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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00923559
Other study ID # MIPPS-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2005
Est. completion date December 2008

Study information

Verified date January 2021
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Months
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Mother-infant Relational Disturbances

Intervention

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

Locations

Country Name City State
Sweden Karolinska Institute Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (7)

Salomonsson B, Sandell R. A randomized controlled trial of mother-infant psychoanalytic treatment: I. Outcomes on self-report questionnaires and external ratings. Infant Ment Health J. 2011 Mar;32(2):207-231. doi: 10.1002/imhj.20291. — View Citation

Salomonsson B, Sandell R. A randomized controlled trial of mother-infant psychoanalytic treatment: II. Predictive and moderating influences of qualitative patient factors. Infant Ment Health J. 2011 May;32(3):377-404. doi: 10.1002/imhj.20302. — View Citation

Salomonsson B, Sleed M. The Ages & Stages Questionnaire: Social-Emotional: A validation study of a mother-report questionnaire on a clinical mother-infant sample. Infant Ment Health J. 2010 Jul;31(4):412-431. doi: 10.1002/imhj.20263. — View Citation

Salomonsson B. "Talk to me baby, tell me what's the matter now". Semiotic and developmental perspectives on communication in psychoanalytic infant treatment. Int J Psychoanal. 2007 Feb;88(Pt 1):127-46. — View Citation

Salomonsson B. Semiotic transformations in psychoanalysis with infants and adults. Int J Psychoanal. 2007 Oct;88(Pt 5):1201-21. — View Citation

Salomonsson B. The music of containment: Addressing the participants in mother-infant psychoanalytic treatment. Infant Ment Health J. 2011 Nov;32(6):599-612. doi: 10.1002/imhj.20319. Epub 2011 Nov 3. — View Citation

Salomonsson, B. (2009). Mother-infant work and its impact on psychoanalysis with adults. Scandinavian Psychoanalytic Review, 32, 3-13.

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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