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 |
| Protocol serial number | NTR457 |
| Sponsor | University Medical Centre St. Radboud (Netherlands) |
| Funders | Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands), Dutch Foundation for Childrens Welfare Stamps (Stichting Kinderpostzegels Nederland [SKN]) (Netherlands) |
- 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
Scientific
Radboud University Nijmegen
Department of Clinical Psychology
Prevention Research Centre
P.O. Box 9104
Nijmegen
6500 HE
Netherlands
| vandoesumk@hetnet.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised single blind placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Quality of the mother-child interaction |
| Key secondary outcome measure(s) |
Infant attachment security and socio-emotional functioning |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 71 |
| Key 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. |
| Key exclusion criteria | 1. Comorbid psychotic disorders 2. Manic depression 3. Substance abuse |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Radboud University Nijmegen
Nijmegen
6500 HE
Netherlands
6500 HE
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
