Clinical Interventions to Mitigate Neurodevelopmental Risk
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in heart rhythm synchrony
研究概览
简要总结
Family Nurture Intervention (FNI) has been shown to facilitate emotional connection and long-term child developmental progress in the NICU population. It has been theorized that FNI also promotes autonomic co-regulation and physiological synchrony between the mother-child dyad. The goal of the pilot study is to assess how a short one-time FNI session between at-risk mother and child dyads in the Well Baby Nursery (WBN) influences physiological synchrony, emotional connection, and developmental changes both short and long-term.
详细描述
The long-term objective of this work is to improve cognitive, emotional, and social developmental trajectories in at-risk children. Specially, this pilot study will assess the feasibility of Family Nurture Intervention (FNI) in the neonatal period during the infants' stay in the Well Baby Nursery (WBN) in improving developmental trajectories.
FNI is a family-based intervention that facilitates and strengthens the mother-infant emotional connection through a structured guided interaction by a trained provider. Mother-infant emotional connection is known to affect various developmental processes and improve overall health. FNI was previously shown to be efficacious in improving several long-term health outcomes in preterm infants.
In this study, the goal is to extend of the findings of FNI to another population of at risk infants - infants born to mothers suffering from gestational diabetes mellitus (GDM). These infants are generally healthy but at higher risk than controls in developing mild cognitive and motor impairments.
In this pilot phase, infants exposed to GDM and case-matched control infants will both receive FNI: (GDM+FNI and Control+FNI). These two groups will be compared to an already existing protocol and pool of participants who did not receive FNI: (GDM+no FNI and Control+no FNI). This allows the study to evaluate both GDM versus control infants as well as the presence of FNI versus no FNI.
The goal is to pilot the potential role of a short, one-time session of FNI in promoting neurodevelopment among an at-risk wellbaby nursery population. This will be achieved by comparing developmental milestones, such as cognitive and motor development, memory, attention, and emotion regulation at 6 and 15 months, between participants who received the FNI and those who did not. Another goal is to elucidate the role FNI has on autonomic co-regulation and mother-infant synchrony through physiological recordings during the FNI session in the WBN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Hours 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically healthy mothers with and without diabetes (type 1, type 2, or gestational) and their infants
- •Infants with gestational age between 37 0/7 and 40 6/7
- •APGAR score above 7 five minutes after birth
- •Infants between 12-72 hours of life at time of the study
- •Mothers between 18-50 years old
排除标准
- •Infants with gestational age below 37 0/7 or above 40 6/7
- •Infant requiring resuscitation at birth
- •Infant admitted to NICU
- •Prenatal exposures to psychiatric medications, alcohol, recreational drug use, or smoking
- •HIV-positive mother
- •Mother with psychiatric diagnosis
- •Infant with genetic disorder
结局指标
主要结局
Change in heart rhythm synchrony
时间窗: Baseline
Heart rhythms will be collected through non-invasive EKG monitoring of mother and infant during FNI in order to test the hypothesis that FNI improves emotional connection through autonomic synchrony. To test this, peaks will be extracted from the EKG traces of mother and infant and cross-correlation functions will be used to assess if physiological synchrony between mother-infant heart beats increases throughout the FNI session. Synchrony at the end of the session will also be used to ascertain if autonomic synchrony can be used as a predictor of WECS score or other outcomes at the follow-up sessions.
Change in Welch Emotional Connection Score
时间窗: Baseline and 15-months of age
The Welch Emotional Connection Screen (WECS) is a validated scale for quantitative assessment of the emotional connection between infant and mother by scoring the interaction of the dyad in four domains: attraction, vocal communication, facial communication and sensitivity/reciprocity. Each domain is scored on a scale from 1.0 to 3.0 in 0.25 point increments, with higher scores indicating stronger emotional connection. The WECS will be measured at baseline for the FNI groups during the intervention, and at 15 months for both FNI and non-FNI groups by a researcher observing the dyadic interaction during a 3 minute period of face-to-face time. Changes in score from baseline to 15 months will be evaluated for FNI groups. Differences in emotional connection will be evaluated in FNI versus non-FNI groups by comparing WECS scores at 15-months.
Change in Ages and Stages questionnaire (ASQ-3) Score
时间窗: 6 months (over the phone) and 15 months (in person)
The ASQ-3 is a questionnaire aimed to pinpoint developmental progress in children between 1 month to 5.5 years in age. It is parent-centric and is administered through paper and pencil. It takes 10 to 15 minutes to complete. Change in score will be calculated by comparing ASQ-3 scores of FNI and non-FNI participants by measuring across five developmental areas: communication, gross motor, fine motor, problem solving, and personal-social.
Change in Social-Emotional Questionnaire (ASQ-SE) Score
时间窗: 6 months (over the phone) and 15 months (in person)
The ASQ-SE is a 22-item parent-completed, culturally sensitive questionnaire. It is a screening tool to identify young children who may have social and emotional development trends that warrant further evaluation. It takes 10 to 15 minutes to complete. Change in score will be calculated by comparing ASQ-SE scores of FNI and non-FNI participants measuring self-regulation, compliance, communication, adaptive behaviors, autonomy, affect, and interaction with people. This would be assessed
Change in Brief Infant Toddler Social Emotional Assessment (BITSEA) score
时间窗: 15 months
BITSEA is a short 42-item parent-report screening tool used to identify social-emotional/behavioral problems and delays in competence in 12 to 36 month olds. It takes 10 to 15 minutes to complete. The measure yields two scores: a Problem Total Score and Competence Total Score. It also includes a two separate parental "worry" item for parents to rate their concern about the child's behavior and language on a 5-point scale from 1 being not at all worried to 5 being extremely worried. Change in score will be calculated by comparing BITSEA scores of FNI and non-FNI participants.
次要结局
- Change in Edinburgh Postnatal Depression Scale (EPDS)(15 months)
- Change in Bayley-III Scale(15 months)
- Change in Toddler Sensory Profile-2 score(15 months)
- Change in M/CHAT R/F score(15 months)
- Change in Parenting Stress Index (PSI-4)(6 months (over the phone) and 15 months (in person))