Condition category
Mental and Behavioural Disorders
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
17/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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

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

Sponsor information

Organisation

University Medical Centre St. Radboud (Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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 Children’s 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

  1. 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.

Additional files

Editorial Notes