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Improving positive interaction between depressed mothers and their infants: A effect study on a preventive program for mother mother and child.


- candidate number1765
- NTR NumberNTR457
- ISRCTNISRCTN83523136
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR16-okt-2005
- Secondary IDsN/A 
- Public TitleImproving positive interaction between depressed mothers and their infants: A effect study on a preventive program for mother mother and child.
- Scientific TitleA randomized controlled trial of an early intervention aimed at preventing relationship problems in depressed mothers and their infants.
- ACRONYMN/A
- hypothesisThe mother baby intervention positively affects the quality of the mother-child interaction, particularly the mother’s sensitivity towards her child and the child’s responsiveness and involvement, and (2) The intervention positively affects the children’s attachment security and socio-emotional functioning.
- Healt Condition(s) or Problem(s) studiedDepressive disorders
- Inclusion criteria1. Mothers with an infant not older than 12 months, who met the DSM-IV criteria for a major depressive episode or dysthymia and/or exhibited elevated levels of depressive symptoms (BDI >14);
2. psychiatric comorbidity was allowed.
- Exclusion criteria1. Comorbid psychotic disorders;
2. manic depression;
3. substance abuse were excluded.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2000
- planned closingdate31-dec-2005
- Target number of participants71
- InterventionsIntervention:
the mother-baby program comprising 8-10 home visits by an experienced prevention therapist.


Control condition:
3-month parenting support comprising three telephone contacts with a child therapist or.
All mothers concurrently received separate treatment by a psychiatrist of psychologist for their depressive symptoms.
- Primary outcomeQuality of the mother-child interaction.
- Secondary outcomeInfant attachment security and socio-emotional functioning.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Karin Doesum, van
- CONTACT for SCIENTIFIC QUERIESProf. C.M.H. Hosman
- Sponsor/Initiator University Medical Center St. Radboud, Department of Clinical Psychology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, The Foundation for Children’s Welfare Stamps Netherlands (Stichting Kinderpostzegels Nederland, SKN)
- Publications1. Van Doesum KTM, Hosman CMH, Riksen-Walraven JM. A model based intervention for depressed mothers and their infants. Inf Mental Hlth J. 2005;26(2):157-176.
2. Van Doesum KTM, Hosman CMH, Riksen-Walraven JM, Hoefnagels C Predicting depressed mothers’ sensitivity towards their infants: the role of maternal, child and contextual characteristics (in preparation).
3. Van Doesum KTM, Hosman CMH, Riksen-Walraven JM, Hoefnagels C. A randomized controlled trial of an early intervention aimed at preventing relationship problems in depressed mothers and their infants. Child Dev. 2008 May-Jun;79(3):547-61.
- Brief summaryInfants of depressed mothers are at high risk to develop mental and socio-emotional problems in adolescence and adulthood. Early interventions focused on improving mother-child interactions are deemed to benefit the infant’s development and prevent psychopathology. The effects of an early mother-baby intervention program on the quality of the mother-child interaction and infant attachment security and socio-emotional functioning was tested.

Design:
Randomized controlled trial.


Setting:
Eight Dutch outpatient treatment centers serving adults with serious mental disorders.


Participants:
Seventy-one depressed mothers, meeting the DSM-VI criteria for a depressive episode or dysthymia, with infants aged 1-12 months. Comorbid psychotic disorders, manic depression, and substance abuse were excluded, other psychiatric comorbidity was not.


Intervention:
Depressed mothers were randomly assigned to either the control (n = 36) or the experimental condition (n = 35), thus receiving either 3-month parenting support comprising three telephone contacts with a child therapist or the treatment program comprising 8-10 home visits by an experienced prevention therapist. All mothers concurrently received separate treatment by a psychiatrist of psychologist for their depressive symptoms.


Main outcome measures:
Quality of the mother-child interaction, infant attachment security and socio-emotional functioning.
- Main changes (audit trail)
- RECORD16-okt-2005 - 9-okt-2008


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