Clinical trial NCT01087112: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Mother-child Relationship Disturbances
Keywords: MIP
RCT
postnatal depression
Mother-child relationship
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2010-03-16
Enrollment: 71
Sex: ALL
Minimum age (years): 54
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Child functioning: Children's Global Assessment Scale
timeFrame: At followup interview
measure: Maternal depression: Edinburgh Postnatal Depression Scale
timeFrame: At followup interview
Secondary outcomes:
measure: Maternal distress: Symptom Check List - 90
timeFrame: At followup interview
measure: Maternal stress: Swedish Parental Stress Questionnaire
timeFrame: At followup interview
measure: Child functioning: Ages and Stages Questionnaire:Social Emotional
timeFrame: At followup interview
measure: Child functioning: Strengths and Difficulties Questionnaire
timeFrame: At followup interview
measure: Child cognitive functioning: Wechsler's Preschool and Primary Scales of Intelligence
timeFrame: At followup interview
measure: Child's social and emotional functioning: Story Stem Attachment Profile
timeFrame: At followup interview
measure: Child's social and emotional functioning: Machover Draw-a-Person test
timeFrame: At followup interview
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet
Study officials:
affiliation: Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet
name: Björn Salomonsson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Women's and Children's Health, Child and Adolescent Psychiatry Unit, Karolinska Institutet
name: Majlis Winberg Salomonsson, M.Sci.Psych.
role: PRINCIPAL_INVESTIGATOR
References: