New Haven MOMS Partnership

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Yale University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Megan Smith, Yale University
ClinicalTrials.gov Identifier:
NCT01665872
First received: August 13, 2012
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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.

Condition Intervention
Depression
Stress
Behavioral: Cognitive-Behavioral Group Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: New Haven Mental Health Outreach for MotherS (MOMS) Partnership

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 160
Study Start Date: September 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Behavioral: Cognitive-Behavioral Group Therapy
CBT Group
Other Name: CBT Group
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.
Behavioral: Cognitive-Behavioral Group Therapy
CBT Group
Other Name: CBT Group

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665872

Contacts
Contact: Kia Levey, MSW (203) 764-8601 kia.levey@yale.edu
Contact: Heather B Howell, MSW (203) 764-6615 heather.howell@yale.edu

Locations
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Principal Investigator: Megan V Smith, MPH, DrPH         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Megan V Smith, MPH, DrPH Yale School of Medicine
Study Director: Kia Levey, MSW Yale School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Megan Smith, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT01665872     History of Changes
Other Study ID Numbers: CCEWH111021 MOMS
Study First Received: August 13, 2012
Last Updated: September 12, 2014
Health Authority: United States: Federal Government (DHHS)
United States: Institutional Review Board

Keywords provided by Yale University:
Mothers
Depression
Stress
Trauma
Public Housing

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014