The Bucharest Early Intervention Project: Effects of Early Psychosocial Deprivation on Mental Health in Adolescence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Changes in Caregiving Environment
研究概览
简要总结
The purpose of this study is to determine the long term effects of early intervention (placement into foster care) on physical, cognitive, social and brain development and psychiatric symptomatology in previously institutionalized children.
详细描述
The Bucharest Early Intervention Project (BEIP) was a randomized controlled trial of foster care as an intervention for children abandoned at or around the time of birth and placed in one of six institutions for young children in Bucharest, Romania (Zeanah et al., 2003). The PI (Nelson) and Co-PIs (Zeanah and Fox) conducted this study beginning in the fall of 2000 from baseline assessments and implementation of the intervention in the spring of 2001.
The BEIP began with comprehensive assessments of 136 institutionalized children and their caregiving environments prior to randomization. Half the children were randomly assigned to high-quality foster care and the other half to remain in institutional care. The average age at foster care placement was 22 months (range=6-31 months). All children were initially seen prior to randomization and again for follow-up assessments at 30 months, 42 months 54 months, 8 years, 12 year and 16 years of age. The development of children in foster care was compared to the development of children in institutions and to a group of never institutionalized children (community controls). These children, now young adults are being assessed at age 21 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Changes in Caregiving Environment
时间窗: baseline, 30 mos and 42 mos
Observational Record of Caregiving Environment
Changes in Brain Structure
时间窗: 8 years, 16 years, 21 years
MRI
Changes in Cognition in young adulthood
时间窗: 21 years
Wechsler Adult Intelligence Scale
Changes in Cognition in early childhood
时间窗: baseline, 30 months, 42 months
Bayley Scales of Infant Development
Changes in Face Recognition
时间窗: baseline, 30 mos, 42 mos and 8 years
Event-related Potentials
Changes in EEG Power Brain Function
时间窗: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
EEG power
Changes in EEG Asymmetry Brain Function
时间窗: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
EEG asymmetry
Changes in Attachment Disturbances and Disorders
时间窗: baseline, 30 mos, 42 mos, 54 mos, 8 years, 12 years, 16 years
Disturbances of Attachment Interview
Changes in Attachment Style
时间窗: baseline, 30 mos and 42 mos
Strange Situation Procedure
Changes in weight
时间窗: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
weight in kilograms
Changes in height
时间窗: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Height measured in centimeters
Changes in head circumference
时间窗: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
Head circumference in centimeters
Changes in Genetics
时间窗: 8 years, 12 years, 16 years
Buccal Swab
Changes in Cognition in later childhood and adolescence
时间窗: 8 years, 12 years, 16-18 years
Wechsler Intelligence Scale for Children-IV
Changes in Psychiatric Symptomatology in adolescence
时间窗: 12 years, 16 years
Diagnostic Interview Schedule for Children -IV
Changes in Expressive Language Quality
时间窗: 30 mos, 42 mos and 8 years
language sample from interview
Changes in Emotion Discrimination
时间窗: baseline, 30 mos, 42 mos and 8 years
Event-related Potentials
Changes in Social Communication and Interaction
时间窗: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years
Social Communication Questionnaire
Changes in EEG Coherence Brain Function
时间窗: baseline, 30 mos, 42 mos, 8 years, 12 years, 16 years, 21 years
EEG coherence
Changes in Psychiatric Symptomatogology
时间窗: 21 years
Diagnostic Interview Schedule + Substance Abuse Module
Changes in Indiscriminate Behavior
时间窗: 54 mos, 8 years and 12 years
Stranger at the Door
Changes in Problem Behaviors
时间窗: baseline, 30 mos and 42 mos
Infant Toddler Social Emotional Assessment
次要结局
- Changes in Emotional Reactivity/Temperament(baseline, 30 mos and 42 mos)
- Motor Skills(8 years)
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