The DC Mother-Infant Behavioral Wellness Program

NCT05345834 | Active Not Recruiting

• 1 other identifier: Pro00015379
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Depression; Perinatal Anxiety; Prenatal Stress

Keywords

Postpartum depression; postpartum anxiety; pregnancy; Black women; stress; Anxiety; Depression

Outcome Measures

Primary Outcomes (3)

• Change in Stress at 24 weeks of pregnancy to 12 months postpartum

  Perceived Stress Scale: A 10-item questionnaire to measure the self-reported level of stress in the respondents by assessing feelings and thoughts during the last month. Each item is scored from 0 (never) to 5 (very often) with a range of 0 to 40 for the total score of the scale. A higher level of stress is indicated by higher scores on this scale.

  Stress will be measured at 24 weeks of pregnancy through infant age of 12 months

• Change in Depression at 24 weeks of pregnancy to 12 months postpartum

  Edinburgh Postnatal Depression Scale: A 10-item scale used to indicate whether a parent has symptoms that are common in women with depression during pregnancy and in the year following the birth of a child. Each item is scored from 0 (As much as I ever did) to 3 (Not at all) with a range of 0 to 30. Higher level of depression is indicated by a higher score on this scale.

  2nd Obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum

• Change in Anxiety at 24 weeks of pregnancy to 12 months postpartum

  General Anxiety Disorder-7 (GAD-7): A 7-item scale to measure levels of anxiety in respondents by assessing feelings and thoughts over the past 2 weeks. Each item is scored from 0 (Not at all) to 3 (Nearly every day) with a range of 0 to 21. Higher level of depression is indicated by a higher score on this scale.

  2nd Obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum

Study Arms (2)

Usual Care

NO INTERVENTION

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

Patient Navigation and treatment

EXPERIMENTAL

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.

Behavioral: Patient Navigation; Behavioral: Adapted Cognitive-Behavioral Therapy

Interventions

Patient Navigation 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.

Also known as: Maternity Care Specialist

Patient Navigation and treatment

Adapted Cognitive-Behavioral Therapy 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.

Also known as: Adapted CBT

Patient Navigation and treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's National Research Institute: lead
• George Washington University: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Unity Healthcare - Brentwood

Washington D.C., District of Columbia, 20018, United States

Location

Related Publications (1)

• 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.

  PMID: 40336702 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders; Depression

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Developing Brain Institute and Director of the Advanced Pediatric Brain Imaging Research Program

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: April 26, 2022
• Study Start: August 22, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

US (1)