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

Mother-child Relationship Disturbances Clinical Trial

— MIPPS-02  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01087112
• Other study ID #: MIPPS-02
• Status: Recruiting
• Phase: Phase 0
• First received: December 29, 2009
• Last updated: March 15, 2010
• Start date: December 2009
• Est. completion date: June 2013

Study information

• Verified date: December 2009
• Source: Karolinska Institutet
• Contact: Per-Anders Rydelius, Professor
• Phone: ++46851777205
• Email: per-anders.rydelius[@]ki.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 71
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 54 Months to 54 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mother-child Relationship Disturbances

Intervention

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

Locations

Country	Name	City	State
Sweden	Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child functioning: Children's Global Assessment Scale		At followup interview	No
Primary	Maternal depression: Edinburgh Postnatal Depression Scale		At followup interview	No
Secondary	Maternal distress: Symptom Check List - 90		At followup interview	No
Secondary	Maternal stress: Swedish Parental Stress Questionnaire		At followup interview	No
Secondary	Child functioning: Ages and Stages Questionnaire:Social Emotional		At followup interview	No
Secondary	Child functioning: Strengths and Difficulties Questionnaire		At followup interview	No
Secondary	Child cognitive functioning: Wechsler's Preschool and Primary Scales of Intelligence		At followup interview	No
Secondary	Child's social and emotional functioning: Story Stem Attachment Profile		At followup interview	No
Secondary	Child's social and emotional functioning: Machover Draw-a-Person test		At followup interview	No