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ACTIVE NOT RECRUITING
NCT05345834
NA

The DC Mother-Infant Behavioral Wellness Program

Sponsor: Children's National Research Institute

View on ClinicalTrials.gov

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.

Official title: Advancing Perinatal Mental Health and Well-Being: The DC Mother-Infant Behavioral Wellness Program

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

700

Start Date

2022-08-22

Completion Date

2026-11-30

Last Updated

2025-07-24

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Patient Navigation

Participants in arm 2 will receive patient navigation provided by humans (rather than e-navigation) to provide personalized care to include support, resources, and referrals to address psychosocial issues that arise during the perinatal period. Patient navigation is available to participants through 12 months postpartum.

BEHAVIORAL

Adapted Cognitive-Behavioral Therapy

Participants who do not meet diagnostic criteria (Group 2a) will participate in a prevention group which includes 8 sessions based on culturally adapted CBT for Black/ of African descent populations facilitated by mental health professionals. Participants who meet diagnostic criteria (Group 2b) will participate in individual treatment which includes 12 sessions based on culturally adapted CBT for Black/ of African descent populations.

Locations (1)

Unity Healthcare - Brentwood

Washington D.C., District of Columbia, United States