Mental Health Wellness 1
Conditions
Keywords
Depression, Stress, Social support, Social capital, Maternal
Brief summary
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.
Interventions
BEHAVIORALMOMBA web-based application
Web-based, interactive, social network application.
Sponsors
National Institute of Mental Health (NIMH)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women will be recruited in their third trimester of pregnancy from Yale-New Haven Hospital (YNHH) and followed for 8 months postpartum. * Women are eligible if they are over the age of 18, in their third trimester of pregnancy, will deliver a baby at YNHH and receive prenatal care at the Women's Center. * Meet criteria for minor or major depressive disorder.
Exclusion criteria
* Mothers are not eligible to participate if they have previously given birth * Are placing the baby for adoption * Are planning to move in the next 18 months * Are actively suicidal, psychotic or unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phone Retention | 15 months | 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. |
| Test the Proper Operating and Functioning of the MOMBA Application | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability and Performance of Structured Questionnaires | 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Health | 12 months | 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. |
| Confident Network Score | 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| 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. | 24 |
| Total | 47 |
Baseline characteristics
| Characteristic | Access to MOMBA Web-based Application | Smartphone Only | Total |
|---|---|---|---|
| Age, Customized Age category 18-25 | 12 Participants | 12 Participants | 24 Participants |
| Age, Customized Age category 26+ | 11 Participants | 12 Participants | 23 Participants |
| PHQ-9 | 7.74 units on a scale STANDARD_DEVIATION 5.34 | 11.25 units on a scale STANDARD_DEVIATION 6.21 | 9.53 units on a scale STANDARD_DEVIATION 6 |
| Race/Ethnicity, Customized Race / Ethnicity Black or African American, Hispanic | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Black or African American, Non-Hispanic | 18 Participants | 16 Participants | 34 Participants |
| Race/Ethnicity, Customized Race / Ethnicity White, Hispanic | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Race / Ethnicity White, Non-Hispanic | 3 Participants | 3 Participants | 6 Participants |
| Region of Enrollment United States | 23 participants | 24 participants | 47 participants |
| Sex: Female, Male Female | 23 Participants | 24 Participants | 47 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 24 |
| other Total, other adverse events | 0 / 23 | 0 / 24 |
| serious Total, serious adverse events | 0 / 23 | 0 / 24 |
Outcome results
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.
Time frame: 15 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Access to MOMBA Web-based Application | Phone Retention | Received 1 phone | 9 Participants |
| Access to MOMBA Web-based Application | Phone Retention | Received a replacement phone | 14 Participants |
| Smartphone Only | Phone Retention | Received 1 phone | 15 Participants |
| Smartphone Only | Phone Retention | Received a replacement phone | 9 Participants |
p-value: 0.15Fisher Exact
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.
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Access to MOMBA Web-based Application | Test the Proper Operating and Functioning of the MOMBA Application | Number of participants trained to use phone | 23 Participants |
| Access to MOMBA Web-based Application | Test the Proper Operating and Functioning of the MOMBA Application | Number of participants who did not receive training | 0 Participants |
| Smartphone Only | Test the Proper Operating and Functioning of the MOMBA Application | Number of participants trained to use phone | 24 Participants |
| Smartphone Only | Test the Proper Operating and Functioning of the MOMBA Application | Number of participants who did not receive training | 0 Participants |
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.
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Access to MOMBA Web-based Application | Acceptability and Performance of Structured Questionnaires | Participants who completed a 12 month follow-up interview | 20 Participants |
| Access to MOMBA Web-based Application | Acceptability and Performance of Structured Questionnaires | Participants who did not completed a 12 month follow-up interview | 3 Participants |
| Smartphone Only | Acceptability and Performance of Structured Questionnaires | Participants who completed a 12 month follow-up interview | 19 Participants |
| Smartphone Only | Acceptability and Performance of Structured Questionnaires | Participants who did not completed a 12 month follow-up interview | 5 Participants |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Access to MOMBA Web-based Application | Confident Network Score | 2.35 score on a scale | Standard Deviation 1.39 |
| Smartphone Only | Confident Network Score | 1.5 score on a scale | Standard Deviation 1.1 |
Comparison: Two-sample t-test for Social Network Score at 12 monthp-value: 0.043t-test, 2 sided
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Access to MOMBA Web-based Application | Patient Health | 5.6 score on a scale | Standard Deviation 4.75 |
| Smartphone Only | Patient Health | 5.68 score on a scale | Standard Deviation 6.37 |
Comparison: Two-sample t-test for PHQ-9 at 12 monthsp-value: 0.96t-test, 2 sided