New Haven MOMS Partnership
This study is currently recruiting participants.
Verified February 2013 by Yale University
Sponsor:
Yale University
Collaborators:
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
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Purpose
Phase II of the MOMS Partnership aims to:
- conduct a needs assessment of the mental health of mothers residing in New Haven, CT;
- 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 Behavioral: Case Management |
| 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
|
Behavioral: Cognitive-Behavioral Group Therapy
CBT Group
Other Name: CBT Group
|
|
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
|
Behavioral: Case Management
Case Management
Other Name: Case Management services, based upon the Wraparound Milwaukee Model of Case Management
|
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:
- 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.
- 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
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
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: | February 14, 2013 |
| 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 June 17, 2013