New Haven MOMS Partnership

NCT ID: NCT01665872

Last Updated: 2020-02-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Depression Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Cognitive-Behavioral Group Therapy

Intervention Type BEHAVIORAL

CBT Group

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.

Group Type ACTIVE_COMPARATOR

Cognitive-Behavioral Group Therapy

Intervention Type BEHAVIORAL

CBT Group

Interventions

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Cognitive-Behavioral Group Therapy

CBT Group

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT Group

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Department of Health and Human Services

FED

Sponsor Role collaborator

Office of Research on Women's Health (ORWH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Megan V Smith, MPH, DrPH

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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5CCEWH1110210501

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1010007484

Identifier Type: -

Identifier Source: org_study_id

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