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

ISRCTN ISRCTN83523136
DOI https://doi.org/10.1186/ISRCTN83523136
Secondary identifying numbers NTR457
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
17/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Karin Doesum, van
Scientific

Radboud University Nijmegen
Department of Clinical Psychology
Prevention Research Centre
P.O. Box 9104
Nijmegen
6500 HE
Netherlands

Email vandoesumk@hetnet.nl

Study information

Study designMulticentre randomised single blind placebo controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Scientific title
Study objectives1. 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
2. The intervention positively affects the child's attachment security and socio-emotional functioning
Ethics approval(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedDepressive disorders
InterventionIntervention: 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 typeOther
Primary outcome measureQuality of the mother-child interaction
Secondary outcome measuresInfant attachment security and socio-emotional functioning
Overall study start date01/01/2000
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants71
Key inclusion criteriaMothers 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.
Key exclusion criteria1. Comorbid psychotic disorders
2. Manic depression
3. Substance abuse
Date of first enrolment01/01/2000
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Radboud University Nijmegen
Nijmegen
6500 HE
Netherlands

Sponsor information

University Medical Centre St. Radboud (Netherlands)
Hospital/treatment centre

Department of Clinical Psychology
P.O. Box 9104
Nijmegen
6500 HE
Netherlands

ROR logo "ROR" https://ror.org/05wg1m734

Funders

Funder type

Research organisation

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Private sector organisation / Other non-profit organizations
Alternative name(s)
Netherlands Organisation for Health Research and Development
Location
Netherlands
Dutch Foundation for Children’s Welfare Stamps (Stichting Kinderpostzegels Nederland [SKN]) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2008 Yes No