The DC Mother-Infant Behavioral Wellness Program

RECRUITING

I'm interested ...!!

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

🗓️ Study Start (Actual) 22 August 2022

🗓️ Primary Completion (Estimated) May 2025

✅ Study Completion (Estimated) November 2025

👥 Enrollment (Estimated) 700

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Washington, District of Columbia, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 18 Years to 45 Years (ADULT)

Sexes Eligible for Study: FEMALE

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 2 March 2022
First Submitted that Met QC Criteria 19 April 2022
First Posted 26 April 2022

Study Record Updates

Last Update Submitted that Met QC Criteria 25 June 2024
Last Update Posted 27 June 2024
Last Verified June 2024