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临床试验/NCT02737254
NCT02737254已完成4 期

The Effect of Oxytocin on the Training of Attachment-related Interpretation Bias in Middle Childhood

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Change in trust in mother

研究概览

简要总结

The purpose of this study is to investigate the effects of oxytocin and a cognitive bias modification (CBM) procedure on children's trust in their mother.

详细描述

Previous research has shown that children can be trained to interpret ambiguous interactions with mother in a more secure way by use of a CBM procedure. A secure attachment-related processing bias can causally increase children's trust in mother's availability. The present study tests whether intranasal administration of oxytocin can increase the effect of a secure cognitive bias training. Oxytocin is a neuropeptide that is involved in human attachment and bonding. Intranasal administration of oxytocin can increase trust among people. After oxytocin or placebo administration, children are either trained to interpret ambiguous interactions with mother in a secure way or receive a neutral training unrelated to interpretation of maternal behavior. Pre- and post-intervention children's trust in mother, support seeking behavior and interpretation of maternal behavior is assessed. Moreover, possible oxytocin side-effects will be monitored.

研究设计

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

入排标准

年龄范围
8 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Between 8 and 13 years old
  • Mother can also participate

排除标准

  • Known oxytocin allergy
  • Currently using medication
  • Kidney or cardial condition

研究组 & 干预措施

Oxytocin and Secure CBM training

Experimental

干预措施: Oxytocin (Drug)

Oxytocin and Secure CBM training

Experimental

干预措施: Secure CBM training (Other)

Placebo and Secure CBM training

Active Comparator

干预措施: Placebo (Drug)

Placebo and Secure CBM training

Active Comparator

干预措施: Secure CBM training (Other)

Oxytocin and Neutral CBM training

Active Comparator

干预措施: Oxytocin (Drug)

Oxytocin and Neutral CBM training

Active Comparator

干预措施: Neutral CBM training (Other)

Placebo and Neutral CBM training

Placebo Comparator

干预措施: Placebo (Drug)

Placebo and Neutral CBM training

Placebo Comparator

干预措施: Neutral CBM training (Other)

结局指标

主要结局

Change in trust in mother

时间窗: Immediately before and immediately after intervention

Trust in mother as measured by People in My Life Trust subscale.

次要结局

  • Change in attachment-related behavior towards mother(Immediately before and immediately after intervention)
  • Change in secure interpretation of ambiguous maternal behavior(Immediately before and immediately after intervention)
  • Change in insecure interpretation of ambiguous maternal behavior(Immediately before and immediately after intervention)
  • Interpretation speed of positive maternal behavior(Throughout the CBM training, from around 60 minutes until 110 minutes after the start of the procedure)
  • Interpretation speed of negative maternal behavior(Throughout the CBM training, from around 60 minutes until 110 minutes after the start of the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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