A Randomized Controlled Trial of Mother-Infant Psychoanalytic Treatment (MIP) and Treatment As Usual (TAU) at Child Health Centres (CHC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005)
研究概览
简要总结
Mother-infant relationship disturbances broadly comprise three areas; maternal distress, infant functional problems, and relationship difficulties. Given the high frequency of such disturbances and the relative paucity of randomized treatment studies, substantial systematic investigation is needed. This project is a randomized controlled study comparing mother-infant psychoanalytic treatment with treatment as usual in cases where mothers and/or health visitors demanded expert help.
详细描述
DESIGN
Eighty dyads with infants below 1½ years of age were interviewed and then randomly assigned to MIP or TAU. An end-point interview followed after ½ year, evaluating the intervention effects.
The MIP treatments were performed by IPA psychoanalysts at the Infant Reception Service of the Swedish Psychoanalytic Society. TAU implied contact with a nurse at a Child Health Centre, as part of regular Swedish health care of infants and mothers. Additional treatments within the TAU framework suggested at the initiative by the health visitor or the mother were registered at the end-point interview.
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 General Severity Index of the Symptom Check List-90 (Derogatis, 1994)and the Swedish Parental Questionnaire (SPSQ; Östberg et al., 1997).
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
- — 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
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.
- •Substance dependence according to DSM-IV, to an extent precluding collaboration.
- •No mothers met these criteria.
结局指标
主要结局
The Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005)
时间窗: Two interviews, six months apart
An observer-rated scale ranging from 0 to 99, from "documented maltreatment" to "well-adapted". Higher scores indicate a better outcome. Inter-rater reliability was measured with an external experienced infant psychotherapist.
the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987)
时间窗: Two interviews, six months apart
The EPDS (Swedish translation, Lundh \& Gylland, 1990), is a self-report questionnaire containing 10 items each with a 3-point scale. Range: 0 - 30. Higher scores indicate a worse outcome. It is widely used at Swedish CHCs and has been validated on samples in Sweden.
the Ages and Stages Questionnaire: Social-Emotional, (ASQ:SE; Squires et al., 2002
时间窗: Two interviews, six months apart
Items are mostly rated on a 4-step scale, with 0,5,10 or 15 points per item, where 0 is most optimal. There are three versions for the age ranges of this study: 3-8, 9-14, and 15-20 months. To enable comparison across age groups we report mean scores across all items. Higher scores indicate a worse outcome. Each version was independently translated into Swedish, retranslated and approved by the constructor.
次要结局
- the Swedish Parental Stress Questionnaire, (SPSQ; Östberg et al., 1997)(Two interviews six months apart)
- General Severity Index of the Symptom Check List-90(two assessments at six month-interval)
- the Emotional Availability Scales, Subscale on Sensitivity (EAS; Biringen, 1998)(Two interviews, six months apart)
研究者
Bjorn Salomonsson
Doct. student
Karolinska Institutet