Well Being And Resilience: Mechanisms of Transmission of Health and Risk in Parents With Complex Mental Health Problems and Their Offspring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 3
- 主要终点
- Infant attachment as measured by Strange Situation Procedure (Ainsworth et al. 1978)
研究概览
简要总结
The purpose of this study is to establish a cohort of pregnant women with severe mental disorder and to identify biological and psycho-social transmission mechanisms involved in the development of 'risk' and 'resilience' in the offspring. It is assumed that both 'resilient' and 'risk' development in offspring are caused by a complex interaction between multiple biological, psychological and social factors. The project focuses specifically on exploring the impact of physiological stress-sensitivity, attachment, care-giving and the familial and social context for care-giving. Previous studies support these factors as important for the development of these infants, but systematic research using a prospective design is needed to strengthen evidence and elucidate the importance of these factors in more detail. The interaction over time of physiological stress-sensitivity, attachment, care-giving and the familial and social context for care-giving are evaluated in terms of the evolution of very early indicators of developmental risk and resilience in infants with a known highly increased risk for developing a mental disorder.The findings of the study may potentially lead to more specific targets for preventive interventions, which can improve developmental outcome for these infants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with Psychotic Disorder (DSM-5: Delusional Disorder (297.1)
- •Schizophreniform Disorder (295.4), Schizophrenia (295.90), Schizoaffective Disorder (295.70)
- •Brief Psychotic Disorder (298.8) Other specified schizophrenia spectrum and other psychotic disorder (298.8), Unspecified schizophrenia spectrum and other psychotic disorder (298.9) )
- •Lifetime diagnosis of DSM-5 Bipolar I and II Disorder (296.89)
- •Diagnosis of DSM-5 Major Depressive Disorder current single episode (current 296.22 - 296.25) or recurrent episode (296.32 - 296.35)
- •Non-psychiatric control group defined as mothers without any history of treatment or admission for a psychiatric disorder or drug or alcohol addiction.
- •Partners of participating women with an expected care-giving role in relation to the infant will also be eligible for participation in the study.
- •Infants of participating pregnant women will be included from birth.
排除标准
- •Unable to provide informed consent to participate
- •Unable to speak English or Danish because of the requirement to complete assessments,
- •Miscarriage.
结局指标
主要结局
Infant attachment as measured by Strange Situation Procedure (Ainsworth et al. 1978)
时间窗: At infant 52 weeks of age
Strange Situation Procedure is a structured observation. The infant is videotaped in a playroom during a series of eight structured 3-min episodes involving the baby, the mother, and a female stranger. During the observation the mother leaves and rejoins the infant twice, first leaving the infant with the female stranger, then leaving the infant alone to be rejoined by the stranger. The procedure is designed to be mildly stressful in order to increase the intensity of activation of the infant's attachment behavior. Videotapes are coded for four attachment classifications: secure, avoidant, ambivalent-resistant/dependent and disorganised.
次要结局
- Infant neurobehavioral outcome as measured by Neonatal Intensive Care Unit Neurobehavioral Scale, NNNS, (Lester & Tronick, 2005)(1-7 days and 4 weeks)
- Infant social-interactive behavior as measured by Coding Interactive Behavior, CIB (Ruth Feldman, 2012)(1-7 days, 4 and 16 weeks)
- Infant development as measured by Bayley's scales for infant development 3rd edition (BSID-III-R, Bayley, 2006)(16 and 52 weeks of infant age)
- Infant stress exposure and physiological stress-sensitivity as measured by hair and salivary cortisol(1-7 days (hair only) 4 (Saliva only), 16 and 52 weeks of infant age)
研究者
Susanne Harder
Associate Professor
University of Copenhagen