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| ID | Type | Description | Link |
|---|---|---|---|
| 5CCEWH1110210501 | Other Grant/Funding Number | PHS Public Health Service (ORWH) |
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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
| Office of Research on Women's Health (ORWH) | NIH |
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Phase II of the MOMS Partnership aims to:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Group Therapy | Behavioral | CBT Group |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan V Smith, MPH, DrPH | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States |
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Participants were screened throughout the community with a needs assessment during the time frame 05/21/2012 through 06/02/2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive-Behavioral Group Therapy | 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). Cognitive-Behavioral Group Therapy: CBT Group |
| FG001 | Standard of Care - Cognitive-Behavioral Group Therapy | 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. Cognitive-Behavioral Group Therapy: CBT Group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
| |||||||||||||
| Treatment |
| |||||||||||||
| 6 Month Follow-up |
| |||||||||||||
| 12 Month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive-Behavioral Group Therapy | Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador |
| BG001 | Standard of Care - Cognitive-Behavioral Group Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who attended the 12 month follow-up assessment and completed the questions regarding mental health and substance abuse visits. | Posted | Mean | Standard Deviation | visits | 1 year |
|
Adverse event data was monitored for all enrolled participants beginning at enrollment. This continued through engagement in the intervention and all follow-up (1 year post intervention).
The definition does not differ.
Methods for reporting adverse events: any serious, unanticipated and related adverse events or unanticipated problems involving risks to subjects or others will be reported in writing within 48 hours to the HIC and any appropriate funding and regulatory agencies. Fellow investigators and study personnel will be informed through regular study meetings and study sponsors will be informed within 5 days of the event becoming known to the principal investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive-Behavioral Group Therapy | Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Megan Smith | Yale University | 2037648655 | megan.smith@yale.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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 |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Stress Management Class delivered in public housing sites by only a clinician
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| CES-D total score | 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. | Mean | Standard Deviation | units on a scale |
|
| Total outpatient mental health or substance abuse visits | We did not have a response from 3 participants in the Cognitive-Behavioral Group Therapy group | Mean | Standard Deviation | visits |
|
| Parenting Stress Index Short Form: Parental Distress Percentile | Parental Distress is a subscale of Parenting Stress Index Short Form by Richard R. Abidin. This subscale contains 12 questions. The score is the sum of all 12 questions that is then translated to percentiles for normative data (provided by the publisher). This subscale measures distress that the parent is experiencing in their role as a parent as a result of factors related to parenting. High scores indicate more distress. Percentiles range from 0-100. | This measure was only collected on participants whose youngest child was 7 years or younger. | Mean | Standard Deviation | percentile |
|
| Parenting Stress Index: Parent-Child Dysfunctional Interaction Percentile | Parent-Child Dysfunctional Interaction is a subscale (12 questions) of Parenting Stress Index Short Form by Richard R. Abidin. The score is the sum of all 12 questions. This score is then translated to percentiles for normative data (provided by the publisher). The Parent-Child Dysfunctional Interaction subscale measures the parent's perception that a child does or does not meet their expectations and if interactions with the child are reinforcing to the parent. High scores indicate a parent-child bond that is threatened or not adequately established. Percentiles range from 0-100. | This measure was only collected on participants whose youngest child was 7 years or younger. | Mean | Standard Deviation | percentile |
|
| Parenting Stress Index: Difficult Child Percentile | The Difficult Child is a subscale of Parenting Stress Index Short Form by Richard R. Abidin that is created from 12 questions. The score is the sum of all 12 questions. This score is then translated to percentiles for normative data (provided by the publisher). The Difficult Child subscale looks at behavioral characteristics of children (temperament but also patterns of behavior) that make the child easy or difficult to manage. Higher scores generally indicate the parent is experiencing difficulty managing the child's behavior. Percentiles range from 0-100. | This measure was only collected on participants whose youngest child was 7 years or younger. | Mean | Standard Deviation | percentile |
|
| Parenting Stress Index Short Form: Total Score Percentile | Parenting Stress Index Short Form by Richard R. Abidin, contains a total score which is the sum of all 36 questions. The score is then translated to percentiles for normative data (provided by the publisher). The total score is intended to represent an overall level of parenting stress that the individual is experiencing. A score at or above 90 indicates experiencing clinically significant levels of stress. Percentiles range from 0-100. | This measure was only collected on participants whose youngest child was 7 years or younger. | Mean | Standard Deviation | percentile |
|
| Gainful Employment | Do you work 15 hours or more per week for pay? | Count of Participants | Participants |
|
Stress Management Class delivered in public housing sites by only a clinician |
|
|
|
| Primary | 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. | Participants who attended the 12 month follow-up assessment. | Posted | Median | Inter-Quartile Range | units on a scale | approximately 1 year |
|
|
|
|
| Primary | 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. | This questionnaire was only administered to participants who had a child 8 years or older. Results are from participants who attended the 12 month follow-up assessment. | Posted | Median | Inter-Quartile Range | percentile | 1 year |
|
|
|
|
| Primary | Gainful Employment | Measure of subject's ability to obtain gainful employment | Participants who attended 12 month follow-up assessment. | Posted | Count of Participants | Participants | 1 year |
|
|
|
|
| Primary | 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). | Since we are looking at implementation cost this measure isn't participant based, but calculated on what it would cost to run one series. | Posted | Number | American Dollars | 1 series | 1 SM series | 1 SM series |
|
|
|
| 0 |
| 87 |
| 0 |
| 87 |
| 0 |
| 87 |
| EG001 | Standard of Care - Cognitive-Behavioral Group Therapy | Stress Management Class delivered in public housing sites by only a clinician | 0 | 67 | 0 | 67 | 0 | 67 |
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| White, Hispanic |
|
| Black, Hispanic |
|
| Other |
|
| Difficult Child |
|
| Total |
|
| Wilcoxon (Mann-Whitney) |
| 0.3352 |
This test looks at a difference in Parent-Child Dysfunctional Interaction at the 12 month follow-up between groups. |
| Equivalence |
A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits. |
| Wilcoxon (Mann-Whitney) | 0.0404 | This test looks at a difference in Difficult Child at the 12 month follow-up between groups. | Equivalence | A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits. |
| Wilcoxon (Mann-Whitney) | 0.0915 | This test looks at a difference in PSI total score (percentile) at the 12 month follow-up between groups. | Equivalence | A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits. |