Results Summary
What was the research about?
Depression is a health problem that makes people feel sad, hopeless, or empty most days. Some women may have depression during pregnancy or after giving birth. Compared with other women, women with low incomes are more likely to feel depressed during or after pregnancy. Women with low incomes may also have a hard time getting mental health care.
In this study, the research team compared two ways to help pregnant women and new mothers with low incomes and symptoms of depression:
- Engagement-focused care coordination, or EFCC. Trained clinic staff met with women once or twice at the clinic to talk about their depression symptoms, learn about treatments, and consider which treatments might work best for them. Staff then helped women find mental health care outside of the clinic.
- Problem-solving education, or PSE. Trained clinic staff met with women six times at the clinic to help them learn to change patterns in their thinking to improve how they feel. If depression symptoms continued, staff connected these women with outside mental health services.
What were the results?
After one year, the programs didn’t differ in women’s improvement in overall depression symptoms. Women in both programs had improvement. Compared with women in the PSE program, women in the EFCC program reported larger declines in serious depression symptoms over one year and had larger declines in parenting stress.
The two programs didn’t differ in:
- Anxiety symptoms
- Knowledge, skill, and confidence about self-care
- Coping skills
- Ability to cope with life challenges
- Use of mental health services
- Children’s behavioral and emotional health
Who was in the study?
The study included 230 women who were pregnant or who had a child who was 18 months old or younger. Of the women, 60 percent were Black, 14 percent were White, 1 percent were Asian, and 24 percent were another race or more than one race. Also, 44 percent were Latina. The women were receiving care at Boston Medical Center. All had Medicaid insurance.
What did the research team do?
The research team assigned women to one of the two programs by chance. Women completed surveys every two months for one year.
Women who had depression after the birth of a child worked with the research team during the study.
What were the limits of the study?
Only about a third of women finished the programs. Results might have differed if more women had completed the programs. The study was conducted in a single medical center. Results may have differed if the study had been done at other locations.
Future research could compare the programs in other locations and look for ways to help more women complete the programs.
How can people use the results?
Health systems can use the results when considering ways to help manage depression symptoms for pregnant women and new moms with low incomes.
Professional Abstract
Objective
To compare the effectiveness of two strategies for improving depression symptoms among pregnant or postpartum women with low incomes
Study Design
Design Element | Description |
---|---|
Design | Randomized controlled trial |
Population | 230 women ages 18 and older with depression symptoms who were receiving care at Boston Medical Center, had Medicaid, and were pregnant or had a child who is 18 months old or younger |
Interventions/ Comparators |
|
Outcomes | Primary: depression symptoms Secondary: anxiety symptoms, behavioral activation, self-efficacy, coping skills, ability to cope with life challenges, parenting stress, child behaviors, engagement and retention with mental health services |
Timeframe | 1-year follow-up for primary outcome |
This randomized controlled trial compared two programs for improving depression symptoms among pregnant and postpartum women with low incomes. Researchers randomly assigned women who screened positive for depression to one of two programs:
- Engagement-focused care coordination (EFCC). Trained clinic staff met one or two times with patients at the clinic. They used shared decision making and motivational interviewing techniques to help patients process their depression screening results, review treatment options, and connect with mental health services. EFCC focused on providing referrals to mental health services.
- Problem-solving education (PSE). Trained clinic staff facilitated a program of six weekly or biweekly cognitive behavioral therapy sessions. PSE focused on offering immediate intervention, followed by a referral to further treatment if symptoms persisted.
The study included 230 women attending Boston Medical Center’s prenatal clinic, pediatrics clinic, or newborn nursery. Of the participants, 60% were Black, 14% were White, 1% were Asian, and 24% identified as another race or more than one race; 44% were Latina.
Women in both groups completed questionnaires every two months.
Women who had depression after the birth of a child provided input on study design, data analysis, and interpretation of the findings.
Results
At one year, women in both programs had improvement in overall depression symptoms, but outcomes among women the two programs did not differ significantly. Compared with women in the PSE program, women in the EFCC program reported greater reductions in severe depression symptoms at one year (p<0.01) and in parenting stress over time (p<0.05). The programs did not differ significantly in how well they improved anxiety or other secondary outcomes.
Limitations
About two-thirds of study participants did not complete the full interventions. Attrition was more pronounced for women in the EFCC program. The study took place in a single medical center, which may limit the generalizability of the findings.
Conclusions and Relevance
In this study, both the EFCC program and the PSE program improved maternal depression over one year. The EFCC program was more effective at improving severe depression.
Future Research Needs
Future studies could compare the two programs at other hospitals and in other geographic areas and explore strategies to encourage more women to complete the programs.
COVID-19-Related Study
Examining the Effects of Two Ways to Support Families with Low Incomes during the COVID-19 Pandemic
Results Summary
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
What was this COVID-19 study about?
During the COVID-19 pandemic, some families with low incomes didn’t have access to enough healthy foods. They also had a hard time getting vaccines for their children to prevent common illnesses.
The research team did two studies to look at how to support families with low incomes during the pandemic.
Study 1 compared how well two food programs worked to help families get enough food to eat and to reduce depression and anxiety in mothers:
- Vouchers. program gave mothers vouchers to buy healthy foods. Healthy foods included fruits, vegetables, grains, and beans. A mobile market delivered food to families at first. Later, mothers could use vouchers at farmers markets and grocery stores.
- Gift cards. The other program gave mothers gift cards to buy whatever they wanted at the grocery store.
In both programs, mothers received $150 each month for six months.
Study 2 looked at whether a mobile health clinic helped children get recommended vaccines on time.
What were the results?
Study 1. After six months, the two food programs did not differ in:
- Families having access to enough healthy food to eat
- Depression and anxiety in mothers
These outcomes improved for families in both food programs.
Study 2. Children who received care from the mobile clinic were more likely to get recommended vaccines on time, compared to all children in the state and country.
What did the research team do?
Study 1. The research team assigned mothers by chance to get vouchers or gift cards. At the start of the study and then monthly for six months, the team asked mothers about their depression and anxiety. They also asked mothers if their family had access to enough healthy food. The study included 250 mothers with a child under age two. Among mothers, 42 percent were Black or African American, 12 percent were White, less than 1 percent were Asian and Other Pacific Islander, 39 percent reported another race, and 6 percent were an unknown race; 58 percent were Latina. The average age was 30.
Study 2. The study included 150 children under age two who went to a mobile clinic for care during the pandemic. The research team looked at children’s health records and public information for vaccine rates. Among children, 43 percent were Black or African American; 4 percent were Asian; 3 percent were White; and 59 percent had a missing, unknown, or other race. Also, 24 percent were Hispanic. The average age was 14 months.
In both studies, children received primary care at Boston Medical Center, which serves families with low incomes in Boston, Massachusetts.
Patient families, clinicians, patient navigators, and hospital administrators gave input during both studies.
What were the limits of the study?
Families received primary care at one health center. Results could differ at other health centers.
How can people use the results?
Clinics can use the results when considering how to help families with low incomes have enough food and get vaccines.
Professional Abstract
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
Background
Disruptions to health care and social services during the COVID-19 pandemic led to concerns that children from families with low incomes would experience decreased access to nutrition and vaccine services.
