- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01665872
New Haven MOMS Partnership
New Haven Mental Health Outreach for MotherS (MOMS) Partnership
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
CBT Group
Other Names:
|
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.
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CBT Group
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Outpatient Mental Health or Substance Abuse Visits
Time Frame: 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.
|
1 year
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Depressive and Anxiety Symptoms (CES-D)
Time Frame: 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. |
approximately 1 year
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Parenting Stress
Time Frame: 1 year
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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.
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1 year
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Gainful Employment
Time Frame: 1 year
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Measure of subject's ability to obtain gainful employment
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1 year
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Implementation Cost
Time Frame: 1 series
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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).
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1 series
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Megan V Smith, MPH, DrPH, Yale School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1010007484
- 5CCEWH1110210501 (Other Grant/Funding Number: PHS Public Health Service (ORWH))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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