Mother-infant Relational Disturbances
Conditions
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).
Interventions
OTHERTreatment 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.
OTHERMother-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.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005) | 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) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| the Swedish Parental Stress Questionnaire, (SPSQ; Östberg et al., 1997) | Two interviews six months apart | 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. |
| the Emotional Availability Scales, Subscale on Sensitivity (EAS; Biringen, 1998) | Two interviews, six months apart | 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. |
| General Severity Index of the Symptom Check List-90 | two assessments at six month-interval | 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. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
Baseline characteristics
| Characteristic | TAU at Child Health Centres | Mother-Infant Psychoanalytic Treatment;MIP | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 40 Participants | 80 Participants |
| Age, Continuous | 32.3 years STANDARD_DEVIATION 4.6 | 34.0 years STANDARD_DEVIATION 3.5 | 33.2 years STANDARD_DEVIATION 4.2 |
| Region of Enrollment Sweden | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 40 Participants | 40 Participants | 80 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 38 | 0 / 37 |
| serious Total, serious adverse events | 0 / 38 | 0 / 37 |
Outcome results
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.
Time frame: Two interviews, six months apart
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mother-Infant Psychoanalytic Treatment;MIP | the Ages and Stages Questionnaire: Social-Emotional, (ASQ:SE; Squires et al., 2002 | 1.00 Scores on a scale |
| Treatment as Usual at Child Health Centre | the Ages and Stages Questionnaire: Social-Emotional, (ASQ:SE; Squires et al., 2002 | 1.14 Scores on a scale |
Comparison: Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.p-value: 0.26695% CI: [-0.21, 0.75]Regression, Linear
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.
Time frame: Two interviews, six months apart
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mother-Infant Psychoanalytic Treatment;MIP | the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987) | 6.28 Scores on a scale |
| Treatment as Usual at Child Health Centre | the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987) | 7.99 Scores on a scale |
Comparison: Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.p-value: 0.01895% CI: [0.46, 4.68]Regression, Linear
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.
Time frame: Two interviews, six months apart
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mother-Infant Psychoanalytic Treatment;MIP | The Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005) | 83.53 Scores on a scale |
| Treatment as Usual at Child Health Centre | The Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005) | 76.67 Scores on a scale |
Comparison: Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.p-value: 0.00695% CI: [2.64, 14.74]Regression, Linear
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.
Time frame: two assessments at six month-interval
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mother-Infant Psychoanalytic Treatment;MIP | General Severity Index of the Symptom Check List-90 | 0.57 Scores on a scale |
| Treatment as Usual at Child Health Centre | General Severity Index of the Symptom Check List-90 | 0.68 Scores on a scale |
Comparison: Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.p-value: 0.15895% CI: [-0.05, 0.31]Mixed Models Analysis
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.
Time frame: Two interviews, six months apart
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mother-Infant Psychoanalytic Treatment;MIP | the Emotional Availability Scales, Subscale on Sensitivity (EAS; Biringen, 1998) | 0.64 Scores on a scale | Standard Deviation 0.12 |
| Treatment as Usual at Child Health Centre | the Emotional Availability Scales, Subscale on Sensitivity (EAS; Biringen, 1998) | 0.57 Scores on a scale | Standard Deviation 0.17 |
Comparison: see under the PIR-GASp-value: 0.03195% CI: [-1.61, -0.08]Regression, Linear
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.
Time frame: Two interviews six months apart
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mother-Infant Psychoanalytic Treatment;MIP | the Swedish Parental Stress Questionnaire, (SPSQ; Östberg et al., 1997) | 2.67 Scores on a scale |
| Treatment as Usual at Child Health Centre | the Swedish Parental Stress Questionnaire, (SPSQ; Östberg et al., 1997) | 2.74 Scores on a scale |
Comparison: Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.p-value: 0.05295% CI: [0, 0.32]Regression, Linear