The DC Mother-Infant Behavioral Wellness Program

NCT ID: NCT05345834

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-22
• Study Completion Date: 2026-11-30

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.

Conditions

Perinatal Depression; Perinatal Anxiety; Prenatal Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Usual Care

Participants will participate in usual prenatal care throughout the duration of study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Patient Navigation

Intervention Type: BEHAVIORAL

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.

Adapted Cognitive-Behavioral Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Maternity Care Specialist; Adapted CBT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

George Washington University

OTHER

Sponsor Role: collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Children's National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Catherine Limperopoulos

Director of the Developing Brain Institute and Director of the Advanced Pediatric Brain Imaging Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Unity Healthcare - Brentwood

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

Countries

United States

References

Le HN, Andescavage N, Keller JM, Bassa MM, Danielson AL, Henderson D, Bond S, Mjenga N, Wells S, Quinn P, Limperopoulos C. Protocol for a randomized controlled trial of the Mommy&Me study: A multi-modal approach to address social determinants of health and mental health among low-income Black perinatal populations. Contemp Clin Trials Commun. 2025 Apr 21;45:101489. doi: 10.1016/j.conctc.2025.101489. eCollection 2025 Jun.

Reference Type: DERIVED

PMID: 40336702 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00015379

Identifier Type: -

Identifier Source: org_study_id