Ignite Creation Date:
2024-05-05 @ 9:36 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00923559
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2009-06-17
Brief Title:
Mother-Infant Psychoanalysis Project of Stockholm
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
A Randomized Controlled Trial of Mother-Infant Psychoanalytic Treatment MIP and Treatment As Usual TAU at Child Health Centres CHC
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIPPS
Brief Summary:
Mother-infant relationship disturbances broadly comprise three areas maternal distress infant functional problems and relationship difficulties Given the high frequency of such disturbances and the relative paucity of randomized treatment studies substantial systematic investigation is needed This project is a randomized controlled study comparing mother-infant psychoanalytic treatment with treatment as usual in cases where mothers andor health visitors demanded expert help
Detailed Description:
DESIGN
Eighty dyads with infants below 1½ years of age were interviewed and then randomly assigned to MIP or TAU An end-point interview followed after ½ year evaluating the intervention effects
The MIP treatments were performed by IPA psychoanalysts at the Infant Reception Service of the Swedish Psychoanalytic Society TAU implied contact with a nurse at a Child Health Centre as part of regular Swedish health care of infants and mothers Additional treatments within the TAU framework suggested at the initiative by the health visitor or the mother were registered at the end-point interview
INSTRUMENTS
Mother-report questionnaires the Ages and Stages QuestionnaireSocial-Emotional ASQSE Squires et al 2002 the Edinburgh Postnatal Depression Scale EPDS Cox et al 1987 the General Severity Index of the Symptom Check List-90 Derogatis 1994and the Swedish Parental Questionnaire SPSQ Östberg et al 1997
Time frame All four instruments were measured at intake interviews and six months later
Independently rated video-taped mother-infant interactions the Emotional Availability Scale EAS Biringen 1998
Relationship assessment the Parent-Infant Relationship Global Assessment Scale PIR-GAS ZERO-TO-THREE 2005
Eighty dyads with infants below 1½ years of age were interviewed and then randomly assigned to MIP or TAU An end-point interview followed after ½ year evaluating the intervention effects
The MIP treatments were performed by IPA psychoanalysts at the Infant Reception Service of the Swedish Psychoanalytic Society TAU implied contact with a nurse at a Child Health Centre as part of regular Swedish health care of infants and mothers Additional treatments within the TAU framework suggested at the initiative by the health visitor or the mother were registered at the end-point interview
INSTRUMENTS
Mother-report questionnaires the Ages and Stages QuestionnaireSocial-Emotional ASQSE Squires et al 2002 the Edinburgh Postnatal Depression Scale EPDS Cox et al 1987 the General Severity Index of the Symptom Check List-90 Derogatis 1994and the Swedish Parental Questionnaire SPSQ Östberg et al 1997
Time frame All four instruments were measured at intake interviews and six months later
Independently rated video-taped mother-infant interactions the Emotional Availability Scale EAS Biringen 1998
Relationship assessment the Parent-Infant Relationship Global Assessment Scale PIR-GAS ZERO-TO-THREE 2005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None