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临床试验/NCT02497677
NCT02497677已完成不适用

Copenhagen Infant Mental Health Project: A Randomized Controlled Trial Comparing Circle of Security-Parenting and Care as Usual as Interventions Targeting Infant Mental Healths Risks

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 314 人开始时间: 2015年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
314
试验地点
2
主要终点
Maternal sensitivity

研究概览

简要总结

Infant mental health is a significant public health issue as early adversity and expose to childhood stress has life-long consequences for the affected children. Helping families at risk correct their adverse effects on the infant has the potential to halt a negative spiral effect where vulnerable parents fail to cope with an at-risk child - which in turn, adds to the child's vulnerability, negatively affects the parents, and so forth. Over a four year period, an estimated 17.600 dyads will be screened in the City of Copenhagen using standardized screening instruments in detecting infant social withdrawal (ADBB) and maternal postnatal depression (EPDS). A sample of 314 eligible parent(s) will enter into a clinical, randomized control trial to test the efficacy of an 8 week group counseling program, Circle of Security Parenting (COS-P) compared to Care as Usual(CAU) in enhancing maternal sensitivity, child attachment and cognitive development. CIMHP is the first large-scale randomized controlled study to test the efficacy of COS-P in promoting parental sensitivity, child attachment and cognitive development in Denmark. Results will provide evidence regarding the efficacy of an American short term indicated parenting group program when implemented in a Scandinavian country.

详细描述

Background and rationale Infant mental health is a significant public health issue as early adversity and exposure to early childhood stress has life-long consequences for these affected children on outcomes such physical and mental health, educational attainment, labor market success and family formation. Infants are - as a result of their dependency, vulnerability and relative social invisibility - more exposed to mental health risks than older children. Infants may be at risk due to a particular biological risk (e.g. infantile autism, retardation, prematurity, physical disabilities etc) or to psycho-social risks in the family (e.g. mentally ill parents, poverty, drug/alcohol abuse etc). Recent Danish estimates suggest that one in five families is at risk of inadequate parenting resources and child neglect.

There is by now solid evidence that the establishment of attachment relationships, i.e. a stable emotional bond with a caregiver - mostly the parent - is one of the most important developmental milestones in infancy. Early parent-child attachment relationships function as a blueprint for future social relationships and serve as a framework within which children learn how to deal with stressful situations and to regulate the accompanying negative emotions. Insecure and disorganized attachment is a significant risk for longitudinal child development and psychopathology, as the ability to regulate ones feelings of stress and negative emotions is important for a wide range of socio-emotional outcomes ranging from social competence, moral development and empathy, to academic achievement. Recent meta-analyses show that insecure and disorganized children have a higher risk of developing mental problems later in life. Insecurely attached children are also more likely than securely attached children to develop internalizing problems, such as anxiety and depressive symptoms, as well as externalizing problems such as aggressive behavior. For externalizing problems, the risk was even higher for disorganized children. Furthermore, research into early brain development indicates that brain development can be physiologically altered by severe stress imposed by neglect and inadequate parenting during a child's early years.

Evidence from attachment research shows that sensitive parenting, where the parent is alert and able to understand the infant's expression of emotional states and able to manage and meet the infant's needs contingently, adequately and in a comforting way will lead to the establishment of a pattern of secure attachment in the child. Lack of availability, inconsistent availability, misunderstanding of the infant's emotional expression and parental behavior that frightens the infant may all lead to an insure attachment and in the most severe cases a disorganized attachment. This is indicative of a breakdown of an organized (secure or insecure) attachment behavioral strategy. Disorganized attachment is considered to be the result of parental behavior that is frightening for the child. An extreme example of such behavior is child maltreatment, but all sorts of parental behavior that are not comprehensible for the child, such as dissociation, which is common in depressed parents, is potentially frightening for the child. This sort of behavior results in the paradoxical situation that the parent is a source of comfort and a source of fear at the same time. Thus, in stress situations the child does not know what to do, and the behavioral strategy collapses .

