Interventions for Depressed Low Income Mothers and Their Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00105573
First received: March 15, 2005
Last updated: May 13, 2008
Last verified: May 2008

March 15, 2005
May 13, 2008
January 2004
December 2009   (final data collection date for primary outcome measure)
  • Maternal depression [ Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age ] [ Designated as safety issue: No ]
  • Child development [ Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age ] [ Designated as safety issue: No ]
  • Infant-parent attachment [ Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age ] [ Designated as safety issue: No ]
  • Maternal depression
  • Child development
  • Infant-parent attachment
Complete list of historical versions of study NCT00105573 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Interventions for Depressed Low Income Mothers and Their Infants
Prevention for Infants of Low-Income Depressed Mothers

This study will compare three interventions for depressed, low income mothers and determine which is most effective in treating maternal depression and in fostering development in infants.

Poorly educated, low income mothers are at high risk for becoming depressed. The effects of living in poverty and being reared by a depressed parent can be detrimental to an infant's development. Effective interventions to reduce maternal depression and strengthen the mother-infant relationships are needed.

Participants will be randomly assigned to one of three groups. Group 1 mothers will receive 16 weekly sessions of interpersonal psychotherapy (IP) designed to directly treat maternal depression. Group 1 participants will have monthly follow-up visits for 1 year. Participants in Group 2 will receive 16 weekly sessions of IP followed by 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants. Group 3 mothers will be invited to attend informational meetings as well as be referred to local services available to people with depression.

All mother-child pairs will be evaluated when the child is 12, 16, 24, 36, and 48 months of age. Evaluations will involve questionnaires, diagnostic interviews, developmental assessments, and video- and audio-taped measures.

Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
  • Behavioral: Maternal interpersonal psychotherapy (IP)
    Participants will receive 16 weekly sessions of maternal IP designed to directly treat maternal depression.
  • Behavioral: Infant-parent psychotherapy
    Participants will receive 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants.
  • Behavioral: Informational meetings plus treatment as usual
    Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.
  • Experimental: 1
    Participants will receive interpersonal psychotherapy for depression.
    Intervention: Behavioral: Maternal interpersonal psychotherapy (IP)
  • Experimental: 2
    Participants will receive interpersonal psychotherapy for depression plus 1 year of in-home, infant-parent psychotherapy.
    Interventions:
    • Behavioral: Maternal interpersonal psychotherapy (IP)
    • Behavioral: Infant-parent psychotherapy
  • Active Comparator: 3
    Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.
    Intervention: Behavioral: Informational meetings plus treatment as usual
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
260
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria for Mothers:

  • Current diagnosis of depression
  • Mother of an infant 9 to 11 months of age
  • Low income, defined as less than $25,000 for a family of two or less than $31,400 for a family of three (add approximately $7,960 for each additional family member)

Exclusion Criteria for Mothers:

  • Current substance abuse
  • Severe mental or physical limitations that would interfere with the study
Female
18 Years to 44 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00105573
R01 MH67792, DSIR 84-CTP
 
Dante Cicchetti, PhD, Mount Hope Family Center
National Institute of Mental Health (NIMH)
 
Principal Investigator: Dante Cicchetti, PhD Mount Hope Family Center
National Institute of Mental Health (NIMH)
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP