DepressionMOMS-HubsNCT02459925
MOMS Hubs- CT Dept of Social Services Block Grant
A study testing CBT- Mental Health Program and MOMS GROW in people with Depression, run by Yale University at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression
- What is being tested?
- CBT- Mental Health Program and MOMS GROW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Apr 2015to 25 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Signs or symptoms of active psychosis or active suicidality will be a basis for exclusion in the study.
- Lack of proficiency in English.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Boys & Girls Club of New Haven
New Haven, Connecticut, 06510
Center for Wellbeing of Women and Mothers, Dept. of Psychiatry, Yale University
New Haven, Connecticut, 06510
Stop & Shop
New Haven, Connecticut, 06510
West Rock Author's Academy
New Haven, Connecticut, 06510
About this study
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
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.
Read the 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.
- Conditions
- Depression
- Being tested
- CBT- Mental Health Program, MOMS GROW
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT- Mental Health ProgramBehavioural
Manualized Stress Management class; brief individual behavioral counseling.
MOMS GROWBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT- Mental Health Program | Active comparator | Cognitive Behavioral Therapy. Manualized Stress Management class; brief individual behavioral counseling. Receives: 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. Receives: Behavioral: MOMS GROW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Center for Epidemiologic Studies Depression (CED-D) Scale
Reduced CES-D Score (CES-D score goal <16)
Measured: 6 months
Improvement in work readiness skills
Reduced CASAS score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study start22 Apr 2015
- Primary completion25 May 2017
- Study completion25 May 2017
Why it stopped: Due to funding that was never obtained, the MOMS Grow arm was not completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Megan V Smith, DrPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459925
- Sponsor's protocol ID
- 1409014610
- Acronym
- MOMS-Hubs
- Status last verified
- Feb 2020
- First submitted
- 8 Apr 2015
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02459925
- Acronym / sponsor ID
- MOMS-Hubs / 1409014610
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to funding that was never obtained, the MOMS Grow arm was not completed.
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- 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
- Study start
- 22 Apr 2015 (actual)
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT- Mental Health Program | Active comparator | Behavioral: CBT- Mental Health ProgramCognitive Behavioral Therapy. Manualized Stress Management class; brief individual behavioral counseling. |
| MOMS GROW | Active comparator | Behavioral: MOMS GROWMOMS 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Signs or symptoms of active psychosis or active suicidality will be a basis for exclusion in the study.
- Lack of proficiency in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT- Mental Health ProgramManualized Stress Management class; brief individual behavioral counseling. | Behavioural | CBT- Mental Health Program |
| MOMS GROWMOMS 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. | Behavioural | MOMS GROW |
Primary outcome
Improvement in Center for Epidemiologic Studies Depression (CED-D) Scale
Time frame: 6 months
Reduced CES-D Score (CES-D score goal <16)
Improvement in work readiness skills
Time frame: 6 months
Reduced CASAS score
Results and safety
The study was stopped early (reason given: Due to funding that was never obtained, the MOMS Grow arm was not completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan V Smith, DrPH principal investigator
Yale University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT- Mental Health Program and MOMS GROW in people with Depression, run by Yale University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to funding that was never obtained, the MOMS Grow arm was not completed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Center for Epidemiologic Studies Depression (CED-D) Scale (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.