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临床试验/NCT03300713
NCT03300713进行中(未招募)不适用

MOther-Child Interaction Assessment TRAINING for Pediatricians

University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 3,504 人开始时间: 2017年12月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
3,504
试验地点
2
主要终点
Frequency of pathological Alarm Distress BaBy (ADBB) scores

研究概览

简要总结

The originality of the MOCITRAINING study lies in the integration of infant and maternal care during the pediatric consultation and the assessment of the impact of this type of care in the short and medium term on The MOCITRAINING program could contribute to improving the quality of parent-child interactions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
23 Days 至 37 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Each child will be included WITH his biological mother at the first-month visit after birth.
  • Age: 1 month + / - 15 days (child), accompanied by his biological mother
  • Mother able to read French;
  • Signed consent letter after complete information of parents about the MOCITRAINING study, its principle, advantages and disadvantages.

排除标准

  • Preterm babies.
  • Children from a twin or multiple pregnancy.
  • Children with somatic diagnosis explaining the presence of digestive, sleeping or interactional disorders.
  • Refusal to participate after clear information about the study;
  • Refusal to sign the consent letter;
  • Refusal to be informed of a diagnostic hypothesis;
  • Participants not covered by the Social Security system;
  • Participants incapable of consenting or under legal protection (guardianship or curatorship).

研究组 & 干预措施

F+ group (Mocitraining program)

Experimental

including 8 pediatricians' clusters. F+ pediatricians will attend a specific training focused on mother-child interactions, maternal psychiatric disorders, particularly PND screening and early interventions for non-psychiatric physician.

干预措施: MOCITRAINING program (Other)

F- group (usual follow-up)

Sham Comparator

grouping 8 pediatricians' clusters. They will not receive the initial training on early interactional disorders and PND screening

干预措施: usual follow-up (Other)

结局指标

主要结局

Frequency of pathological Alarm Distress BaBy (ADBB) scores

时间窗: in 12-month-aged children.

次要结局

  • Frequency of dyads referred for psychiatric or perinatal psychiatric consultations(in 4, 9, 12 and 24 month-aged children)
  • Frequency of digestive disorders(in 4, 9, 12 and 24 month-aged children)
  • Number of daytime sleep hours(in 4, 9, 12 and 24 month-aged children)
  • Number of nighttime awakenings(in 4, 9, 12 and 24 month-aged children)
  • Scores on maternal self-evaluation scales (Likert scales)(at 12 and 24 months postpartum)
  • Frequency of maternal psychotropic medication(in 4, 9, 12 and 24 month-aged children)
  • Frequency of pathological Alarm Distress BaBy (ADBB) scores(in 4, 9 and 24 month-aged children)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (2)

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