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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The investigators' mobile application-based community, termed Momba, will provide a bi-directional flow of information on maternal and infant mental health to traditionally underrepresented groups of mothers and their infants. The overall goal of this mobile application-based community of low-income postpartum women and infants is to increase the social support, social networks, and social capital of low-income mothers; thereby, leading to a positive change in the health behaviors, utilization of health services, and mental health status of both mothers and their infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Access to MOMBA web-based application | Experimental | Study will provide the subject with a smartphone, pay the data plan, and facilitate access to the web-based application for purposes of researching the acceptability of the application, the operating and functioning of it, and its impact on maternal mental health. |
|
| Smartphone only | No Intervention | Study will provide the subject with a smartphone and pay the data plan. Weekly assessments are completed through internet survey links sent via text message. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOMBA web-based application | Behavioral | Web-based, interactive, social network application. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phone Retention | To determine the potential feasibility of providing smartphones to participants and delivering and intervention through the smartphone, phone retention was measured. Phone retention was defined as the ability of participants to retain the phone over the study period. Outcome measure used was how many participants did not need a replacement phone during the study period. | 15 months |
| Test the Proper Operating and Functioning of the MOMBA Application | To Test the proper operating and functioning of the MOMBA application, the number of participants that received training was assessed. Intervention subjects were trained (together) on the operating and functions (including how to use the privacy settings) of the Momba application and the phone. The control subjects were trained (together) on how to complete the control questionnaires and how to use the phone. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability and Performance of Structured Questionnaires | To determine the acceptability and performance of structured questionnaires, the measurement is categorized into whether participants did or did not complete the 12 month follow-up interview. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health | Improve maternal emotional health, was measured by the PHQ-9. The Patient Health Questionnaire (PHQ-9) is a 9 item questionnaire that is used to assess depression severity. The scores range from 0-27. A score of 10 or higher can be indicative of a moderate - severe level of depression severity. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan V Smith, 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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| ID | Title | Description |
|---|---|---|
| FG000 | Access to MOMBA Web-based Application | Study will provide the subject with a smartphone, pay the data plan, and facilitate access to the web-based application for purposes of researching the acceptability of the application, the operating and functioning of it, and its impact on maternal mental health. MOMBA web-based application: Web-based, interactive, social network application. |
| FG001 | Smartphone Only | Study will provide the subject with a smartphone and pay the data plan. Weekly assessments are completed through internet survey links sent via text message. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Access to MOMBA Web-based Application | Study will provide the subject with a smartphone, pay the data plan, and facilitate access to the web-based application for purposes of researching the acceptability of the application, the operating and functioning of it, and its impact on maternal mental health. MOMBA web-based application: Web-based, interactive, social network application. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Phone Retention | To determine the potential feasibility of providing smartphones to participants and delivering and intervention through the smartphone, phone retention was measured. Phone retention was defined as the ability of participants to retain the phone over the study period. Outcome measure used was how many participants did not need a replacement phone during the study period. | Posted | Count of Participants | Participants | 15 months |
|
12 months
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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 | Access to MOMBA Web-based Application | Study will provide the subject with a smartphone, pay the data plan, and facilitate access to the web-based application for purposes of researching the acceptability of the application, the operating and functioning of it, and its impact on maternal mental health. MOMBA web-based application: Web-based, interactive, social network application. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan Smith Associate Professor | Yale University | 203 764 8655 | megan.smith@yale.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Confident Network Score |
To assess the improvement maternal emotional health, the Kendler Social Support Interview was used. The Kendler Social Support Interview has scores that range from 0-5, with 5 indicating a larger social network or confidant network size. Presented below are the confident network score at 12 month follow-up. |
| 12 months |
| BG001 | Smartphone Only | Study will provide the subject with a smartphone and pay the data plan. Weekly assessments are completed through internet survey links sent via text message. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PHQ-9 | The Patient Health Questionnaire (PHQ-9) is 9 item questionnaire that is used to assess depression severity. The scores range from 0-27. A score of 10 or higher can be indicative of a moderate - severe level of depression severity. | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| Smartphone Only |
Study will provide the subject with a smartphone and pay the data plan. Weekly assessments are completed through internet survey links sent via text message. |
|
|
|
| Primary | Test the Proper Operating and Functioning of the MOMBA Application | To Test the proper operating and functioning of the MOMBA application, the number of participants that received training was assessed. Intervention subjects were trained (together) on the operating and functions (including how to use the privacy settings) of the Momba application and the phone. The control subjects were trained (together) on how to complete the control questionnaires and how to use the phone. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Acceptability and Performance of Structured Questionnaires | To determine the acceptability and performance of structured questionnaires, the measurement is categorized into whether participants did or did not complete the 12 month follow-up interview. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | Patient Health | Improve maternal emotional health, was measured by the PHQ-9. The Patient Health Questionnaire (PHQ-9) is a 9 item questionnaire that is used to assess depression severity. The scores range from 0-27. A score of 10 or higher can be indicative of a moderate - severe level of depression severity. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| Other Pre-specified | Confident Network Score | To assess the improvement maternal emotional health, the Kendler Social Support Interview was used. The Kendler Social Support Interview has scores that range from 0-5, with 5 indicating a larger social network or confidant network size. Presented below are the confident network score at 12 month follow-up. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Smartphone Only | Study will provide the subject with a smartphone and pay the data plan. Weekly assessments are completed through internet survey links sent via text message. | 0 | 24 | 0 | 24 | 0 | 24 |
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