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Completed

NCT Number: NCT01665872

New Haven MOMS Partnership

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Stress Wounds and Injuries

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-behavioral group therapy

Behavioral

CBT Group

Other names: CBT Group

Primary outcomes

  1. 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.

  2. 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.

  3. Parenting Stress

    Time frame: 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.

  4. Gainful Employment

    Time frame: 1 year

    Measure of subject's ability to obtain gainful employment

  5. Implementation Cost

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Department of Health and Human Services
  • Office of Research on Women's Health (ORWH)

Registry information

Official study title

New Haven Mental Health Outreach for MotherS (MOMS) Partnership

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Aug 15, 2012
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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