Mother-infant Relational Disturbances Clinical Trial
— MIPPSOfficial title:
A Randomized Controlled Trial of Mother-Infant Psychoanalytic Treatment (MIP) and Treatment As Usual (TAU) at Child Health Centres (CHC)
| 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 |
| Verified date | January 2021 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Karolinska Institute | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet |
Sweden,
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.
| 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 |