupted Welch Lap Test
研究概览
简要总结
The purpose of this study is to compare the effects of Family Nurture Intervention in a mother-child group setting with a Standard Children's Learning Center (CLC) Program for preschool-aged children (ages 2-4.5). This approach is based on creating emotional connection and establishing mother-child two-way regulation, which the investigators hypothesize affects early child development. Mothers and children will be engaged by Nurture Specialists in comforting and calming interactions to regulate each other physically-leading to an automatic calming response to contact with each other.
详细描述
This study tests a group model of Family Nurture Intervention (FNI), a novel family-based intervention that facilitates mother-child emotional connectedness and co-regulation. Many current interventions aim at helping the child to self-regulate with or without the mother's help. However, according to the investigators' Calming Cycle Theory, the ability of the mother-child dyad to promote optimal development is dependent on the dyad's ability to co-regulate. The interactive co-regulation between the mother and the child shapes the behavior of both. This study aims to investigate the short and long term effects of FNI in a multiple family group setting for preschool aged children to prevent and/or treat developmental/behavioral problems.
Previously, FNI implemented in the Neonatal Intensive Care Unit (NICU) for premature infants and their mothers at Columbia University Medical Center demonstrated that FNI positively alters neurodevelopment of premature infants. Infants who received FNI in the NICU demonstrated increased brain activity in the prefrontal cortex at term age, improved cognitive and language development at 18 months as measured by the Bayley Scales of Infant Development, improved behavior on the Child Behavior Checklist (CBCL) and reduced risk for autism as indicated by the Modified Checklist for Autism in Toddlers (M-CHAT) at 18 months. The pilot study of FNI with preschool aged children and their mothers shows a 40% reduction in behavioral problems on the CBCL. Accordingly, the investigators hypothesize that the Family Nurture Intervention will alter physiological regulatory capacities and will result in improved indices of mother-child emotional connection and other outcomes in the preschool population similar to the results in the preterm population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 24 Months 至 57 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother is able to consent in English or Spanish
- •Mother is 18 years of age or older at the time of consent
- •Child is between the ages of 2 to 4 years and 9 months at date of enrollment
- •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
- •Mother is currently involved with the Department of Children and Families (DCF)
结局指标
主要结局
Change in Videotaped Interrupted Welch Lap Test
时间窗: Baseline, after 8 sessions/weeks and at 6-months post-accrual
Mother-child interactions 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
- Respiration(Baseline, after 8 sessions/weeks and at 6-months post-accrual)
- ECG(Baseline, after 8 sessions/weeks and at 6-months post-accrual)
- Change in Maternal Symptoms of Anxiety and Depression(Baseline, after 8 sessions/weeks and at 6-months post-accrual)
研究者
Martha G Welch
Associate Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)
Columbia University