Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-31 @ 7:19 PM
Study NCT ID:
NCT00923559
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2009-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mother-Infant Psychoanalysis Project of Stockholm
Sponsor:
Karolinska Institutet
Organization:
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 and/or 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 Questionnaire:Social-Emotional (ASQ:SE; 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, 1994)and 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 Questionnaire:Social-Emotional (ASQ:SE; 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, 1994)and 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:
True
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?: