The DC Mother-Infant Behavioral Wellness Program
Purpose
This randomized controlled study will examine the effectiveness of patient navigation with culturally adapted cognitive-behavioral interventions and peer support groups for low-income Black/of African Descent pregnant women who are experiencing stress, anxiety, and/or depression.
Conditions
- Perinatal Depression
- Perinatal Anxiety
- Prenatal Stress
Eligibility
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Black/of African Descent - Pregnant (gestational weeks ≤ 28 weeks) - Age 18-45 - English proficient - Receiving services in 1 of 4 study sites above - Low-income: i.e., receiving Medicaid - Subthreshold or threshold risk for maternal distress (stress, depression, and/or anxiety) - Able to provide consent
Exclusion Criteria
- age <18 - Currently under the influence of a substance(s) - Experiencing psychosis - Critical (clinical) risk: actively suicidal or homicidal - Not Black/of African Descent - Planning to deliver outside DC
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Women in the patient navigator arm (Group 2a) can choose to participate in group-based preventive interventions based on: (1) a culturally adapted CBT (in person within prenatal care site or virtual given COVID); (2) peer support group (virtual); or (3) both. Women in the threshold risk group (Group 2b) at baseline warrant treatment interventions and will be invited to participate in: (1) culturally adapted CBT (individual, in person or virtual given COVID); (2) peer support (virtual); or (3) both. Women in this more severe risk group may be referred for psychiatric treatment if warranted. Randomization lists will be generated by the study statistician using a permuted block design and uploaded to a HIPAA-compliant, password-protected website (REDCap) allowing for patient randomization at the time of registration in the data collection system.
- Primary Purpose
- Other
- Masking
- None (Open Label)
- Masking Description
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Usual Care |
Participants will participate in usual prenatal care throughout the duration of study. |
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Experimental Patient Navigation and treatment |
In the patient navigation arm, women who do not meet diagnostic criteria (Group 2a) can participate in: (1) group-based CBT preventative intervention; (2) peer support group (virtual); or (3) both. Women in the threshold risk group, meeting diagnostic criteria for depression/anxiety (Group 2b) at baseline can participate in: (1) individual CBT treatment (2) peer support group (virtual) (3) both Prevention group includes 8 sessions based on culturally adapted CBT for Black/ of African descent populations facilitated by mental health professionals. Individual treatment includes 12 sessions based on culturally adapted CBT for Black/ of African descent populations. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Children's National Research Institute
Detailed Description
The overarching objective is to develop and evaluate a collaborative, multi-dimensional and culturally tailored community-based model of integrated perinatal MH care. The target population is low-income Black/of African descent women with pregnancy-related stress, anxiety, and depression. There are two specific aims: (1) to refine an individualized plan to integrate patient navigation and a culturally adapted cognitive-behavioral (CBT) intervention for low-income Black/of African Descent women designed to increase recruitment and retention within the healthcare community system, and (2) through a two-arm prospective randomized controlled design, women who are subthreshold and threshold risk for prenatal stress, depression and/or anxiety will participate in one of two interventions: (a) existing prenatal intervention (usual care); or (b) patient navigation plus culturally adapted CBT, and peer support groups. The investigators will screen 1,000 low-income pregnant AA women (18-45 years of age) in their second pregnancy visit with validated tools for stress, anxiety, and depression. A total of 700 study participants will be recruited from urban prenatal care centers in the Washington DC area and will be randomized Usual Care of Intervention conditions above (n=350/condition). Following randomization, participants will participate in a diagnostic interview based on DSM-5 criteria to 'self-select' themselves into 1 of 2 groups (i.e., 'threshold' or 'subthreshold'). Threshold includes women who meet criteria for depression or anxiety based on DSM-5 diagnostic criteria. Subthreshold includes all other women who do not meet DSM criteria). In the intervention arm, participants in the threshold group will receive a 1:1 CBT treatment intervention, and participants in the subthreshold group will receive a group CBT intervention. Both threshold groups will also include patient navigation and participation in a peer support group. Participants will complete standardized health, mental health, and well-being questionnaires during pregnancy at their prenatal site, and up to 12 months after delivery at their well-baby visits, when they also will complete questionnaires about their infants' development and behavior. All infants also will undergo a standardized developmental test at 12 months. Health care utilization and outcomes also will be collected through electronic medical records.
