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临床试验/NCT03578016
NCT03578016Unknown不适用

A Randomized and Controlled Trial Using Circle of Security-Parenting for Parents of Children Referred to Child Psychiatric Services.

Region Syddanmark2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2018年8月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
128
试验地点
2
主要终点
Maternal sensitivity

研究概览

简要总结

Background:The quality of attachment is greatly influenced by parental sensitivity. Attachment based interventions are designed to promote parental sensitivity, to change parental mental representations and to improve understanding of the developmental needs of the child. Very few studies have investigated the effect of attachment-based interventions on psychiatric symptoms in children. Targeting parental sensitivity and the parent-child interaction might have an important impact on psychiatric symptoms in a clinical sample of children referred to child psychiatric services.

Objectives: The primary objective is to investigate whether Circle of Security-Parenting (COS-P) has an effect on parental sensitivity in parents of children referred to child psychiatric services. The secondary objectives are to investigate the effect on children's behavioral and emotional symptoms and the parental stress and reflective functioning after 10 weeks of intervention and at the 24 week follow-up. The study is also exploring the effect of parental attachment style, parental stress and parental psychopathology on the effect of the intervention.

Methods: The trial will include 128 families of children (age 3-8 years) who are referred to child psychiatric services in a randomized and controlled design. Included families will be randomized to COS-P+ Treatment as Usual (TAU) or TAU only.

Perspectives: Considering the important impact of the quality of the parent-child relationship on the child's well-being, it is essential to target it in interventions and to investigate the relation with psychiatric symptoms. Generally there is a lack of interventions targeting parental sensitivity in psychiatric child populations. Working with the parents on the child-parent relation, might have an important impact on their children's current psychiatric symptoms and could additionally prevent future psychopathology.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children who score equal or above the 93d percentile on CBCL-total score
  • Score above 93d percentile on the CBCL- ODD or aggression scale
  • Informed consent from both custody.

排除标准

  • For children:
  • autism spectrum disorders
  • serious psychopathology requiring immediate clinical attention
  • head injury or verified neurological disease
  • intelligence quotient (IQ) <80
  • medical condition, requiring treatment
  • no informed consent from custody
  • For parents:
  • a diagnosis of schizophrenia
  • bipolar disorder
  • known substance abuse
  • severe intellectual impairment
  • suicide attempt in the past

结局指标

主要结局

Maternal sensitivity

时间窗: after 10 weeks of intervention

Maternal sensitivity is measured by observing a mother-child interaction and is rated using "Coding Interactive Behavior" (CIB)

次要结局

  • Berkeley Puppet interview(24 week follow-up)
  • Maternal Intrusiveness(24 week follow-up)
  • Maternal Sensitivity(24 week follow-up)
  • Dyadic reciprocity(24 week follow-up)
  • Negative states(24 week follow-up)
  • Child Behaviour Check List (CBCL)-Total score-parent rated(24 week follow-up)
  • CBCL-ODD score-parent rated. Score range: 0-26. Higher indicates more problems.(24 week follow-up)
  • Coping with childrens negative emotions scale(24 week follow-up)
  • Parental Reflective Functioning Questionnaire(24 week follow-up)
  • Eyberg Child Behaviour Inventory (ECBI)(24 week follow-up)

研究者

发起方
Region Syddanmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aida Bikic

assistant professor, ph.d.

Region Syddanmark

研究点 (2)

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