Contact information
Type
Scientific
Primary contact
Dr Karin Doesum, van
ORCID ID
Contact details
Radboud University Nijmegen
Department of Clinical Psychology
Prevention Research Centre
P.O. Box 9104
Nijmegen
6500 HE
Netherlands
vandoesumk@hetnet.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR457
Study information
Scientific title
Acronym
Study hypothesis
1. The mother baby intervention positively affects the quality of the mother-child interaction, particularly the mothers sensitivity towards her child and the childs responsiveness and involvement
2. The intervention positively affects the child's attachment security and socio-emotional functioning
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised single blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
Depressive disorders
Intervention
Intervention: 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
All mothers concurrently received separate treatment by a psychiatrist or psychologist for their depressive symptoms.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Quality of the mother-child interaction
Secondary outcome measures
Infant attachment security and socio-emotional functioning
Overall trial start date
01/01/2000
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Mothers with an infant not older than 12 months, who met the Diagnostic and Statistical Manual of Mental Disorders fourth edition (DSM-IV) criteria for a major depressive episode or dysthymia and/or exhibited elevated levels of depressive symptoms (Beck Depression Inventory [BDI] >14). Psychiatric comorbidity was allowed.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
71
Participant exclusion criteria
1. Comorbid psychotic disorders
2. Manic depression
3. Substance abuse
Recruitment start date
01/01/2000
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Radboud University Nijmegen
Nijmegen
6500 HE
Netherlands
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Funder name
Dutch Foundation for Childrens Welfare Stamps (Stichting Kinderpostzegels Nederland [SKN]) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18489412
Publication citations
-
Results
van Doesum KT, Riksen-Walraven JM, Hosman CM, Hoefnagels C, A randomized controlled trial of a home-visiting intervention aimed at preventing relationship problems in depressed mothers and their infants., Child Dev, 79, 3, 547-561, doi: 10.1111/j.1467-8624.2008.01142.x.