Mother-Infant Psychoanalysis Project of Stockholm (MIPPS)- Follow-up at 4½ Years (MIPPS-02)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Karolinska Institutet.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01087112
First received: December 29, 2009
Last updated: March 15, 2010
Last verified: December 2009
  Purpose

An RCT comparing mother-infant psychoanalytic treatment (MIP) with Child Health Centre care in cases of mother-infant relationship disturbances was performed on 80 cases in Stockholm 2005-2008. The infants were < 18 months at interview #1. At 6 months follow-ups, significant effects were shown in favour of MIP on maternal sensitivity (EAS), depression (EPDS), and relationship qualities PIR-GAS). This study will evaluate effects at a child age of 4½ years; to evaluate the longterm effects of MIP and CHild Health Centre care, and to better validate results on children who now have reached an age where they can participate more actively in evaluations.


Condition Intervention Phase
Mother-child Relationship Disturbances
Behavioral: Mother-Infant Psychoanalytic tmt
Behavioral: Child Health Centre care
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Follow-up Study of 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:
  • Child functioning: Children's Global Assessment Scale [ Time Frame: At followup interview ] [ Designated as safety issue: No ]
  • Maternal depression: Edinburgh Postnatal Depression Scale [ Time Frame: At followup interview ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal distress: Symptom Check List - 90 [ Time Frame: At followup interview ] [ Designated as safety issue: No ]
  • Maternal stress: Swedish Parental Stress Questionnaire [ Time Frame: At followup interview ] [ Designated as safety issue: No ]
  • Child functioning: Ages and Stages Questionnaire:Social Emotional [ Time Frame: At followup interview ] [ Designated as safety issue: No ]
  • Child functioning: Strengths and Difficulties Questionnaire [ Time Frame: At followup interview ] [ Designated as safety issue: No ]
  • Child cognitive functioning: Wechsler's Preschool and Primary Scales of Intelligence [ Time Frame: At followup interview ] [ Designated as safety issue: No ]
  • Child's social and emotional functioning: Story Stem Attachment Profile [ Time Frame: At followup interview ] [ Designated as safety issue: No ]
  • Child's social and emotional functioning: Machover Draw-a-Person test [ Time Frame: At followup interview ] [ Designated as safety issue: No ]

Estimated Enrollment: 71
Study Start Date: December 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Child Health Centre care
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. Additional treatment was initiated in 1/3 of the cases. This was registered at the end-point interview.
Behavioral: Child Health Centre care
Nurse calls at Child Health Centres (CHC), with regular paediatric checkups. The nurse was encouraged to promote attachment and to detect postnatal depressions. Appointments with a psychiatrist or therapist or child psychiatric psychologist was initiated in 1/3 of the cases. This was registered at the end-point interview.
Other Name: CHCC
Experimental: Mother-Infant Psychoanalytic tmt
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 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.
Behavioral: Mother-Infant Psychoanalytic tmt
Psychoanalytic sessions with mother and infant, at a median of 23 sessions 2 times weekly.
Other Name: MIP

Detailed Description:

DESIGN

The 71 dyads remaining from the MIPPS-01 study will be interviewed when the children have reached 4½ years, in order to evaluate the long-term intervention effects of MIP treatments delivered by psychoanalysts at the Infant Reception Service of the Swedish Psychoanalytic Society and of the usual treatments of infants and children in Sweden implying contact with nurses at Child Health Centres.

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 Swedish Parental Questionnaire (SPSQ; Östberg et al., 1997) and the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997).

Independently rated video-taped mother-child interactions: the Emotional Availability Scale (EAS; Biringen, 1998).

Assessment of the general functioning of the child : Children's Global Assessment Scale (Shaffer et al 1983).

Assessment of the child's cognitive functioning: Wechsler Preschool and Primary Scale of Intelligence (WPPSI, Wechsler, 2005).

Assessment of the child's social and emotional functioning: Story Stem Attachment Profile (SSAP, Hodges et al., 2003). Machover Draw-a-Person Test (Blomberg & Cleve, 1997)

  Eligibility

Ages Eligible for Study:   54 Months to 54 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 according to DSM-IV, to an extent precluding collaboration.
  • Substance dependence according to DSM-IV, to an extent precluding collaboration.
  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: NCT01087112

Contacts
Contact: Per-Anders Rydelius, Professor ++46851777205 per-anders.rydelius@ki.se

Locations
Sweden
Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet Recruiting
Stockholm, Sweden, 11641
Contact: Björn Salomonsson, Doct.student    +4686429998    bjorn.salomonsson@ki.se   
Sub-Investigator: Majlis Winberg Salomonsson, M.Sci.Psych.         
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Björn Salomonsson, MD Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet
Principal Investigator: Majlis Winberg Salomonsson, M.Sci.Psych. Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet
  More Information

No publications provided

Responsible Party: Björn Salomonsson, Dept. of Woman and Child Health, Child and Adolescent Psychiatry Unit, Karolinska Institute
ClinicalTrials.gov Identifier: NCT01087112     History of Changes
Other Study ID Numbers: MIPPS-02
Study First Received: December 29, 2009
Last Updated: March 15, 2010
Health Authority: Sweden: Regional Ethical Review Board
Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska Institutet:
MIP
RCT
postnatal depression
Mother-child relationship

ClinicalTrials.gov processed this record on August 21, 2014