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Clinical Trials/NCT00923559
NCT00923559
Completed
Not Applicable

A Randomized Controlled Trial of Mother-Infant Psychoanalytic Treatment (MIP) and Treatment As Usual (TAU) at Child Health Centres (CHC)

Karolinska Institutet1 site in 1 country80 target enrollmentOctober 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mother-infant Relational Disturbances
Sponsor
Karolinska Institutet
Enrollment
80
Locations
1
Primary Endpoint
The Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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). Time frame: All four instruments were measured at intake interviews and six months later. Independently rated video-taped mother-infant interactions: the Emotional Availability Scale (EAS; Biringen, 1998). Relationship assessment: the Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005).

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
December 2008
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bjorn Salomonsson

Doct. student

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Maternal psychosis.
  • Substance dependence according to DSM-IV, to an extent precluding collaboration.
  • No mothers met these criteria.

Outcomes

Primary Outcomes

The Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005)

Time Frame: 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)

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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