Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mother-Infant Psychoanalytic treatment;MIP | Experimental | MIP intervention |
|
| TAU at Child Health Centres | Active Comparator | Regular nurse visits at Child Health Centres according to Swedish infant health care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment as Usual at Child Health Centre | Other | 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. |
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
No mothers met these criteria.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Per-Anders Rydelius, Professor | Karolinska Institutet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institute | Stockholm | 17176 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17244571 | Background | 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. doi: 10.1516/04p3-fuer-0u41-lln8. | |
| 17908677 | Background | Salomonsson B. Semiotic transformations in psychoanalysis with infants and adults. Int J Psychoanal. 2007 Oct;88(Pt 5):1201-21. doi: 10.1516/ijpa.2007.1201. |
| Label | URL |
|---|---|
| Describes the research project and its clinical utility in lay language | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. The analyst strives to recruit the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother. This is to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space vent her frustration, depression and anxiety. |
| FG001 | TAU at Child Health Centres | 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 may be offered parental groups, infant massage or guidance promoting interaction, as well as appointments with a paediatrician or a child psychiatric psychologist. Within the CHC framework, additional treatment may initiated by the nurse or the mother. This will be registered at the end-point interview. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. The analyst strives to recruit the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother. This is to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space vent her frustration, depression and anxiety. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Outliers (z-transformed scores>3.29) were replaced by raw scores corresponding to z=3.29. Multivariate outliers identified via Mahalanobi's distance through a multiple regression, none found. Missing data were very rare and missing at random. No scores imputed. Intention to treat (ITT)analysis was used. | Posted | Mean | 95% Confidence Interval | Scores on a scale | Two interviews, six months apart |
|
6 months
Mothers were invited to contact the investigator about any adverse events. The follow-up interviews 6 months after the first thoroughly investigated adverse effects.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. The analyst strives to recruit the baby for an emotional interchange, though this does not imply any belief that the infant understands verbal communication. The analyst addresses the baby to help him liberate emotions consolidated in symptoms such as screaming, avoiding maternal eye contact, and breast refusal. The analyst also enrolls the participant mother. This is to enhance her understanding of the baby's predicament and the nature of their relation, as well as giving her space vent her frustration, depression and anxiety. |
Not provided
Not provided
The assumption that assignment to Treatment As Usual (TAU) at Child Health Centres (CHC) would generate disappointment was contradicted: pre-treatment data were more optimal in this group. The final number of non-completers was roughly equal in the two treatment groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Björn Salomonsson | Dept of Women's and Children's Health, Karolinska Institutet | +46851777206 | bjorn.salomonsson@ki.se |
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Mother-Infant Psychoanalytic treatment (MIP) | Other | 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. |
|
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 |
| 28543080 | Background | 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. |
| Background | Salomonsson, B. (2009). Mother-infant work and its impact on psychoanalysis with adults. Scandinavian Psychoanalytic Review, 32, 3-13. |
| 28520149 | Background | 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. |
| 26908296 | Result | 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. |
| 26904966 | Result | 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. |
| BG001 | TAU at Child Health Centres | 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 may be offered parental groups, infant massage or guidance promoting interaction, as well as appointments with a paediatrician or a child psychiatric psychologist. Within the CHC framework, additional treatment may initiated by the nurse or the mother. This will be registered at the end-point interview. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Treatment as Usual at Child Health Centre | Treatment as usual with nurse visits at Child Health Centres as part of regular Swedish child health care. |
|
|
|
| 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. | Outliers (z-transformed scores>3.29) were replaced by raw scores corresponding to z=3.29. Multivariate outliers identified via Mahalanobi's distance through a multiple regression, none found. Missing data were very rare and missing at random. No scores imputed. Intention to treat (ITT)analysis was used. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 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. | Outliers (z-transformed scores>3.29) were replaced by raw scores corresponding to z=3.29.Multivariate outliers identified via Mahalanobi's distance through a multiple regression, none found. Missing data were very rare and missing at random. No scores imputed. Intention to treat (ITT)analysis was used. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 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. | Outliers (z-transformed scores>3.29) were replaced by raw scores corresponding to z=3.29. Multivariate outliers identified via Mahalanobi's distance through a multiple regression, none found. Missing data were very rare and missing at random. No scores imputed. Intention to treat (ITT)analysis was used. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 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. | Outliers (z-transformed scores>3.29) were replaced by raw scores corresponding to z=3.29. Multivariate outliers identified via Mahalanobi's distance through a multiple regression, none found. Missing data were very rare and missing at random. No scores imputed. Intention to treat (ITT)analysis was used. | Posted | Mean | Standard Deviation | Scores on a scale | 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | two assessments at six month-interval |
|
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | TAU at Child Health Centres | 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 may be offered parental groups, infant massage or guidance promoting interaction, as well as appointments with a paediatrician or a child psychiatric psychologist. Within the CHC framework, additional treatment may initiated by the nurse or the mother. This will be registered at the end-point interview. | 0 | 37 | 0 | 37 |
Not provided
Not provided