New Haven MOMS Partnership

NCT01665872 | Completed Results

• 2 other identifiers: 10100074845CCEWH1110210501
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II of the MOMS Partnership aims to:

1. 1.conduct a needs assessment of the mental health of mothers residing in New Haven, CT;
2. 2.provide on-site group intervention services (randomized by housing community) to improve signs/symptoms of depression/stress/trauma among mothers living onsite.

Conditions

Depression; Stress

Keywords

Mothers; Depression; Stress; Trauma; Public Housing

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• Gainful Employment

  Measure of subject's ability to obtain gainful employment

  1 year

• 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

Study Arms (2)

Cognitive-Behavioral Group Therapy

EXPERIMENTAL

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).

Behavioral: Cognitive-Behavioral Group Therapy

Standard of care - Cognitive-Behavioral Group Therapy

ACTIVE COMPARATOR

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.

Behavioral: Cognitive-Behavioral Group Therapy

Interventions

Cognitive-Behavioral Group Therapy BEHAVIORAL

CBT Group

Also known as: CBT Group

Cognitive-Behavioral Group Therapy; Standard of care - Cognitive-Behavioral Group Therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Department of Health and Human Services: collaborator
• Office of Research on Women's Health (ORWH): collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Related Links

• Study website

MeSH Terms

Conditions

Depression; Wounds and Injuries

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

Limitations include subjects self-selected to participate and uncertainty in the representativeness of our sample to all residents of public housing. The ICER could not be calculated due to similarity in CES-D scores in both groups.

Results Point of Contact

• Title: Dr. Megan Smith
• Organization: Yale University

megan.smith@yale.edu

2037648655

Study Officials

• Megan V Smith, MPH, DrPH

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 15, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: June 1, 2017
• Last Updated: February 10, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-02

Locations

US (1)