Depression, Stress
Conditions
Keywords
Mothers, Depression, Stress, Trauma, Public Housing
Brief 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.
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: 1. 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. 2. To provide randomized intervention services to improve signs/symptoms of depression/stress/trauma among mothers living in public housing in New Haven, CT
Interventions
BEHAVIORALCognitive-Behavioral Group Therapy
CBT Group
Sponsors
Department of Health and Human Services
Office of Research on Women's Health (ORWH)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Outpatient Mental Health or Substance Abuse Visits | 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) | 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 | 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 | 1 year | Measure of subject's ability to obtain gainful employment |
| Implementation Cost | 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). |
Countries
United States
Participant flow
Recruitment details
Participants were screened throughout the community with a needs assessment during the time frame 05/21/2012 through 06/02/2016.
Participants by arm
| Arm | Count |
|---|---|
| Cognitive-Behavioral Group Therapy Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador | 87 |
| Standard of Care - Cognitive-Behavioral Group Therapy Stress Management Class delivered in public housing sites by only a clinician | 67 |
| Total | 154 |
Baseline characteristics
| Characteristic | Cognitive-Behavioral Group Therapy | Standard of Care - Cognitive-Behavioral Group Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 87 Participants | 67 Participants | 154 Participants |
| Age, Continuous | 38.1 years STANDARD_DEVIATION 11 | 39.2 years STANDARD_DEVIATION 11.2 | 38.6 years STANDARD_DEVIATION 11.1 |
| CES-D total score | 28.2 units on a scale STANDARD_DEVIATION 9.3 | 30.4 units on a scale STANDARD_DEVIATION 9.8 | 29.2 units on a scale STANDARD_DEVIATION 9.6 |
| Gainful Employment No | 71 Participants | 59 Participants | 130 Participants |
| Gainful Employment Yes | 16 Participants | 8 Participants | 24 Participants |
| Parenting Stress Index: Difficult Child Percentile | 62.0 percentile STANDARD_DEVIATION 33.6 | 58.9 percentile STANDARD_DEVIATION 31.4 | 60.7 percentile STANDARD_DEVIATION 32.5 |
| Parenting Stress Index: Parent-Child Dysfunctional Interaction Percentile | 61.4 percentile STANDARD_DEVIATION 30 | 59.6 percentile STANDARD_DEVIATION 33.3 | 60.7 percentile STANDARD_DEVIATION 31.2 |
| Parenting Stress Index Short Form: Parental Distress Percentile | 82.4 percentile STANDARD_DEVIATION 21.2 | 73.9 percentile STANDARD_DEVIATION 28.5 | 78.9 percentile STANDARD_DEVIATION 24.7 |
| Parenting Stress Index Short Form: Total Score Percentile | 75.8 percentile STANDARD_DEVIATION 27.6 | 71.4 percentile STANDARD_DEVIATION 29.2 | 74.0 percentile STANDARD_DEVIATION 28.2 |
| Race/Ethnicity, Customized Race / Ethnicity Black, Hispanic | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Black, Non-Hispanic | 68 Participants | 52 Participants | 120 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Other | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Race / Ethnicity White, Hispanic | 11 Participants | 6 Participants | 17 Participants |
| Race/Ethnicity, Customized Race / Ethnicity White, Non-Hispanic | 3 Participants | 5 Participants | 8 Participants |
| Region of Enrollment United States | 87 participants | 67 participants | 154 participants |
| Sex: Female, Male Female | 87 Participants | 67 Participants | 154 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Total outpatient mental health or substance abuse visits | 4.5 visits STANDARD_DEVIATION 16.3 | 2.1 visits STANDARD_DEVIATION 10 | 3.4 visits STANDARD_DEVIATION 13.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 67 |
| other Total, other adverse events | 0 / 87 | 0 / 67 |
| serious Total, serious adverse events | 0 / 87 | 0 / 67 |
Outcome results
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.
Time frame: approximately 1 year
Population: Participants who attended the 12 month follow-up assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cognitive-Behavioral Group Therapy | Depressive and Anxiety Symptoms (CES-D) | 13 units on a scale |
| Standard of Care - Cognitive-Behavioral Group Therapy | Depressive and Anxiety Symptoms (CES-D) | 15 units on a scale |
Comparison: Are CES-D scores at 12 months different between groups?p-value: 0.5337Wilcoxon (Mann-Whitney)
Primary
Gainful Employment
Measure of subject's ability to obtain gainful employment
Time frame: 1 year
Population: Participants who attended 12 month follow-up assessment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cognitive-Behavioral Group Therapy | Gainful Employment | Work 15 hours or more for pay | 19 Participants |
| Cognitive-Behavioral Group Therapy | Gainful Employment | Does not work 15 hours or more for pay | 39 Participants |
| Standard of Care - Cognitive-Behavioral Group Therapy | Gainful Employment | Does not work 15 hours or more for pay | 36 Participants |
| Standard of Care - Cognitive-Behavioral Group Therapy | Gainful Employment | Work 15 hours or more for pay | 11 Participants |
p-value: 0.2914Chi-squared
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).
Time frame: 1 series
Population: Since we are looking at implementation cost this measure isn't participant based, but calculated on what it would cost to run one series.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cognitive-Behavioral Group Therapy | Implementation Cost | 11350 American Dollars |
| Standard of Care - Cognitive-Behavioral Group Therapy | Implementation Cost | 10471 American Dollars |
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.
Time frame: 1 year
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cognitive-Behavioral Group Therapy | Parenting Stress | Parental Distress | 65 percentile |
| Cognitive-Behavioral Group Therapy | Parenting Stress | Parent-Child Dysfunctional Interaction | 42.5 percentile |
| Cognitive-Behavioral Group Therapy | Parenting Stress | Difficult Child | 57.5 percentile |
| Cognitive-Behavioral Group Therapy | Parenting Stress | Total | 65 percentile |
| Standard of Care - Cognitive-Behavioral Group Therapy | Parenting Stress | Total | 15 percentile |
| Standard of Care - Cognitive-Behavioral Group Therapy | Parenting Stress | Parental Distress | 50 percentile |
| Standard of Care - Cognitive-Behavioral Group Therapy | Parenting Stress | Difficult Child | 10 percentile |
| Standard of Care - Cognitive-Behavioral Group Therapy | Parenting Stress | Parent-Child Dysfunctional Interaction | 20 percentile |
p-value: 0.092Wilcoxon (Mann-Whitney)
p-value: 0.3352Wilcoxon (Mann-Whitney)
p-value: 0.0404Wilcoxon (Mann-Whitney)
p-value: 0.0915Wilcoxon (Mann-Whitney)
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.
Time frame: 1 year
Population: Participants who attended the 12 month follow-up assessment and completed the questions regarding mental health and substance abuse visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Group Therapy | Total Outpatient Mental Health or Substance Abuse Visits | 1.03 visits | Standard Deviation 2.95 |
| Standard of Care - Cognitive-Behavioral Group Therapy | Total Outpatient Mental Health or Substance Abuse Visits | 1.21 visits | Standard Deviation 6 |
p-value: 0.172t-test, 2 sided