New Haven MOMS Partnership

Depression Clinical Trial

Official title:

New Haven Mental Health Outreach for MotherS (MOMS) Partnership

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665872
• Other study ID #: 1010007484
• Secondary ID: 5CCEWH1110210501
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: June 2017

Study information

• Verified date: February 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: June 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Stress

Intervention

Behavioral:
• Cognitive-Behavioral Group Therapy
CBT Group

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Department of Health and Human Services, Office of Research on Women's Health (ORWH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Outpatient Mental Health or Substance Abuse Visits	Self-report questionnaire which measure attitudes toward seeking mental health treatment. This is defined by looking at total number of outpatient mental health or substance abuse treatment visits in the past year.	1 year
Primary	Depressive and Anxiety Symptoms (CES-D)	The Center for Epidemiologic Studies Depression Scale (CES-D) is a screening test for depression and depressive disorder. The total score is a sum which ranges from 0-60. Higher scores indicate the presence of more symptomatology.; Radloff, L.S. (1977) 'The CES-D scale: A self report depression scale for research in the general population'. Applied Psychological Measurement 1: 385-401.	approximately 1 year
Primary	Parenting Stress	Parenting Stress Index Short Form by Richard R. Abidin (total score (36 questions) and 3 subscales (12 questions each) was used to describe parenting stress. Scores were created by summing the responses and then translated to percentiles for normative data (provided by the publisher). The total score represents an overall level of experienced parenting stress. A score 90 or above indicates experiencing clinically significant levels of stress. The subscale Parental Distress measures distress that the parent is experiencing related to parenting. High scores indicate more distress. The Parent-Child Dysfunctional Interaction subscale measures the parent's perception regarding a child meeting expectations and reinforcing interactions with the child. High scores indicate a parent-child bond that is threatened or not adequately established. The Difficult Child subscale looks at behavioral characteristics of children. Higher scores indicating difficulty managing the child's behavior.	1 year
Primary	Gainful Employment	Measure of subject's ability to obtain gainful employment	1 year
Primary	Implementation Cost	The implementation cost of providing a 8 session Stress Management (SM) Series (with 1 active series at a time) for both Standard of care with only a clinician, and also for a clinician and CMHA. The implementation costs include startup costs and on-going costs. On-going costs include staff salary, travel time, cell phones, space, and materials).	1 series

External Links

•   Study website