|- candidate number||1765|
|- NTR Number||NTR457|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||16-okt-2005|
|- Secondary IDs||N/A |
|- Public Title||Improving positive interaction between depressed mothers and their infants:
A effect study on a preventive program for mother mother and child.
|- Scientific Title||A randomized controlled trial of an early intervention aimed at preventing relationship problems in depressed mothers and their infants.|
|- hypothesis||The 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) studied||Depressive disorders|
|- Inclusion criteria||1. 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 criteria||1. Comorbid psychotic disorders;|
2. manic depression;
3. substance abuse were excluded.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2000|
|- planned closingdate||31-dec-2005|
|- Target number of participants||71|
|- Interventions||Intervention: |
the mother-baby program comprising 8-10 home visits by an experienced prevention therapist.
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 outcome||Quality of the mother-child interaction.|
|- Secondary outcome||Infant attachment security and socio-emotional functioning. |
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Karin Doesum, van|
|- CONTACT for SCIENTIFIC QUERIES||Prof. C.M.H. Hosman|
|- Sponsor/Initiator ||University Medical Center St. Radboud, Department of Clinical Psychology|
(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)|
|- Publications||1. 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 summary||Infants 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.
Randomized controlled trial.
Eight Dutch outpatient treatment centers serving adults with serious mental disorders.
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.
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)|
|- RECORD||16-okt-2005 - 9-okt-2008|