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New Haven MOMS Partnership

This study is currently recruiting participants.
Verified February 2013 by Yale University
Sponsor:
Collaborators:
Department of Health and Human Services
Office of Research on Women's Health (ORWH)
Information provided by (Responsible Party):
Megan Smith, Yale University
ClinicalTrials.gov Identifier:
NCT01665872
First received: August 13, 2012
Last updated: February 14, 2013
Last verified: February 2013
History of Changes

August 13, 2012
February 14, 2013
September 2011
August 2016   (final data collection date for primary outcome measure)
  • Attitude toward seeking mental health treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Self-report questionnaire which measure attitudes toward seeking mental health treatment
  • Depressive and anxiety symptoms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Signs/symptoms of depression and anxiety, as measured by self-report questionnaires
  • Parenting stress [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Selt-report questionnaire which measures level of stress among mothers
  • Gainful employment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measure of subject's ability to obtain gainful employment
  • Cost [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Relative cost-effectiveness of our cognitive-behavioral intervention will be assessed using incremental cost-effectiveness ratios.
Same as current
Complete list of historical versions of study NCT01665872 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
New Haven MOMS Partnership
New Haven Mental Health Outreach for MotherS (MOMS) Partnership

Phase II of the MOMS Partnership aims to:

  1. conduct a needs assessment of the mental health of mothers residing in New Haven, CT;
  2. provide on-site group intervention services (randomized by housing community) to improve signs/symptoms of depression/stress/trauma among mothers living onsite.

The purpose of this project is to expand and enhance the New Haven Mental health Outreach for Mothers (MOMs) Coalition beyond pregnancy and depression to include a broader definition of mental illness (depressive, anxiety, and substance use disorders), and a larger target population (low-income, racially and ethnically diverse, pregnant and parenting women) in the City of New Haven. Through this expansion, the Coalition will bring together the community of women, their families and advocates, healthcare providers, policy and agency leaders, and academics, to inform the development and conduct of public health approaches around the mental health of low-income, racially and ethnically diverse, pregnant and parenting women. The specific goals of this Phase I proposal are:

  1. To conduct a community-led needs assessment on the mental health of low-income, ethnically and racially diverse pregnant and parenting women in the City of New Haven.
  2. To provide randomized intervention services to improve signs/symptoms of depression/stress/trauma among mothers living in public housing in New Haven, CT
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Depression
  • Stress
  • Behavioral: Cognitive-Behavioral Group Therapy
    CBT Group
    Other Name: CBT Group
  • Behavioral: Case Management
    Case Management
    Other Name: Case Management services, based upon the Wraparound Milwaukee Model of Case Management
  • Experimental: Cognitive-Behavioral Group Therapy
    8-session Cognitive-Behavioral intervention based on Munoz et al's Mother Baby Manual, modified to meet the needs of mothers of children of all ages residing in public housing in New Haven, CT
    Intervention: Behavioral: Cognitive-Behavioral Group Therapy
  • Active Comparator: Case Management
    Case Management services to connect study subjects with appropriate behavioral health services in the community, based upon the Wraparound Milwaukee Model of Case Management
    Intervention: Behavioral: Case Management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
August 2016
August 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • CES-D score >=16
  • Child under the age of 18 (participant must be a mother)
  • Resident of public housing authority complex in New Haven, CT

Exclusion Criteria:

  • Positive for psychosis
  • Active suicidal ideation
  • Non-English or Spanish speakers
  • Unable to provide informed consent
  • Unwilling to accept randomization
  • Moving within the intervention & follow-up period
Female
16 Years and older
No
Contact: Kia Levey, MSW (203) 764-8601 kia.levey@yale.edu
Contact: Heather B Howell, MSW (203) 764-6615 heather.howell@yale.edu
United States
 
NCT01665872
CCEWH111021 MOMS
No
Megan Smith, Yale University
Yale University
  • Department of Health and Human Services
  • Office of Research on Women's Health (ORWH)
Principal Investigator: Megan V Smith, MPH, DrPH Yale School of Medicine
Study Director: Kia Levey, MSW Yale School of Medicine
Yale University
February 2013

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