MOMS Hubs- CT Dept of Social Services Block Grant | NCT02459925

Studies
MOMS Hubs- CT Dept of Social Services Block Grant

NCT02459925

Sponsor

Yale University

Status

Terminated

Last Update Posted

Feb 21, 2020Actual

Enrollment

179Actual

Phase

Not Applicable

Conditions

Depression

Interventions

CBT- Mental Health Program
MOMS GROW

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Apr 22, 2015Actual

Primary Completion Date

May 25, 2017Actual

Completion Date

May 25, 2017Actual

First Submitted Date

Apr 8, 2015

First Submission Date that Met QC Criteria

May 28, 2015

First Posted Date

Jun 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2020

Last Update Posted Date

Feb 21, 2020Actual

Name	Class
Clifford Beers Clinic	UNKNOWN
City of New Haven- Health Department	UNKNOWN
New Paradigms Consulting	UNKNOWN
National Diaper Bank Network

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

179Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CBT- Mental Health Program	Active Comparator	Cognitive Behavioral Therapy. Manualized Stress Management class; brief individual behavioral counseling.	Behavioral: CBT- Mental Health Program
MOMS GROW	Active Comparator	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.	Behavioral: MOMS GROW

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CBT- Mental Health Program	Behavioral	Manualized Stress Management class; brief individual behavioral counseling.	CBT- Mental Health Program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in Center for Epidemiologic Studies Depression (CED-D) Scale	Reduced CES-D Score (CES-D score goal <16)	6 months
Improvement in work readiness skills	Reduced CASAS score	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Megan V Smith, DrPH	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boys & Girls Club of New Haven		New Haven	Connecticut	06510	United States
Center for Wellbeing of Women and Mothers, Dept. of Psychiatry, Yale University

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior