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MOMS Hubs- CT Dept of Social Services Block Grant (MOMS-Hubs)

Primary Purpose

Depression

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CBT- Mental Health Program

MOMS GROW

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria are as follows:

Participant is a woman raising a child or adolescent under 18 years of age. The child/adolescent may be her biological offspring or in her custody due to adoption or foster care. Care arrangements may be legally sanctioned or informal, as is common in New Haven families. Thus, the eligible participant may be a sister, aunt, grandmother, or other female responsible for the daily care of children.
Participant currently resides within the city limits of New Haven, CT.
Participant resided within County of New Haven, CT on October 29, 2012.
Participant's income is at or below 325% of the Federal poverty income.
Participant is a U.S. citizen.
Participant's score on CES-D > 16.

Exclusion criteria are as follows:

Signs or symptoms of active psychosis or active suicidality will be a basis for exclusion in the study.
Lack of proficiency in English.

Sites / Locations

Boys & Girls Club of New Haven
Center for Wellbeing of Women and Mothers, Dept. of Psychiatry, Yale University
Stop & Shop
West Rock Author's Academy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

CBT- Mental Health Program

MOMS GROW

Arm Description

Cognitive Behavioral Therapy. Manualized Stress Management class; brief individual behavioral counseling.

MOMS GROW (Generating Real Opportunities for Work) Teaching, coaching, and supportive services for participants as they navigate their journeys to sustainable employment that pays a family-supporting wage.

Outcomes

Primary Outcome Measures

Improvement in Center for Epidemiologic Studies Depression (CED-D) Scale

Reduced CES-D Score (CES-D score goal <16)

Improvement in work readiness skills

Reduced CASAS score

Secondary Outcome Measures

Full Information

NCT ID

NCT02459925

First Posted

April 8, 2015

Last Updated

February 19, 2020

Sponsor

Yale University

Collaborators

Clifford Beers Clinic, City of New Haven- Health Department, New Paradigms Consulting, National Diaper Bank Network, The New Haven Diaper Bank, Third Sector Capital Partners

1. Study Identification

Unique Protocol Identification Number

NCT02459925

Brief Title

MOMS Hubs- CT Dept of Social Services Block Grant

Acronym

MOMS-Hubs

Official Title

MOMS Partnership-Community-Based Hubs for Maternal Mental Health and Workforce Development, New Haven MOMS Partnership- CT Dept of Social Services Block Grant

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Terminated

Why Stopped

Due to funding that was never obtained, the MOMS Grow arm was not completed.

Study Start Date

April 22, 2015 (Actual)

Primary Completion Date

May 25, 2017 (Actual)

Study Completion Date

May 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

Clifford Beers Clinic, City of New Haven- Health Department, New Paradigms Consulting, National Diaper Bank Network, The New Haven Diaper Bank, Third Sector Capital Partners

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The MOMS Partnership aims to create "MOMS Zones" in New Haven neighborhoods where the hardest to reach families live. These "MOMS Zones" will have two unique features: (1) a MOMS "Hub" to deliver centralized mental health and family economic success services to the hardest to reach families living in New Haven's most impoverished neighborhoods, as measured by actual socio-economic status as well as by access to resources; (2) a neighborhood workforce of Community Mental Health Ambassadors (CMHAs--mothers who themselves live in New Haven). The MOMS Workforce Program and MOMS Mental Health Program will be offered at all three Hubs.

Detailed Description

The MOMs workforce program will involve teaching, coaching, and supportive services for participants as they navigate their journeys to sustainable employment that pays a family-supporting wage. Participants will be guided through an individualized progression of services designed to increase their employability, to increase their ability to earn higher incomes in career-track employment, and to improve their chances of retaining jobs and advancing in them. The MOMS Mental Health program centers around a manualized Stress Management Course 8-class group treatment, delivered once per week. The course was adapted from "The Mother and Child Course" by Munoz and Le (2011) for the population of New Haven mothers who are served by the MOMS Partnership.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

179 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBT- Mental Health Program

Arm Type

Active Comparator

Arm Description

Cognitive Behavioral Therapy. Manualized Stress Management class; brief individual behavioral counseling.

Arm Title

MOMS GROW

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

CBT- Mental Health Program

Intervention Description

Manualized Stress Management class; brief individual behavioral counseling.

Intervention Type

Behavioral

Intervention Name(s)

MOMS GROW

Intervention Description

Primary Outcome Measure Information:

Title

Improvement in Center for Epidemiologic Studies Depression (CED-D) Scale

Description

Reduced CES-D Score (CES-D score goal <16)

Time Frame

6 months

Title

Improvement in work readiness skills

Description

Reduced CASAS score

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria are as follows: Participant is a woman raising a child or adolescent under 18 years of age. The child/adolescent may be her biological offspring or in her custody due to adoption or foster care. Care arrangements may be legally sanctioned or informal, as is common in New Haven families. Thus, the eligible participant may be a sister, aunt, grandmother, or other female responsible for the daily care of children. Participant currently resides within the city limits of New Haven, CT. Participant resided within County of New Haven, CT on October 29, 2012. Participant's income is at or below 325% of the Federal poverty income. Participant is a U.S. citizen. Participant's score on CES-D > 16. Exclusion criteria are as follows: Signs or symptoms of active psychosis or active suicidality will be a basis for exclusion in the study. Lack of proficiency in English.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Megan V Smith, DrPH

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boys & Girls Club of New Haven

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Center for Wellbeing of Women and Mothers, Dept. of Psychiatry, Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Stop & Shop

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

West Rock Author's Academy

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

12. IPD Sharing Statement

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MOMS Hubs- CT Dept of Social Services Block Grant

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