Trial Outcomes & Findings for Mother-Infant Psychoanalysis Project of Stockholm (NCT NCT00923559)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

Two interviews, six months apart

Results posted on

2021-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	40	40
Overall Study COMPLETED	38	37
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	2	3

Baseline Characteristics

Mother-Infant Psychoanalysis Project of Stockholm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mother-Infant Psychoanalytic Treatment;MIP n=40 Participants 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.	TAU at Child Health Centres n=40 Participants 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.	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34.0 years STANDARD_DEVIATION 3.5 • n=5 Participants	32.3 years STANDARD_DEVIATION 4.6 • n=7 Participants	33.2 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Sweden	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Mother-Infant Psychoanalytic Treatment;MIP n=38 Participants A psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst recruits 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 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.	Treatment as Usual at Child Health Centre n=37 Participants Treatment as usual with nurse visits at Child Health Centres as part of regular Swedish child health care.
The Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005)	83.53 Scores on a scale Interval 79.56 to 87.5	76.67 Scores on a scale Interval 72.74 to 80.6

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Mother-Infant Psychoanalytic Treatment;MIP n=38 Participants A psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst recruits 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 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.	Treatment as Usual at Child Health Centre n=37 Participants Treatment as usual with nurse visits at Child Health Centres as part of regular Swedish child health care.
the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987)	6.28 Scores on a scale Interval 4.82 to 7.74	7.99 Scores on a scale Interval 6.56 to 9.43

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Mother-Infant Psychoanalytic Treatment;MIP n=38 Participants A psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst recruits 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 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.	Treatment as Usual at Child Health Centre n=37 Participants Treatment as usual with nurse visits at Child Health Centres as part of regular Swedish child health care.
the Ages and Stages Questionnaire: Social-Emotional, (ASQ:SE; Squires et al., 2002	1.00 Scores on a scale Interval 0.77 to 1.24	1.14 Scores on a scale Interval 0.9 to 1.37

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Mother-Infant Psychoanalytic Treatment;MIP n=38 Participants A psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst recruits 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 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.	Treatment as Usual at Child Health Centre n=37 Participants Treatment as usual with nurse visits at Child Health Centres as part of regular Swedish child health care.
the Swedish Parental Stress Questionnaire, (SPSQ; Östberg et al., 1997)	2.67 Scores on a scale Interval 2.5 to 2.85	2.74 Scores on a scale Interval 2.57 to 2.91

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Mother-Infant Psychoanalytic Treatment;MIP n=38 Participants A psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst recruits 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 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.	Treatment as Usual at Child Health Centre n=37 Participants Treatment as usual with nurse visits at Child Health Centres as part of regular Swedish child health care.
the Emotional Availability Scales, Subscale on Sensitivity (EAS; Biringen, 1998)	0.64 Scores on a scale Standard Deviation 0.12	0.57 Scores on a scale Standard Deviation 0.17

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mother-Infant Psychoanalytic Treatment;MIP n=38 Participants A psychoanalytic method adapted to the requirements of the infant as analysand in the presence of his mother. The analyst recruits 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 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.	Treatment as Usual at Child Health Centre n=37 Participants Treatment as usual with nurse visits at Child Health Centres as part of regular Swedish child health care.
General Severity Index of the Symptom Check List-90	0.57 Scores on a scale Interval 0.42 to 0.71	0.68 Scores on a scale Interval 0.54 to 0.83

Adverse Events

Mother-Infant Psychoanalytic Treatment;MIP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TAU at Child Health Centres

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Björn Salomonsson

Dept of Women's and Children's Health, Karolinska Institutet

Phone: +46851777206

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place