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临床试验/NCT01087112
NCT01087112Unknown早期 1 期

A Follow-up Study of a Randomized Controlled Trial of Mother-Infant Psychoanalytic Treatment and Treatment As Usual at Child Health Centres

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
早期 1 期
入组人数
71
试验地点
2
主要终点
Child functioning: Children's Global Assessment Scale

研究概览

简要总结

An RCT comparing mother-infant psychoanalytic treatment (MIP) with Child Health Centre care in cases of mother-infant relationship disturbances was performed on 80 cases in Stockholm 2005-2008. The infants were < 18 months at interview #1. At 6 months follow-ups, significant effects were shown in favour of MIP on maternal sensitivity (EAS), depression (EPDS), and relationship qualities PIR-GAS). This study will evaluate effects at a child age of 4½ years; to evaluate the longterm effects of MIP and CHild Health Centre care, and to better validate results on children who now have reached an age where they can participate more actively in evaluations.

详细描述

DESIGN

The 71 dyads remaining from the MIPPS-01 study will be interviewed when the children have reached 4½ years, in order to evaluate the long-term intervention effects of MIP treatments delivered by psychoanalysts at the Infant Reception Service of the Swedish Psychoanalytic Society and of the usual treatments of infants and children in Sweden implying contact with nurses at Child Health Centres.

INSTRUMENTS

Mother-report questionnaires; the Ages and Stages Questionnaire:Social-Emotional (ASQ:SE; Squires et al., 2002), the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987), the Swedish Parental Questionnaire (SPSQ; Östberg et al., 1997) and the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997).

Independently rated video-taped mother-child interactions: the Emotional Availability Scale (EAS; Biringen, 1998).

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
None

入排标准

年龄范围
54 Months 至 54 Months(Child)
性别
All
接受健康志愿者

入选标准

  • The mother expressed significant concerns about one or more of the following domains: herself as a mother, her infant's well-being, or the mother-baby relationship (this was operationalized as a score < 80 ("perturbed relation") on the PIR-GAS or, alternatively, > 2.5 on the SPSQ).
  • Infant of any gender, age below 18 months.
  • Duration of worries exceeding two weeks.
  • Domicile in Stockholm.
  • Reasonable mastery of Swedish.

排除标准

  • Maternal psychosis according to DSM-IV, to an extent precluding collaboration.
  • Substance dependence according to DSM-IV, to an extent precluding collaboration.

结局指标

主要结局

Child functioning: Children's Global Assessment Scale

时间窗: At followup interview

Maternal depression: Edinburgh Postnatal Depression Scale

时间窗: At followup interview

次要结局

  • Maternal distress: Symptom Check List - 90(At followup interview)
  • Maternal stress: Swedish Parental Stress Questionnaire(At followup interview)
  • Child functioning: Ages and Stages Questionnaire:Social Emotional(At followup interview)
  • Child functioning: Strengths and Difficulties Questionnaire(At followup interview)
  • Child cognitive functioning: Wechsler's Preschool and Primary Scales of Intelligence(At followup interview)
  • Child's social and emotional functioning: Story Stem Attachment Profile(At followup interview)
  • Child's social and emotional functioning: Machover Draw-a-Person test(At followup interview)

研究者

申办方类型
Other

研究点 (2)

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