Clinical trial NCT05345834: The DC Mother-Infant Behavioral Wellness Program
Official title: Advancing Perinatal Mental Health and Well-Being: The DC Mother-Infant Behavioral Wellness Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perinatal Depression
Perinatal Anxiety
Prenatal Stress
Keywords: Postpartum depression
postpartum anxiety
pregnancy
Black women
stress
Anxiety
Depression
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: George Washington University
name: Patient-Centered Outcomes Research Institute
First posted: 2022-04-26
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Stress at 24 weeks of pregnancy to 12 months postpartum
timeFrame: Stress will be measured at 24 weeks of pregnancy through infant age of 12 months
measure: Change in Depression at 24 weeks of pregnancy to 12 months postpartum
timeFrame: 2nd Obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum
measure: Change in Anxiety at 24 weeks of pregnancy to 12 months postpartum
timeFrame: 2nd Obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Unity Healthcare - Brentwood
state: District of Columbia
Study officials:
References: