Early Institutionalization Intervention Impact Project
概览
- 阶段
- 不适用
- 干预措施
- Caregiving Intervention
- 疾病 / 适应症
- Socioemotional Development
- 发起方
- Boston Children's Hospital
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Differences in security of attachment
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
The purpose of this study is to determine the effects of early intervention (placement into foster care, and a caregiving training) on physical, cognitive, social and brain development and psychiatric symptomatology in children place in out-of-home care.
详细描述
The Early Institutionalization Intervention Impact (EI-3) Project will document and compare the impact of enhanced institutional care on early childhood development to that of high-quality foster care. We will recruit a large (n= 220) samples of young children who have been identified as having to be removed from their families and we will randomize these children to two groups: enhanced institutional care (Group 1) or to enhanced foster care (Group 2). Institutional caregivers and Foster Parents will participate in a caregiving training, along with the child, that includes 8-1.5 hour sessions over 8-9 weeks. In this Randomized Control Trial (RCT), we will assess the children in Groups 1 and 2 at the time they come into care and then at several follow-up time points (12 months, 24 months, 36 months of age). We hypothesize that children placed into foster/family care (FCG) will display enhanced socioemotional development, and enhanced behavioral and neural patterns of attention, cognition and social cognition, compared to children placed in enhanced institutional care.
研究者
Charles Alexander Nelson III
Richard David Scott Chair in Pediatric Developmental Medicine Research, Professor of Pediatrics and Neuroscience
Boston Children's Hospital
入排标准
入选标准
- •newly entering the institution system in and near São Paulo, Brazil, and the institution director or foster parent is the guardian at the time of baseline,
- •at the time of baseline assessment the child is less than 24 months old,
- •the child's birth weight must be at or above 2500 grams; none should be small or large for dates.
排除标准
- •the child does not have a neurological or other genetic condition that severely impairs typical development (e.g. Cerebral Palsy, Fetal Alcohol Syndrome, Down Syndrome)
- •the child is below 2500 grams.
研究组 & 干预措施
Enhanced Institutional Care
Caregivers at institutions will participate in a caregiving training, called Attachment VideoFeedback Intervention (AVI). During AVI a trained interventionist meets with a caregiver and child in the home environment. The AVI Interventionist will meet with caregivers and children for 8, 1.5-hours sessions over 8-9 weeks to discuss recordings of children and their caregivers. As described above, the sessions will focus on creating a positive atmosphere by reinforcing positive interactions.
干预措施: Caregiving Intervention
Enhanced Foster Care
Foster parents will be recruited, consented to background checks, and trained in Portuguese. Hired foster parents will supported and monitored by project social workers and psychologists from local Foster Care programs. Foster parents will received frequent visits from the social workers, with visits occurring weekly for several months after placement of the child, then biweekly and later monthly. Project social workers will consult weekly with US staff experienced in dealing with young children in foster care. Additionally, foster parents will participate in the VIPP caregiving training, in the same format as that described in the Enhanced Institutional Care Arm: the VIPP Interventionist will meet with caregivers and children for 5, 2-hours sessions over 6-8 weeks to discuss recordings of children and their caregivers. As described above, the sessions will focus on creating a positive atmosphere by reinforcing positive interactions.
干预措施: Foster Care
Enhanced Foster Care
Foster parents will be recruited, consented to background checks, and trained in Portuguese. Hired foster parents will supported and monitored by project social workers and psychologists from local Foster Care programs. Foster parents will received frequent visits from the social workers, with visits occurring weekly for several months after placement of the child, then biweekly and later monthly. Project social workers will consult weekly with US staff experienced in dealing with young children in foster care. Additionally, foster parents will participate in the VIPP caregiving training, in the same format as that described in the Enhanced Institutional Care Arm: the VIPP Interventionist will meet with caregivers and children for 5, 2-hours sessions over 6-8 weeks to discuss recordings of children and their caregivers. As described above, the sessions will focus on creating a positive atmosphere by reinforcing positive interactions.
干预措施: Caregiving Intervention
结局指标
主要结局
Differences in security of attachment
时间窗: baseline, 12 mos, 24 mos, 36 mos
Strange Situation Procedure
Differences in Alpha Electroencephalogram (EEG) Power, Coherence and Functional Connectivity
时间窗: baseline, 12 mos, 24 mos, 36 mos
EEG power
次要结局
- Differences in Competence(baseline, 12 mos, 24 mos, 36 mos)
- Differences in Cognition in early Childhood(baseline, 12 mos, 24 mos, 36 mos)
- Differences in Attachment Disturbances and Disorders(baseline, 12 mos, 24 mos, 36 mos)