Infant social withdrawal indicates infant distress and early attachment disturbances and is a known risk factor for infant mental health. Infant social withdrawal is indicated by a lack of either positive (e.g. smiling, eye contact) or negative vocal protestations. Sustained withdrawal behavior in infants can be seen as a chronic diminution of the attachment system, which is gradually generalized into a diminished engagement and lowered reactivity to the environment at large. In more European countries the use of the validated systematic screening method, Alarm Distress Baby Scale (ADBB) for identifying infant delayed socio-emotional development in infant mental health clinics and in home visiting programs have shown promising results.

Postnatal depression (PND) is another known risk for infant mental health. A meta-analysis shows that up to 19% of new mothers may experience minor or major depression during the first months postpartum. If only including major depression, the prevalence was found to be 7.1 %. In a more recent European study, 1,066 women were followed from pregnancy to 12 months postpartum. The results indicated that 9.6% of new mothers may experience a major depressive episode during the first year after delivery. No estimates were given for minor depression. Most cases develop within the first three months with a peak incidence of about 4-6 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Mother lives in one of the participating three districts of Copenhagen
  • Mother is > 18 years old
  • Mother has an infant in the age of 2-12 months born at term (Gestational age (GA) 37-42) or born preterm (GA 30-36).
  • Mother speaks and understands Danish.
  • Mother is screened positive for symptoms of postnatal depression (EPDS >10) and fulfill criteria for diagnosis of depression assessed in a clinical interview (SCID-5/RV) conducted by a psychologist 10-20 days after EPDS screening AND/OR
  • Infant is scored to be socially withdrawn in two ADBB assessments (ADBB >5) conducted within a range of 10-20 days when the infant is 2, 4 or 8 months.
  • If there is a father/partner this person speaks and understands Danish or English.

排除标准

  • Infant autism and/or early retardation
  • Maternal bipolar disorder and/or psychotic disorder, known severe intellectual impairment, suicidal ideation and/or recent suicide attempt and/or present alcohol/substance abuse.
  • Family intends to move away from the Copenhagen area within the period of the intervention.

研究组 & 干预措施

Circle of Security-Parenting

Experimental

Circle of Security-Parenting (COS-P) is a brief educative group program for parents

干预措施: Circle of Security -Parenting (Behavioral)

Care as Usual (CAU)

Active Comparator

Care as usual (CAU) i.e. the active control condition will be standard practices for infants and families at risk in Copenhagen.

干预措施: Care as Usual (Behavioral)

结局指标

主要结局

Maternal sensitivity

时间窗: Assessed at follow-up (infant is 12-16 months)

Maternal sensitivity is observed during five minutes mother-infant interaction (free play), and will be assessed using Coding Interactive behavior (CIB, Feldman, 1998).

次要结局

  • Maternal Attachment(Assessed at follow-up (infant is 12-16 months))
  • Infant cognitive and language development(Assessed at follow-up (infant is 12-16 months))
  • Maternal overall psychological distress(Assessed at follow-up (infant is 12-16 months))
  • Parental Reflective Functioning, reported by mother and partner(Assessed at follow-up (infant is 12-16 months))
  • Infants socio-emotional development - maternal and partner's report(Assessed at follow-up (infant is 12-16 months))
  • Maternal Depressive Symptoms(Assessed at follow-up (infant is 12-16 months))
  • Infant-mother attachment quality(Assessed at follow-up (infant is12-16 months))
  • Infant Social withdrawal(Assessed at follow-up (infant is 12-16 months))
  • Family Functioning, reported by mother and partner(Assessed at follow-up (infant is 12-16 months))
  • Number of extra homes visits by the health nurse(Assessed at follow-up (infant is 12-16 months))
  • Maternal depression diagnosis(Assessed at follow-up (infant is 12-16 months))
  • Parental Stress, reported by mother and partner(Assessed at follow-up (infant is 12-16 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mette Væver

associate professor

University of Copenhagen

研究点 (2)

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