Mother-infant Relational DisturbancesMIPPSNCT00923559

Mother-Infant Psychoanalysis Project of Stockholm

A study testing Treatment as Usual at Child Health Centre and Mother-Infant Psychoanalytic treatment (MIP) in people with Mother-infant Relational Disturbances, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages Up to 18 months
Conditions the study is for: Mother-infant Relational Disturbances
What is being tested?: Treatment as Usual at Child Health Centre and Mother-Infant Psychoanalytic treatment (MIP)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteSweden
Study dates: Oct 2005to Dec 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 18 months
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

Maternal psychosis.
Substance dependence according to DSM-IV, to an extent precluding collaboration.
No mothers met these criteria.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Karolinska Institute
Stockholm, 17176

Other trials in Sweden

About this study

Official title: A Randomized Controlled Trial of Mother-Infant Psychoanalytic Treatment (MIP) and Treatment As Usual (TAU) at Child Health Centres (CHC)

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.

Read the 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).

Conditions: Mother-infant Relational Disturbances
Being tested: Treatment as Usual at Child Health Centre, Mother-Infant Psychoanalytic treatment (MIP)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment as Usual at Child Health CentreOther
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)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.

Study groups in NCT00923559
Study group	Role	What they receive
Mother-Infant Psychoanalytic treatment;MIP	Experimental	MIP intervention Receives: Other: Mother-Infant Psychoanalytic treatment (MIP)
TAU at Child Health Centres	Active comparator	Regular nurse visits at Child Health Centres according to Swedish infant health care. Receives: Other: Treatment as Usual at Child Health Centre

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Two interviews, six months apart

Secondary outcomes (3)

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.
Measured: Two interviews six months apart
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.
Measured: 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.
Measured: two assessments at six month-interval

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2005Dec 2008

First posted18 Jun 2009 (estimated)
Study startOct 2005
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Mother-infant Relational DisturbancesStudies of the same condition, open and under way.
More trials run by Karolinska InstitutetThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00923559
Sponsor's protocol ID: MIPPS-01
Acronym: MIPPS
Status last verified: Jan 2021
First submitted: 17 Jun 2009
Last updated: 29 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 17244571
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.
PubMed 17908677
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.
PubMed 28543080
Salomonsson, B. (2009). Mother-infant work and its impact on psychoanalysis with adults. Scandinavian Psychoanalytic Review, 32, 3-13.
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.
PubMed 28520149
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.
PubMed 26908296
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.
PubMed 26904966

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial of Mother-Infant Psychoanalytic Treatment (MIP) and Treatment As Usual (TAU) at Child Health Centres (CHC)
ClinicalTrials.gov ID: NCT00923559
Acronym / sponsor ID: MIPPS / MIPPS-01
Conditions: Mother-infant Relational Disturbances
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Karolinska InstitutetUniversity, hospital or other
Study start: Oct 2005 (actual)
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 18 Jun 2009 (estimated)
Results: Posted 29 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

INSTRUMENTS

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mother-Infant Psychoanalytic treatment;MIP	Experimental	Other: Mother-Infant Psychoanalytic treatment (MIP)MIP intervention
TAU at Child Health Centres	Active comparator	Other: Treatment as Usual at Child Health CentreRegular nurse visits at Child Health Centres according to Swedish infant health care.

Who may qualify

Ages: Up to 18 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (3 listed)

Maternal psychosis.
Substance dependence according to DSM-IV, to an extent precluding collaboration.
No mothers met these criteria.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment as Usual at Child Health CentreTreatment 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.	Other	TAU at Child Health Centres
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.	Other	Mother-Infant Psychoanalytic treatment;MIP

Primary outcome

The Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005)
Time frame: 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)
Time frame: 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
Time frame: 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.

3 secondary outcomes

the Swedish Parental Stress Questionnaire, (SPSQ; Östberg et al., 1997)
Time frame: Two interviews six months apart
the Emotional Availability Scales, Subscale on Sensitivity (EAS; Biringen, 1998)
Time frame: Two interviews, six months apart
General Severity Index of the Symptom Check List-90
Time frame: two assessments at six month-interval

Results and safety

Results posted to the registry on 29 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mother-Infant Psychoanalytic Treatment;MIP	40	38
TAU at Child Health Centres	40	37

Primary outcome: The Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005)

Time frame: Two interviews, six months apart. Mean (95% Confidence Interval). Unit: Scores on a scale

Measure	Mother-Infant Psychoanalytic Treatment;MIP n = 38	Treatment as Usual at Child Health Centre n = 37
Value	83.53 (79.56 to 87.50)	76.67 (72.74 to 80.60)

Mother-Infant Psychoanalytic Treatment;MIP vs Treatment as Usual at Child Health Centre: Mean Difference (Final Values): 8.69 (95% CI 2.64 to 14.74), p = .006, Regression, Linear

Population analysed: 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.

Primary outcome: the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987)

Time frame: Two interviews, six months apart. Mean (95% Confidence Interval). Unit: Scores on a scale

Measure	Mother-Infant Psychoanalytic Treatment;MIP n = 38	Treatment as Usual at Child Health Centres n = 37
Value	6.28 (4.82 to 7.74)	7.99 (6.56 to 9.43)

Mother-Infant Psychoanalytic Treatment;MIP vs Treatment as Usual at Child Health Centres: Mean Difference (Final Values): 2.57 (95% CI 0.46 to 4.68), p = .018, Regression, Linear

Primary outcome: the Ages and Stages Questionnaire: Social-Emotional, (ASQ:SE; Squires et al., 2002

Time frame: Two interviews, six months apart. Mean (95% Confidence Interval). Unit: Scores on a scale

Measure	Mother-infant Psychoanalytic Treatment; MIP n = 38	Treatment as Usual at Child Health Centres n = 37
Value	1.00 (0.77 to 1.24)	1.14 (0.90 to 1.37)

Mother-infant Psychoanalytic Treatment; MIP vs Treatment as Usual at Child Health Centres: Mean Difference (Net): 0.27 (95% CI -0.21 to 0.75), p = .266, Regression, Linear

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mother-Infant Psychoanalytic Treatment;MIP	0 of 38 (0%)	0 of 38 (0%)	Not reported
TAU at Child Health Centres	0 of 37 (0%)	0 of 37 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17244571Salomonsson 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.
Background: PubMed 17908677Salomonsson 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.
Background: PubMed 28543080Salomonsson 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.
BackgroundSalomonsson, B. (2009). Mother-infant work and its impact on psychoanalysis with adults. Scandinavian Psychoanalytic Review, 32, 3-13.
Background: PubMed 28520149Salomonsson 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.
Results publication: PubMed 26908296Salomonsson 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.
Results publication: PubMed 26904966Salomonsson 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.
Describes the research project and its clinical utility in lay languageLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Per-Anders Rydelius, Professor study director

Karolinska Institutet

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005) (time frame: Two interviews, six months apart). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00923559, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.