New Haven MOMS Partnership

Not Applicable

Completed

• Conditions: Depression; Stress
• Interventions: Behavioral: Cognitive-Behavioral Group Therapy

• Registration Number: NCT01665872
• Lead Sponsor: Yale University

Brief 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.

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

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-15
• Primary Completion: 2016-08
• Study Completion: 2017-06
• Results First Submitted: 2019-02-15
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-06
• Last Update Submitted: 2020-02-06
• Results First Posted: 2020-02-10
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 154

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-Behavioral Group Therapy	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).
Standard of care - Cognitive-Behavioral Group Therapy	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.

Primary Outcome Measures

Name	Time	Method
Gainful Employment	1 year	Measure of subject's ability to obtain gainful employment
Total Outpatient Mental Health or Substance Abuse Visits	1 year	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.
Depressive and Anxiety Symptoms (CES-D)	approximately 1 year	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.
Parenting Stress	1 year	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.
Implementation Cost	1 series	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).

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States