Objective
(1) To compare the effectiveness of two food programs in improving food security, maternal depression, and anxiety; (2) To examine the effectiveness of a mobile pediatric clinic in delivering vaccines to children
Study Design
Design Element | Description |
---|---|
Design | Study 1: Randomized controlled trial Study 2: Observational study |
Population | Children in both studies received care at a pediatric primary care clinic at Boston Medical Center, a large safety net hospital in Boston; study 1 included 250 mothers with at least 1 child under age 2; study 2 included 150 children under age 2 |
Interventions/Comparators | Study 1: vouchers for purchasing healthy foods (fruits, vegetables, grains, and legumes only) versus unrestricted grocery store gift cards Study 2: vaccine rates for children receiving care at a mobile pediatric clinic versus state and national vaccine rates |
Outcomes | Study 1: food security (primary), maternal depression, anxiety symptoms Study 2: DTaP vaccination rates, MMR vaccination rates |
Data Collection Timeframe | Study 1: February 2021–August 2022; Study 2: April 2020–April 2022 |
Study 1. This randomized controlled trial compared two food assistance programs. Researchers randomized 250 mothers to either:
- Voucher program. Mothers received vouchers to buy healthy foods only. At the start of the COVID-19 pandemic, a mobile market delivered food to participants. Later, participants could use vouchers at neighborhood mobile markets, farmers markets, and grocery stores.
- Gift card program. Mothers received gift cards for unrestricted purchases at grocery stores.
Both groups received $150 monthly for six months. Researchers conducted structured interviews with mothers at baseline and monthly for six months about food security, maternal depression, and anxiety symptoms. Among mothers, 42% were Black or African American, 12% were White, less than 1% were Asian or Other Pacific Islander, 39% reported another race, and 6% did not report a race; 58% were Latina. The average age was 30.
Study 2. This observational study examined the effectiveness of a mobile pediatric clinic for delivering vaccines to children. The mobile clinic delivered curbside medical care during the pandemic. Researchers collected vaccination information from health record data for two years for 150 children under age two after their mobile clinic visit and reviewed publicly available state-level and national vaccine rates. Among children, 43% were Black or African American; 4% were Asian; 3% were White; and 59% had a missing, unknown, or other race; 24% were Hispanic. The average age was 14 months.
Family members, clinicians, patient navigators, and hospital administrators provided input throughout both studies.
Results
Study 1. At six months, the two programs did not differ significantly in food security, maternal depression, or anxiety symptoms. In both programs, food security increased, and depression and anxiety decreased from baseline to six months.
Study 2. Children receiving care from the mobile clinic were more likely to get their third diphtheria, tetanus, and pertussis (DTaP) vaccine by 7 months and their first measles, mumps, and rubella (MMR) vaccine by 13 months, compared with all children in Massachusetts (DTaP: p=0.046; MMR: p=0.013) and the United States (DTaP: p=0.027; MMR at 13 months: p< 0.001). Children receiving care from the mobile clinic had a similar rate of getting their first MMR vaccine by 19 months as all children in Massachusetts, but had a higher rate than all children in the United States (p=0.002).
Limitations
Families received primary care at Boston Medical Center. Results may differ at other health centers.
Conclusions and Relevance
Food security, maternal depression, and anxiety symptoms were similar among mothers in both food assistance programs at the end of six months. The mobile clinic helped children receive on-time vaccinations.
Peer Review Summary
The Peer-Review Summary for this COVID-19 study will be posted here soon.
Final Enhancement Report
This COVID-19 study's final enhancement report is expected to be available by September 2024.
Final Research Report
View this project's final research report.
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers asked for more information about the bachelor’s-trained care advocates in this study, noting that the report was inconsistent in the terminology used to refer to these individuals and it would be helpful for readers to understand their role better to determine whether these care advocates could fit into a variety of clinical settings. To provide greater clarity, the researchers renamed the care advocates “bachelor-level providers” and added information to the report regarding these providers’ training in depression care. The researchers also explained that they did not monitor care sessions closely because this was an effectiveness study; therefore, they wanted to test the intervention in the most real-world environment as possible.
- The reviewers were unclear on what the researchers considered an episode of depression since the Quick Inventory of Depression Symptomatology was measured at multiple intervals.
- The reviewers disagreed with the report’s conclusions that the Engagement-Focused Care Coordination intervention was preferable to the Problem Solving Education condition since the finding was mostly due to depression rates in the comparator group rather than changes in depression in the intervention group. The researchers revised their conclusions to point out the lack of differences between the two groups but felt that without a true control group they could not consider whether the continued presence of depressive symptoms among participants in both treatment groups meant that the treatments did not work.