DepressionNCT01665872
New Haven MOMS Partnership
A study testing Cognitive-Behavioral Group Therapy in people with Depression and Stress, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Depression, Stress
- What is being tested?
- Cognitive-Behavioral Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06510
About this study
Official title: New Haven Mental Health Outreach for MotherS (MOMS) Partnership
Phase II of the MOMS Partnership aims to:
- conduct a needs assessment of the mental health of mothers residing in New Haven, CT;
- provide on-site group intervention services (randomized by housing community) to improve signs/symptoms of depression/stress/trauma among mothers living onsite.
Read the detailed description
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
- Conditions
- Depression, Stress
- Being tested
- Cognitive-Behavioral Group Therapy
- Keywords
- Mothers, Depression, Stress, Trauma, Public Housing
- Medical subject headings
- Depression, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Group TherapyBehavioural
Also called CBT Group
CBT Group
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Cognitive-Behavioral Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Gainful Employment
Measure of subject's ability to obtain gainful employment
Measured: 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).
Measured: 1 series
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Office of Research on Women's Health (ORWH)
- Responsible party
- Sponsor
- Investigators
- Megan V Smith, MPH, DrPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665872
- Sponsor's protocol ID
- 1010007484
- Other IDs
- 5CCEWH1110210501
- Status last verified
- Feb 2020
- First submitted
- 13 Aug 2012
- Last updated
- 10 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Haven Mental Health Outreach for MotherS (MOMS) Partnership
- ClinicalTrials.gov ID
- NCT01665872
- Acronym / sponsor ID
- 1010007484
- Conditions
- Depression, Stress
- Keywords
- Mothers, Depression, Stress, Trauma, Public Housing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, Office of Research on Women's Health (ORWH)
- Study start
- May 2012 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Posted 10 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II of the MOMS Partnership aims to:
- conduct a needs assessment of the mental health of mothers residing in New Haven, CT;
- provide on-site group intervention services (randomized by housing community) to improve signs/symptoms of depression/stress/trauma among mothers living onsite.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Group Therapy | Experimental | Behavioral: Cognitive-Behavioral Group Therapy8-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). |
| Standard of care - Cognitive-Behavioral Group Therapy | Active comparator | Behavioral: Cognitive-Behavioral Group Therapy8-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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Positive for psychosis
- Active suicidal ideation
- Non-English or Spanish speakers
- Unable to provide informed consent
- Unwilling to accept randomization
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 |
|---|---|---|
| Cognitive-Behavioral Group TherapyAlso: CBT GroupCBT Group | Behavioural | Cognitive-Behavioral Group Therapy, Standard of care - Cognitive-Behavioral Group Therapy |
Primary outcome
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.
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.
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.
Gainful Employment
Time frame: 1 year
Measure of subject's ability to obtain gainful employment
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, MPH, DrPH principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Group Therapy in people with Depression and Stress, run by Yale University at 1 site 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 10 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 1 site 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?
Yes. Results are posted in the registry (first posted 10 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Outpatient Mental Health or Substance Abuse Visits (time frame: 1 year). The study lists 5 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 10 Feb 2020.