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

Official Title: “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.

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)

Intervention(s) in this Clinical Trial

• Behavioral: Mother-Infant Psychoanalytic tmt
  • Psychoanalytic sessions with mother and infant, at a median of 23 sessions 2 times weekly.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.

Primary Measures

• Child functioning: Children's Global Assessment Scale
  • Time Frame: At followup interview
    Safety Issue?: No
• Maternal depression: Edinburgh Postnatal Depression Scale
  • Time Frame: At followup interview
    Safety Issue?: No

Secondary Measures

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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 54 Months

Maximum Age for this Clinical Trial: 54 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Karolinska Institutet Other

Overall Clinical Trial Officials and Contacts

Björn Salomonsson, MD Principal Investigator Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet  

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01087112

Study ID Number: MIPPS-02

ClinicalTrials.gov Identifier: NCT01087112

Health Authority: Sweden: Regional Ethical Review Board