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

NCT ID: NCT01087112

Last Updated: 2010-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-06-30

Brief Summary

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.

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)

Conditions

Mother-child Relationship Disturbances

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Child Health Centre care

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Mother-Infant Psychoanalytic tmt

Intervention Type: BEHAVIORAL

Psychoanalytic sessions with mother and infant, at a median of 23 sessions 2 times weekly.

Interventions

Mother-Infant Psychoanalytic tmt

Psychoanalytic sessions with mother and infant, at a median of 23 sessions 2 times weekly.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MIP; CHCC

Eligibility 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.

• Minimum Eligible Age: 54 Months
• Maximum Eligible Age: 54 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Dept. of Woman and Child Health, Child and Adolescent Psychiatry Unit, Karolinska Institute

Principal Investigators

Björn Salomonsson, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet

Majlis Winberg Salomonsson, M.Sci.Psych.

Role: PRINCIPAL_INVESTIGATOR

Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet

Locations

Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Per-Anders Rydelius, Professor

Role: CONTACT

per-anders.rydelius@ki.se

++46851777205

Facility Contacts

Björn Salomonsson, Doct.student

Role: primary

bjorn.salomonsson@ki.se

+4686429998

Other Identifiers

MIPPS-02

Identifier Type: -

Identifier Source: org_study_id