Mother-Infant Psychoanalysis Project of Stockholm (MIPPS)

This study has been completed.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00923559
First received: June 17, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Mother-Infant Relational Disturbances
Other: Treatment as Usual at Child Health Centre
Other: Mother-Infant Psychoanalytic treatment (MIP)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Mother-Infant Psychoanalytic Treatment and Treatment As Usual at Child Health Centres

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • the Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005) [ Time Frame: Two interviews, six months apart ] [ Designated as safety issue: No ]
  • the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987) [ Time Frame: Two interviews, six months apart ] [ Designated as safety issue: No ]
  • the Ages and Stages Questionnaire: Social-Emotional, (ASQ:SE; Squires et al., 2002 [ Time Frame: Two interviews, six months apart ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the Swedish Parental Stress Questionnaire, (SPSQ; Östberg et al., 1997) [ Time Frame: Two interviews six months apart ] [ Designated as safety issue: No ]
  • the Emotional Availability Scales, (EAS; Biringen, 1998) [ Time Frame: Two interviews, six months apart ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: October 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mother-Infant Psychoanalytic treatment;MIP
MIP intervention
Other: 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 whatsoever that the infant understands verbal communication. Rather, 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 takes great care in enrolling 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 all space needed to vent her own frustration, depression and anxiety.
Active Comparator: TAU
Treatment as usual
Other: Treatment as Usual at Child Health Centre
TAU involved scheduled health visitor calls at the local Child Health Centre (CHC), with paediatric checkups at 2 and 6 months of age. The health visitor 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 TAU framework, additional treatment may be initiated by the health visitor or the mother. This will be registered at the end-point interview.

Detailed Description:

DESIGN

Eighty dyads with infants below 1½ years of age are interviewed and then randomly assigned to MIP or TAU. An end-point interview follows after ½ year, evaluating the intervention effects.

The MIP treatments are performed by IPA psychoanalysts at the Infant Reception Service of the Swedish Psychoanalytic Society. TAU implies contact with a Health Visitor at a Child Health Centre. Additional treatments within the TAU framework suggested at the initiative by the health visitor or the mother are registered at the end-point interview. Each TAU case will also be investigated via CHC records.

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)and the Swedish Parental Questionnaire (SPSQ; Östberg et al., 1997).

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).

Prognostic assessment: the Mother-Baby Interview (MOBI; Salomonsson, 2009). Interview-based assessments of psychoanalytic aptitude and quality of the process.

Ideal typing (Stuhr&Wachholz, 2001) of "maternal types" and "infant types."

  Eligibility

Ages Eligible for Study:   up to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923559

Locations
Sweden
Deptartment of Woman and Child Health, Child and Adolescent Psychiatry Unit, Karolinska Institute
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Investigators
Study Director: Per-Anders Rydelius, Professor Dept. of Woman and Child Health, Child and Adolescent Psychiatry Unit, Karolinska Institute
  More Information

Publications:
Responsible Party: Björn Salomonsson, Dept. of Woman and Child Health, Child and Adolescent Psychiatry Unit, Karolinska Institute
ClinicalTrials.gov Identifier: NCT00923559     History of Changes
Other Study ID Numbers: MIPPS-01
Study First Received: June 17, 2009
Last Updated: June 17, 2009
Health Authority: Sweden: Swedish Research Council

ClinicalTrials.gov processed this record on October 16, 2014