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New Haven MOMS Partnership

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01665872
First Posted: August 15, 2012
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Department of Health and Human Services
Office of Research on Women's Health (ORWH)
Information provided by (Responsible Party):
Yale University
August 13, 2012
August 15, 2012
August 2, 2017
September 2011
August 2016   (Final data collection date for primary outcome measure)
  • Attitude toward seeking mental health treatment [ Time Frame: 1 year ]
    Self-report questionnaire which measure attitudes toward seeking mental health treatment
  • Depressive and anxiety symptoms [ Time Frame: 1 year ]
    Signs/symptoms of depression and anxiety, as measured by self-report questionnaires
  • Parenting stress [ Time Frame: 1 year ]
    Selt-report questionnaire which measures level of stress among mothers
  • Gainful employment [ Time Frame: 1 year ]
    Measure of subject's ability to obtain gainful employment
  • Cost [ Time Frame: 1 year ]
    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: None (Open Label)
Primary Purpose: Treatment
  • Depression
  • Stress
Behavioral: Cognitive-Behavioral Group Therapy
CBT Group
Other Name: CBT Group
  • 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 co-facilitated by mental health clinician and a Community Mental Health Ambassador (peer).
    Intervention: Behavioral: Cognitive-Behavioral Group Therapy
  • Active Comparator: Standard of care - 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 administered by mental health clinician.
    Intervention: Behavioral: Cognitive-Behavioral Group Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
June 2017
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 or an affiliated Section 8 recipient

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
Sexes Eligible for Study: Female
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01665872
1010007484
5CCEWH1110210501 ( Other Grant/Funding Number: PHS Public Health Service (ORWH) )
No
Not Provided
Not Provided
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
Yale University
July 2017

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