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

A Follow-up Study of a Randomized Controlled Trial of Mother-Infant Psychoanalytic Treatment and Treatment As Usual at Child Health Centres

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.

Study Overview

• Status: Unknown
• Conditions: Mother-child Relationship Disturbances
• Intervention / Treatment: Behavioral: Child Health Centre care; Behavioral: Mother-Infant Psychoanalytic tmt

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)

• Study Type: Interventional
• Enrollment (Anticipated): 71
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11641
    • Recruiting
    • Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet
    • Contact: Björn Salomonsson, Doct.student; Phone Number: +4686429998; Email: bjorn.salomonsson@ki.se
    • Sub-Investigator: Majlis Winberg Salomonsson, M.Sci.Psych.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: MIP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Child functioning: Children's Global Assessment Scale	At followup interview
Maternal depression: Edinburgh Postnatal Depression Scale	At followup interview

Secondary Outcome Measures

Outcome Measure	Time Frame
Maternal distress: Symptom Check List - 90	At followup interview
Maternal stress: Swedish Parental Stress Questionnaire	At followup interview
Child functioning: Ages and Stages Questionnaire:Social Emotional	At followup interview
Child functioning: Strengths and Difficulties Questionnaire	At followup interview
Child cognitive functioning: Wechsler's Preschool and Primary Scales of Intelligence	At followup interview
Child's social and emotional functioning: Story Stem Attachment Profile	At followup interview
Child's social and emotional functioning: Machover Draw-a-Person test	At followup interview

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: December 29, 2009
• First Submitted That Met QC Criteria: March 15, 2010
• First Posted (Estimate): March 16, 2010

Study Record Updates

• Last Update Posted (Estimate): March 16, 2010
• Last Update Submitted That Met QC Criteria: March 15, 2010
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: RCT; postnatal depression; MIP; Mother-child relationship
• Other Study ID Numbers: MIPPS-02