Mother-Infant Psychoanalysis Project of Stockholm

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Mother-infant Relational Disturbances

Intervention / Treatment
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* Other: Treatment as Usual at Child Health Centre
* Other: Mother-Infant Psychoanalytic treatment (MIP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mother-Infant Psychoanalytic treatment;MIP<br>MIP intervention | Other: Mother-Infant Psychoanalytic treatment (MIP)<br>* MIP (Norman, 2001; 2004) is a psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. In the study, the analysts strived to recruit the baby for an emotional interchange, though this did not imply any belief that the infant would understand verbal communication. Rather, the analyst addressed the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst took care in enrolling the participant mother. This was to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space to vent her own frustration, depression and anxiety.<br>|
| Active Comparator: TAU at Child Health Centres<br>Regular nurse visits at Child Health Centres according to Swedish infant health care. | Other: Treatment as Usual at Child Health Centre<br>* Treatment as usual (TAU) involved scheduled nurse calls at the local Child Health Centre (CHC), with paediatric checkups at 2 and 6 months of age. The nurse is encouraged to promote attachment and to detect postnatal depressions. Mothers might be offered parental groups, infant massage or guidance promoting interaction, as well as appointments with a paediatrician or a child psychiatric psychologist. Within the TAU framework, additional treatment might be initiated by the nurse or the mother. This was registered at the end-point interview.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005) | 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. | Two interviews, six months apart | 
| the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987) | 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. | Two interviews, six months apart | 
| the Ages and Stages Questionnaire: Social-Emotional, (ASQ:SE; Squires et al., 2002 | 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. | Two interviews, six months apart | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Swedish Parental Stress Questionnaire, (SPSQ; Östberg et al., 1997) | A Swedish-language version of the Parenting Stress Index (PSI; Abidin, 1990) with 35 items, each ranging 1-5 points. Higher scores indicate a worse outcome. | Two interviews six months apart | 
| the Emotional Availability Scales, Subscale on Sensitivity (EAS; Biringen, 1998) | The EAS assessed video-taped mother-baby interactions of 10' duration on three maternal dimensions (Sensitivity, Structuring, Non-intrusiveness) and two infant dimensions (Responsiveness and Involvement. The raw scores of the subscales have different ranges (0-5, 0-7, and 0-9). To enable comparison across subscales, we divided scores in each subscale with its maximal score. This yielded a range for each subscale of 0-1.Thus, the total score range for all subscales was 0-1, with higher scores indicating a better outcome. Here we report results on Sensitivity. | Two interviews, six months apart | 
| General Severity Index of the Symptom Check List-90 | The Symptom Check List-90 (SCL-90; Derogatis, 1994), with a Swedish language version (Fridell, Cesarec, Johansson, & Malling Thorsen, 2002), is a self-report questionnaire containing 90 items rated from 0 to 4. Higher scores indicate a worse outcome. The General Severity Index (GSI, or the mean across all items) was used to measure maternal general psychological distress. | two assessments at six month-interval |